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“œ M MM Ä

Danger

SECTION 1. Identification de la substance/du mélange et de la société/l’entreprise 1.1. Identificateur de produit Identification du produit Nom commercial Numéro CAS Numéro EINECS Formule chimique Numéro d'enregistrement Reach

: PERSULFATE DE SODIUM : : : :

7775-27-1 231-892-1 Na2S2O8 01-2119495975-15-XXXX

1.2. Utilisations identifiées pertinentes de la substance ou du mélange et utilisations déconseillées Industriel. 1.3. Renseignements concernant le fournisseur de la fiche de données de sécurité ALTICHEM 4 RUE JACQUES VAUCANSON Z.I. DU VERT GALANT 95310 SAINT-OUEN-L'AUMÔNE - FRANCE B 451 011 548 RCS PONTOISE Tél : +33 (0)1 34 40 12 80 [email protected] 1.4. Numéro d’appel d’urgence N° ORFILA : +33 (0)1 45 42 59 59

SECTION 2. Identification des dangers 2.1. Classification de la substance ou du mélange Classification CE 67/548 ou CE 1999/45 : O; R8 Xn; R22 Xi; R36/37/38 Xn ; R42/43

Classification

Code(s) des classes et catégories de danger, Règlement (CE) Nº 1272/2008 (CLP) : Toxicité aiguë, par voie orale - Catégorie 4 - Attention - (CLP : Acute Tox. 4) - H302 Irritation cutanée - Catégorie 2 - Attention - (CLP : Skin Irrit. 2) Irritation oculaire - Catégorie 2A - Attention - (CLP : Eye Irrit. 2) - H319 Sensibilisation respiratoire - Catégorie 1 - Danger - (CLP : Resp. Sens. 1) - H334 Sensibilisation cutanée - Catégorie 1 - Attention - (CLP : Skin Sens. 1) - H317 Toxicité spécifique pour certains organes cibles - Exposition unique - Catégorie 2 Attention - (CLP : STOT SE 2) - H371 : Matières solides comburantes - Catégorie 3 - Attention - (CLP : Ox. Sol. 3) - H272

• Dangers pour la santé

• Dangers physiques 2.2. Éléments d’étiquetage

Règlement d'Etiquetage CE 1272/2008 (CLP)

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SECTION 2. Identification des dangers (suite)

M “ M œ M Ä

• Pictogramme(s) de danger

: GHS08 - GHS03 - GHS07 : Danger : H272 - Peut aggraver un incendie; comburant. H302 - Nocif en cas d'ingestion. H319 - Provoque une sévère irritation des yeux. H315 - Provoque une irritation cutanée. H334 - Peut provoquer des symptômes allergiques ou d'asthme ou des difficultés respiratoires par inhalation. H317 - Peut provoquer une allergie cutanée. H335 - Peut irriter les voies respiratoires.

• Pictogramme(s) de danger • Mention d’avertissement • Mention de danger

• Conseils de prudence : P210 - Tenir à l’écart de la chaleur/des étincelles/des flammes nues/des surfaces chaudes. — Ne pas fumer. P220 - Tenir/stocker à l’écart des vêtements/matières combustibles P285 - Lorsque la ventilation du local est insuffisante, porter un équipement de protection respiratoire. : P305+P351+P338 - EN CAS DE CONTACT AVEC LES YEUX: rincer avec précaution à l’eau pendant plusieurs minutes. Enlever les lentilles de contact si la victime en porte et si elles peuvent être facilement enlevées. Continuer à rincer. : P405 - Garder sous clef. : P501 - Eliminer ce produit et son récipient dans un centre de collecte des déchets dangereux ou spéciaux. : Liste des phrases P pertinentes : P210-P220-P261-P264-P270-P271-P280-P285P301+P310-P330-P302+P352-P333+P313-P362-P304+P340-P305+P351+P338P337+P313-P312-P403+P233-P405-P501

Prévention

Intervention

Stockage Considérations relatives à l'élimination Note :

2.3. Autres dangers : Résultats des évaluations PBT et vPvB : Aucun(e)s dans des conditions normales.

Autres dangers

SECTION 3. Composition/informations sur les composants Nom de la substance

Peroxodisulfate de disodium

:

Contenance 100 %

No CAS 7775-27-1

No CE 231-892-1

Numéro index -----

REACH 01-2119495975-15-XXXX

Classification Xn; R22 Xi; R36/37/38 R42/43 ---------------------------------Ox. Sol. 3;H272 Acute Tox. 4 (Oral);H302 Skin Irrit. 2;H315 Eye Irrit. 2;H319 Resp. Sens. 1;H334 Skin Sens. 1;H317 STOT SE3; H335

Voir fiche d'analyse pour des informations détaillées.

SECTION 4. Premiers secours 4.1. Description des premiers secours - Inhalation

: Transporter la personne incommodée à l'air frais. Maintenir au chaud et dans un endroit calme. Si la respiration devient difficile, appeler un médecin. Le cas échéant, administrer de

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SECTION 4. Premiers secours (suite) l'oxygène ou pratiquer la respiration artificielle. En cas d'inconscience, coucher et transporter la personne en position latérale stable. : Enlever immédiatement tous vêtements souillés ou éclaboussés. En cas de contact avec la peau, rincer abondamment à l'eau. En cas de malaise consulter un médecin (si possible lui montrer l'étiquette). : Laver immédiatement et abondamment à l'eau, en écartant les paupières (pendant au moins 15 minutes). Consulter un ophtalmologiste. : Se rincer la bouche à l'eau puis boire beaucoup d'eau. NE PAS faire vomir. Consulter immédiatement un médecin.

- Contact avec la peau

- Contact avec les yeux - Ingestion Premiers secours

4.2. Principaux symptômes et effets, aigus et différés : Traitement symptomatique. Des symptômes peuvent apparaître ultérieurement. Risque d'oedème pulmonaire. Observation des électrolytes et des fonctions rénales.

Autres informations

4.3. Indication des éventuels soins médicaux immédiats et traitements particuliers nécessaires Traitement symptomatique. Des symptômes peuvent apparaître ultérieurement. Risque d'oedème pulmonaire. Observation des électrolytes et des fonctions rénales.

SECTION 5. Mesures de lutte contre l’incendie 5.1. Moyens d’extinction : Ininflammable. Utiliser des moyens d'extinction appropriés aux conditions locales et à l'environnement voisin. - Agents d'extinction non appropriés : Aucune donnée disponible. - Agents d'extinction appropriés

5.2. Dangers particuliers résultant de la substance ou du mélange : Comburant. Favorise l'inflammation des matières combustibles. Fort échauffement (décomposition). : Dégagement de : Dioxyde de soufre. Trioxyde de soufre. Ammoniac. Oxydes nitriques (NOx) Ozone.

Risques spécifiques

5.3. Conseils aux pompiers Protection contre l'incendie Autres informations

: Port d'un masque respiratoire autonome. Tout le personnel de lutte anti-incendie doit porter des combinaisons de protection. : Si possible, évacuer les récipients exposés au feu, sinon les refroidir avec d'abondantes quantités d'eau. La chaleur peut provoquer une pressurisation et l'éclatement des conteneurs clos, propageant le feu et augmentant le risque de brûlures/blessures. Collecter séparément l’eau d’extinction contaminée. Ne pas laisser s’infiltrer dans les égouts, cours d’eau ou le sol.

SECTION 6. Mesures à prendre en cas de dispersion accidentelle 6.1. Précautions individuelles, équipement de protection et procédures d’urgence

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SECTION 6. Mesures à prendre en cas de dispersion accidentelle (suite) Précautions individuelles

: Porter des vêtements de protection appropriés. Eviter le contact avec la substance. Ne pas respirer les poussières. Assurer une aération suffisante. Tenir à l'écart des matières combustibles.

6.2. Précautions pour la protection de l’environnement Précautions pour l'environnement

: Ne pas laisser s’infiltrer dans les égouts, cours d’eau ou le sol. Le cas échéant s'adresser aux autorités compétentes.

6.3. Méthodes et matériel de confinement et de nettoyage : Eviter la formation de poussière. Récupérer à l'état sec. Les petites quantités : Neutraliser avec : Thiosulfate de sodium ( Solution ). Nettoyer.

Méthodes de nettoyage

6.4. Référence à d'autres sections Voir Rubrique 13.

SECTION 7. Manipulation et stockage 7.1. Précautions à prendre pour une manipulation sans danger : - Indications pour l'utilisation en toute sécurité : Assurer une aération suffisante. Travailler sous une hotte. Manipuler et ouvrir le récipient avec prudence. Ne pas laisser ouverts les fûts et les récipients. Éviter tout contact avec la peau, les yeux et les vêtements. Ne pas respirer les poussières. Indications pour la protection contre l'incendie et l'explosion : Conserver à l'écart de toute flamme ou source d'étincelles - Ne pas fumer. Travaux de soudage interdits.

Manipulation

7.2. Conditions d’un stockage sûr, y compris d’éventuelles incompatibilités : Conserver le récipient bien fermé et à l'abri de l'humidité. Entreposer à température ambiante. Protéger de la lumière solaire, de la chaleur et des effets de la chaleur. Matériaux appropriés : Verre , Céramiques , PVC, PE, PP. : Tenir à l'écart des matières combustibles. Tenir séparé des produits alimentaires.

Stockage

Stockage - à l'abri de

7.3. Utilisation(s) finale(s) particulière(s) Aucune donnée disponible.

SECTION 8. Contrôles de l’exposition/protection individuelle 8.1. Paramètres de contrôle Le présent document s'appuie sur les listes en vigueur au moment de son élaboration. Observer les règlements nationaux. Limites d'exposition professionnelle 8.2. Contrôles de l’exposition

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SECTION 8. Contrôles de l’exposition/protection individuelle (suite) Contrôles de l’exposition Mesures techniques Protection individuelle - Protection respiratoire - Protection de la peau - Protection des yeux - Protection des mains

Contrôle d'exposition lié à la protection de l'environnement Mesures d'hygiène

: Veiller à une bonne ventilation/aspiration du poste de travail. Doit toujours être manipulé en système fermé. : : En cas de formation de poussière : Porter un masque anti-poussière P2, P3. ( EN143) : Porter des vêtements résistant au feu/aux flammes/ignifuges. : Lunettes de protection hermétiques. (EN 166) : Porter des gants de protection. (EN 374) Matériaux appropriés : Caoutchouc nitrile , Caoutchouc chloroprène. Temps de pénétration : > 480 min Le temps de pénétration exact est à déterminer par le fabricant des gants de protection et à respecter. Choix du matériau des gants en fonction des temps de pénétration, du taux de perméabilité et de la dégradation. : Aucune donnée disponible. : Enlever immédiatement tout vêtement souillé ou éclaboussé. Ne pas manger, ne pas boire et ne pas fumer pendant l'utilisation. Se laver les mains avant les pauses et en fin de travail. S'assurer de la proximité d'une douche oculaire et d'une douche de sécurité au poste de travail.

SECTION 9. Propriétés physiques et chimiques 9.1. Informations sur les propriétés physiques et chimiques essentielles 9.1.a. Aspect : Solide : Blanc(he).

Etat physique Couleur 9.1.b. Odeur

: Inodore.

Odeur 9.1.c. Seuil olfactif Aucune donnée disponible. 9.1.d. pH pH

: 20°C, 100 g/L : 3.5-3.8

9.1.e. Point de fusion / Point de congélation Point de fusion [°C]

: 180 °C ( Décomposition )

9.1.f. Point initial d’ébullition et intervalle d’ébullition T° d'ébullition [°C]

: ( Décomposition ).

9.1.g. Point d'éclair

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SECTION 9. Propriétés physiques et chimiques (suite) : Non combustible.

Point d'éclair [°C] 9.1.h. Taux d'évaporation Aucune donnée disponible. 9.1.i. Inflammabilité

: Comburant .

Inflammabilité

9.1.j. Limites supérieures/inférieures d’inflammabilité ou limites d’explosivité Aucune donnée disponible. 9.1.k. Pression de vapeur Aucune donnée disponible. 9.1.l. Densité de vapeur Aucune donnée disponible. 9.1.m. Densité relative : 20 °C : 2.4-2.6 g/cm3

Densité 9.1.n. Solubilité(s)

: 20°C : 545 g/L 60°C : 680 g/L

Solubilité dans l'eau

9.1.o. Coefficient de partage : n-octanol / eau Aucune donnée disponible. 9.1.p. Température d'auto-inflammabilité Aucune donnée disponible. 9.1.q. Température de décomposition Décomposition thermique

: ca. 180°C

9.1.r. Viscosité Aucune donnée disponible. 9.1.s. Propriétés explosives Aucune donnée disponible. 9.1.t. Propriétés comburantes O : Comburant 9.2. Autres informations : 238,1 g/mol

Masse moléculaire

SECTION 10. Stabilité et réactivité 10.1. Réactivité Aucune donnée disponible. 10.2. Stabilité chimique

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SECTION 10. Stabilité et réactivité (suite) Aucune donnée disponible. 10.3. Possibilité de réactions dangereuses Hygroscopique. Comburant : ( Dégagement de : Oxygène. ). 10.4. Conditions à éviter : Protéger de l'humidité. Conserver à l'écart de la chaleur. Décomposition : ( Dans l'eau ) : formation de : Peroxyde d'hydrogène . Oxygène . Risque d'incendie . Réagit avec : Alcool. formation de : Oxygène , Dioxyde de soufre. . Tenir à l'écart des matières combustibles.

Conditions à éviter

10.5. Matières incompatibles : Acides forts. Sels de métaux lourds. Agents réducteurs . Composés de l'ammonium. Cyanures. Matière combustible .

Matières à éviter

10.6. Produits de décomposition dangereux Produits de décomposition dangereux

: Fort échauffement (décomposition) : Dégagement de : Dioxyde de soufre.

SECTION 11. Informations toxicologiques 11.1. Informations sur les effets toxicologiques : DL50 - Oral - Rat : 895-920 mg/kg (IUCLID) : Les poussières peuvent causer une sévère irritation des voies respiratoires. Toux . Dyspnée. Risque d'oedème pulmonaire. Des symptômes peuvent apparaître ultérieurement . : Nocif. - Ingestion • Corrosion cutanée/irritation cutanée : Très irritant pour la peau. • Lésions oculaires graves/irritation : Très irritant pour les yeux. oculaire : Aucune donnée disponible. • Sensibilisation respiratoire ou cutanée : Aucune donnée disponible. • Mutagénicité sur les cellules germinales : Aucune donnée disponible. • Cancérogénicité : Aucune donnée disponible. • Toxicité pour la reproduction : Aucune donnée disponible. • Toxicité spécifique pour certains organes cibles — exposition unique : Peut irriter les voies respiratoires. • Toxicité spécifique pour certains organes cibles – exposition répétée : Aucune donnée disponible. • Danger par aspiration : Peut entraîner une sensibilisation par inhalation et par contact avec la peau. Autres données Maux de tête . Nausées. Vomissements. Toxicité aiguë - Inhalation

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SECTION 12. Informations écologiques 12.1. Toxicité Informations toxicologiques Toxicité aquatique

: Effets nocifs en cas de modification du pH. Toxicité pour les daphnies : EC50 Daphnia magna : 133 mg/L/48h. NOEC Daphnia magna 67.6 mg/L/48h. Toxicité pour les poissons : CL50 Lepomis macrochirus : 771 mg/L/96h. NOEC Lepomis macrochirus : 391 mg/L/96h. Source : IUCLID.

12.2. Persistance et dégradabilité Persistance et dégradabilité

: Décomposition / Hydrolyse : formation de : Acide sulfurique

12.3. Potentiel de bioaccumulation Aucune donnée disponible. 12.4. Mobilité dans le sol Aucune donnée disponible. 12.5. Résultats des évaluations PBT et VPVB Aucune donnée disponible. 12.6. Autres effets néfastes Information relative aux effets écologiques Autres informations

: Ne pas laisser pénétrer dans la nappe phréatique, les eaux ou les canalisations. : WGK 1 : Considéré comme mettant faiblement en danger la qualité de l'eau.

SECTION 13. Considérations relatives à l’élimination 13.1. Méthodes de traitement des déchets Elimination des déchets

: Produit : Code d'élimination de déchet : 160904*= substances oxydantes non spécifiées ailleurs Eliminer comme déchets spéciaux conformément aux réglementations locales et nationales. Emballages : Détruire conformément aux règlements de sécurité locaux/nationaux en vigueur.

SECTION 14. Informations relatives au transport 14.1. Numéro ONU UN1505

14.2. Nom d’expédition des Nations unies Persulfate de sodium (Sodium persulphate)

14.3. Classe(s) de danger pour le transport - ADR/RID N° de danger : 50

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SECTION 14. Informations relatives au transport (suite) Désignation technique exacte : UN 1505, Persulfate de sodium Classe 5.1, Code : O2 Groupe d'emballage : III Etiquette : 5.1 Quantité limitée : LQ12 Equipement spécial de sécurité : E1 Conditionnement : P002 IBC08 LP02 R001 Conditionnement : Réglementé. B3 , MP10 Récipients T1 , TP33, SGAV Code de restriction en tunnels (ADR) : E - ADN Désignation technique exacte : UN 1505, Persulfate de sodium ADN/ADNR : Classe 5.1, Code : O2 Groupe d'emballage : III Etiquette : 5.1 Quantité limitée : LQ12 Equipement spécial de sécurité : E1, PP - IMDG N° UN : 1505 Désignation technique exacte : Persulfate de sodium Classe 5.1, Code : Groupe d'emballage : III EmS : F-A, S-Q Quantité limitée : 5 kg Equipement spécial de sécurité : E1 Conditionnement : P002, LP02 IBC : IBC08 IBC : Réglementé. B3 Récipients T1, TP33 Stowage and segregation : Catégorie A - . " séparé de " Composés de l'ammonium autres que PERSULFATE D'AMMONIUM ( UN 1444) , Cyanures. Propriétés : Blanc(he). Cristaux / Poudre. Soluble dans l'eau. Les mélanges avec des matériaux combustibles sont sensibles à la friction et sont susceptibles de s'enflammer. Réagit violemment avec les cyanures quand il est chauffé ou par friction. Peut former un mélange explosif avec des poudres métalliques ou des composés de l'ammonium. Polluant Marin (MP) : NON - IATA N° UN : 1505 Désignation technique exacte : Persulfate de sodium ICAO/IATA : Classe 5.1 Danger : Oxydant. Groupe d'emballage : III EQ : E1 Instruction d'emballage passager : Y516 - Quantité limitée : 10 kg 516 - Quantité limitée : 25 kg Cargo : 518 Quantité limitée : 100 kg ERG : 5L Etiquette(s) de danger

14.4. Groupe d’emballage

t

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SECTION 14. Informations relatives au transport (suite) III

14.5. Dangers pour l'environnement Polluant Marin (MP) : NON

14.6. Précautions particulières à prendre par l’utilisateur Aucune donnée disponible.

14.7. Transport en vrac conformément à l’annexe II de la convention MARPOL 73/78 et au recueil IBC Non applicable

SECTION 15. Informations réglementaires 15.1. Réglementations/législation particulières à la substance ou au mélange en matière de sécurité, de santé et d’environnement S'assurer que toutes les réglementations nationales ou locales sont respectées. Règlement (CE) no 1272/2008 relatif à la classification, à l’étiquetage et à l’emballage des substances et des mélanges Directives 67/548/CEE et 1999/45/CE Annexe XIV - Liste des substances soumises à autorisation : Substances extrêmement préoccupantes : Aucun des composants n'est répertorié. Annexe XVII - Restrictions applicables à la fabrication, à la mise sur le marché et à l'utilisation de certaines substances et préparations dangereuses et de certains articles dangereux : Non applicable. : Observer les règlements nationaux. Autres 15.2. Évaluation de la sécurité chimique Aucune donnée disponible.

SECTION 16. Autres informations Texte des Phrases R du § 3

: R22 : Nocif en cas d'ingestion. R36/37/38 : Irritant pour les yeux, les voies respiratoires et la peau. R42/43 : Peut entraîner une sensibilisation par inhalation et par contact avec la peau.

Texte des Phrases H du § 3

: H272 - Peut aggraver un incendie; comburant. H302 - Nocif en cas d'ingestion. H315 - Provoque une irritation cutanée. H317 - Peut provoquer une allergie cutanée. H319 - Provoque une sévère irritation des yeux. H334 - Peut provoquer des symptômes allergiques ou d'asthme ou des difficultés respiratoires par inhalation. H335 - Peut irriter les voies respiratoires. : Aucun(e).

Autres données Etiquetage CE 67/548 ou CE 1999/45 Symbole(s)

Phrase(s) R

ê O ê X

: Comburant. Nocif. : R8 : Favorise l'inflammation des matières combustibles. R22 : Nocif en cas d'ingestion. R36/37/38 : Irritant pour les yeux, les voies respiratoires et la peau.

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SECTION 16. Autres informations (suite)

Phrase(s) S

R42/43 : Peut entraîner une sensibilisation par inhalation et par contact avec la peau. : S22 : Ne pas respirer les poussières. S24 : Eviter le contact avec la peau. S26 : En cas de contact avec les yeux, laver immédiatement et abondamment avec de l'eau et consulter un spécialiste. S37 : Porter des gants appropriés. S45 : En cas d'accident ou de malaise, consulter immédiatement un médecin (si possible lui montrer l'étiquette).

FICHE DE DONNÉES DE SÉCURITÉ conforme au Règlement (CE) No. 1907/2006. DENEGATION DE RESPONSABILITE Les informations contenues dans cette fiche proviennent de sources que nous considérons être dignes de foi. Néanmoins, elles sont fournies sans aucune garantie, expresse ou tacite, de leur exactitude. Les conditions ou méthodes de manutention, stockage, utilisation ou élimination du produit sont hors de notre contrôle et peuvent ne pas être du ressort de nos compétences. C'est pour ces raisons entre autres que nous déclinons toute responsabilité en cas de perte, dommage ou frais occasionnés par ou liés d'une manière quelconque à la manutention, au stockage, à l'utilisation ou à l'élimination du produit. Cette FDS a été rédigée et doit être utilisée uniquement pour ce produit. Si le produit est utilisé en tant que composant d'un autre produit, les informations s'y trouvant peuvent ne pas être applicables. Fin du document

ALTICHEM 4 RUE JACQUES VAUCANSON

Z.I. DU VERT GALANT 95310 SAINT-OUEN-L'AUMÔNE FRANCE

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SCC Project No. 375-007 12 November 2010

EXPOSURE ASSESSMENT

The following overview provides a summary of uses, product categories (PCs), process categories (PROCs) and relevant environmental release categories (ERCs) for each lifecycle steps of Persulfate Category. Use 0: Manufacturing Sector of use:

NA

Product category:

NA

Process categories: PROC 1 “Use in closed process, no likelihood of exposure” PROC 2 “Use in closed, continuous process with occasional controlled exposure (e.g. sampling)” PROC 3 “Use in closed batch process (synthesis or formulation)” PROC 4 “Use in batch and other process (synthesis) where opportunity for exposure arises” PROC 5 “Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact)” PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b “Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities” PROC 9 “Transfer of substance or preparation into small containers (dedicated filling line, including weighing)” PROC14 “Production of preparations or articles by tabletting, compression, extrusion, pelletisation” Article category:

NA

Environmental release category/Specific environmental release category: ERC 1 “Manufacture of substances” Use 1: Formulation Sector of use:

NA

Product category:

NA

Process categories:

PROC 1 “Use in closed process, no likelihood of exposure” PROC 2 “Use in closed, continuous process with occasional controlled exposure (e.g. sampling)” PROC 3 “Use in closed batch process (synthesis or formulation)” Page 110 of 323 12/119

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PROC 4 “Use in batch and other process (synthesis) where opportunity for exposure arises” PROC 5 “Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact)” PROC 6 “Calendering operations” PROC 8a “Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities” PROC 8b “Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities” PROC 9 “Transfer of substance or preparation into small containers (dedicated filling line, including weighing)” Filling lines specifically designed to both capture vapour and aerosol emissions and minimise spillage PROC 13 “Treatment of articles by dipping and pouring” PROC 14 “Treatment of articles by dipping and pouring” PROC 15 “Use as laboratory reagent” Article category:

NA

Environmental release category/Specific environmental release category: ERC 2 “Formulation of preparations” Use 2: Industrial use Sector of use:

SU 3 “Industrial use”

Product category:

NA

Process categories:

PROC 1 “Use in closed process, no likelihood of exposure” PROC 2 “Use in closed, continuous process with occasional controlled exposure (e.g. sampling)” PROC 3 “Use in closed batch process (synthesis or formulation)” PROC 4 “Use in batch and other process (synthesis) where opportunity for exposure arises” PROC 5 “Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact)” PROC 7 “Industrial spraying” PROC 8a “Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities”

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PROC 8b “Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities” PROC 9 “Transfer of substance or preparation into small containers (dedicated filling line, including weighing)” PROC 10 “Roller application or brushing” PROC 13 “Treatment of articles by dipping and pouring” PROC 14 “Treatment of articles by dipping and pouring” PROC 15 “Use as laboratory reagent” PROC 22 “Potentially closed processing operations with minerals/metals at elevated temperature” PROC 23 “Open processing and transfer operations with minerals/metals at elevated temperature” Article category:

NA

Environmental release category/Specific environmental release category: ERC 6a “Industrial use resulting in manufacture of another substance (use of intermediates)” ERC 6b “Industrial use of reactive processing aids” ERC 6d “Industrial use of process regulators for polymerisation processes in production of resins, rubbers, polymers” Use 3: Professional use Sector of use:

SU 22 “Professional uses: Public domain (administration, education, entertainment, services, craftsmen)”

Product category:

NA

Process categories:

PROC 8a “Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities” PROC 8b “Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities” PROC 9 “Transfer of substance or preparation into small containers (dedicated filling line, including weighing)” PROC 10 “Roller application or brushing” PROC 11 “Non industrial spraying” PROC 13 “Treatment of articles by dipping and pouring” PROC 14 “Treatment of articles by dipping and pouring” Page 112 of 323 14/119

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PROC 15 “Use as laboratory reagent” PROC 19 “Potentially closed processing operations with minerals/metals at elevated temperature” PROC 23 “Open processing and transfer operations with minerals/metals at elevated temperature” Article category:

NA

Environmental release category/Specific environmental release category: ERC 8b “Wide dispersive indoor use of reactive substances in open systems” ERC 8e “Wide dispersive outdoor use of processing aids in open systems” Use 4: Consumer use Sector of use:

SU 21 “Consumer uses: Private households (= general public = consumers)”

Product category: PC electroplating products”

14

“Metal

surface

treatment products, including galvanic

and

PC 37 “Water treatment chemicals” PC 39 “Cosmetics, personal care products” Process categories:

NA

Article category:

NA

Environmental release category/Specific environmental release category: ERC 8b “Wide dispersive indoor use of reactive substances in open systems” ERC 8e “Wide dispersive outdoor use of processing aids in open systems”

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Overview of exposure scenarios Overview on exposure scenarios and coverage of substance life cycle

40000

ES 2

40000

X

X

Linked to identified use

Sector of use (SU)

Preparation category (PC) or Article category (AC)

Process category (PROC)

Environmental release category (ERC) A/B Table Industry category /Use category (IC/UC)

Use 0

NA

NA

ERC 1

Use 1

NA

NA

Use 2

SU 3

NA

PROC 1 PROC 2 PROC 3 PROC 4 PROC 5 PROC 8a PROC 8b PROC 9 PROC 14 PROC 1 PROC 2 PROC 3 PROC 4 PROC 5 PROC 6 PROC 8a PROC 8b PROC 9 PROC 13 PROC 14 PROC 15 PROC 1 PROC 2 PROC 3 PROC 4 PROC 5 PROC 7

Waste stage

ES 1

x

Resulting life cycle stage

Service life (for articles)

30000

Consumer use

ES 0

Identified uses

End use

Volume (tonnes)

Manufacture

ES number

Formulation

Table 44

ERC 2

ERC 6a, 6b, 6d

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ES 3

40000

ES 4

40000

X

X

Linked to identified use

Sector of use (SU)

Preparation category (PC) or Article category (AC)

Process category (PROC)

Environmental release category (ERC) A/B Table Industry category /Use category (IC/UC)

Waste stage

Resulting life cycle stage

Service life (for articles)

Consumer use

End use

Identified uses

Formulation

Volume (tonnes)

Manufacture

ES number

SCC Project No. 375-007 12 November 2010

Use 3

SU 22

NA

Use 4

SU 21

PC 14 PC 37 PC 39

PROC 8a PROC 8b PROC 9 PROC 10 PROC 13 PROC 14 PROC 15 PROC 22 PROC 23 PROC 8a PROC 8b PROC 9 PROC 10 PROC 11 PROC 13 PROC 14 PROC 15 PROC 19 PROC 23

ERC 8b, 8e

ERC 8b, 8e

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9.1

Use 0 Manufacturing

9.1.1

Exposure scenario

SCC Project No. 375-007 12 November 2010

1. Title Free short title

Manufacturing

Systematic title based on use descriptor Processes, tasks activities covered

SU3 Industrial Manufacturing (all) Manufacturing, transfer and packaging

Assessment Method

ECETOC TRA

2. Operational conditions and risk management measures PROC 1 Use in closed process, no likelihood of exposure Use of the substances in high integrity contained system where little potential exists for exposures, e.g. any sampling via closed loop systems. PROC 2 Use in closed, continuous process with occasional controlled exposure (e.g. sampling). Continuous process but where the design philosophy is not specifically aimed at minimizing emissions. It is not high integrity and occasional expose will arise e.g. through maintenance, sampling and equipment breakages. PROC 3 Use in closed batch process (synthesis or formulation) Batch manufacture of a chemical or formulation where the predominant handling is in a contained manner, e.g. through enclosed transfers, but where some opportunity for contact with chemicals occurs, e.g. through sampling. PROC 4 Use in batch and other process (synthesis) where opportunity for exposure arises Use in batch manufacture of a chemical where significant op-opportunity for exposure arises, e.g. during charging, sampling or discharge of material, and when the nature of the design is likely to result in exposure. PROC 5 Mixing or blending in batch process for formulation of preparations and articles (multistage and/or significant contact) Manufacture or formulation of chemical products or articles using technologies related to mixing and blending of solid or liquid materials, and where the process is in stages and provides the opportunity for significant contact at any stage. PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9 Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Filling lines specifically designed to both capture vapour and aerosol emissions and minimise spillage. PROC 14 Production of preparations or articles by tabletting, compression, extrusion, pelletisation ERC 1 Manufacture of substances Manufacture of organic and inorganic substances in chemical, petro-chemical, primary metals and minerals industry including intermediates, monomers using continuous processes or batch processes applying dedicated or multi-purpose equipment, either technically con-trolled or operated by manual interventions. Industry category 2: chemical industry: basic chemicals (UC 37: oxidizing agents) Number of sites: min. 2 2.1 Control of workers exposure Page 116 of 323 18/119

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Product characteristics Concentration: ca. 100 % Physical state: solid Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight packaging: 25 and 50 kg polyethylene bags, 1 t big bag (polypropylene coated textile) Amounts used NA Frequency and duration of use/exposure Duration [for one worker]: max. 24 hours/day Frequency [for one worker]: max. 360 days/year Human factors not influenced by risk management Respiration volume under conditions of use: 10 m3/8h-day (light activity) Area of potential skin contact under conditions of use: two hands and face (480 cm2) Body weight: 70 kg (worker) Other given operational conditions affecting workers exposure Wearing of protective clothing/personal protective equipment is mandatory. Technical conditions and measures at process level (source) to prevent release Local exhaust ventilation is installed, with exhaust air scrubbers/filters (99.9 % removal efficiency). Waste water neutralisation (99.9 % removal efficiency) Technical conditions and measures to control dispersion from source towards the worker Keep container tightly closed in a cool and dry place. Storage away from foodstuffs, reducing agents, heavy-metal compounds, acids and alkalis, protected from humidity and water. Protect from sources of heat. Store not together with inflammable substances. Organisational measures to prevent /limit releases, dispersion and exposure All personnel are trained. Conditions and measures related to personal protection, hygiene and health evaluation General protective and hygienic measures: Keep away from foodstuffs, beverages and food. Take off immediately all contaminated clothing. Clean skin thoroughly immediately after handling the product. Ensure that washing facilities are available in the work place. Avoid contact with the eyes and skin. Do not breathe dust. • Breathing equipment (according to EN 143): In case of brief exposure or low pollution use breathing filter apparatus (half mask P2 APF 10). • Protection of hands (according to EN 374): material: rubber or PVC or other plastic material gloves, glove thickness: 0.5 mm, break through time: >= 8 h • Eye protection (according to EN 166): tightly sealed safety goggles, face protection • Skin and body protection: Light weight protective clothing, rubber or neoprene footwear 2.2 Control of environmental exposure Product characteristics Concentration: ca. 100 % Physical state: solid Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight packaging: 25 and 50 kg polyethylene bags, 1 t big bag Page 117 of 323 19/119

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(polypropylene coated textile) Amounts used Fraction of the main local source: 0.6 Annual amount: 30000 t/year Emission days per site: max. 360 days/year Frequency and duration of use Continuous release; 300 days/year Environment factors not influenced by risk management Dilution factor: rivers = 100 (default = 10), coastal zones = 1000 (default = 100) Other given operational conditions affecting environmental exposure There is practically no disposal or run-off into soil, wastewater, drains and sewers. Technical conditions and measures at process level (source) to prevent release Substance release to air or soil can be practically excluded. Production occurs to a large extent in closed systems (exception: bagging). Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Local exhaust ventilation is installed, with exhaust air scrubbers/filters (99.9 % removal efficiency). Waste water is recycled in production process (i.e. wash water from gas washer/filter cake) or neutralised and detoxified (99.9 % removal efficiency). There is no direct release to soil. Organizational measures to prevent/limit release from site All personnel are trained. Waste water and discharge of solid waste is monitored periodically. Conditions and measures related to municipal sewage treatment plant 2000 m3/day (default) Conditions and measures related to external treatment of waste for disposal Normally there is no waste, as batches out of specifications are blended. If this is not possible, wastes such as cleaning solutions collected and disposed of as hazardous waste according to official regulations. Conditions and measures related to external recovery of waste None. 3. Exposure estimation and reference to its source Workers: see 9.1.2.1 and 9.1.2.3 Environment: see 9.1.2.4 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES See MSDS. 9.1.2

Exposure estimation

The following table summarises process categories (PROCs) assigned to occupational worker exposure for Use 0 Manufacturing. Exposure concentrations were calculated using ECETOC TRA (2009).

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Table 45

SCC Project No. 375-007 12 November 2010

ECETOC TRA occupational exposure scenarios (Use 0 Manufacturing)

Process Category (PROC) PROC 1 PROC 2

Description Use in closed process, no likelihood of exposure Use in closed, continuous process with occasional controlled exposure Use in closed batch process (synthesis or formulation) Use in batch and other process (synthesis) where opportunity for exposure arises Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Production of preparations or articles by tabletting, compression, extrusion, pelletisation

PROC 3 PROC 4 PROC 5

PROC 8a

PROC 8b

PROC 9 PROC 14

Details on exposure calculations are shown in Annex I. 9.1.2.1 Workers exposure 9.1.2.1.1

Acute/Short term exposure

No acute/short term exposure was considered. All exposure periods considered were long term, covering repeated 8 h/day work shifts. 9.1.2.1.2

Long term exposure

The following table shows worst-case long term exposure concentrations to workers (> 4 h/day exposure, full shift), listing exposures for relevant PROCs. Exposure concentrations were calculated using ECETOC TRA (2009, see Annex I). Solid and liquid preparations (preparation concentrations of up to 100 %, TRA > 25 %) were included, as well as indoor and outdoor use (if applicable). Risk minimisation methods include local exhaust ventilation (LEV), respiratory protection (half mask P2 APF 10, 90 % protection) and gloves (90 % protection). Table 46 Routes of exposure

Dermal exposure PROC 1 PROC 2 PROC 3 PROC 4 PROC 4 (outdoors) PROC 5 PROC 5 (outdoors) PROC 8a PROC 8a (outdoors) PROC 8b PROC 9

Long term exposure concentrations to workers (use 0 Manufacturing) Estimated Exposure Concentrations value unit

Measured exposure concentrations value unit

Explanation / source of measured data

0.0343 0.0137 0.0034 0.0685 0.4799 0.1371 0.9599 0.1371 0.1371 0.0342 0.0685

------------

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

------------

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Routes of exposure

PROC 9 (outdoors) PROC 14 Inhalation exposure PROC 1 PROC 2 PROC 3 PROC 4 PROC 4 (outdoors) PROC 5 PROC 5 (outdoors) PROC 8a PROC 8a (outdoors) PROC 8b PROC 9 PROC 9 (outdoors) PROC 14 Combined exposure PROC 1 PROC 2 PROC 3 PROC 4 PROC 4 (outdoors) PROC 5 PROC 5 (outdoors) PROC 8a PROC 8a (outdoors) PROC 8b PROC 9 PROC 9 (outdoors) PROC 14

SCC Project No. 375-007 12 November 2010

Estimated Exposure Concentrations value unit 0.4800 mg/kg/day 0.0342 mg/kg/day 0.001 0.005 0.01 0.05 0.35 0.05 0.35 0.05 0.5 0.025 0.05 0.35 0.01 0.0344 0.0144 0.0048 0.0757 0.5299 0.1442 1.0099 0.1442 0.2085 0.0378 0.0757 0.5300 0.03571

mg/m3 mg/m3 mg/m3 mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

Measured exposure concentrations value unit -----

Explanation / source of measured data

--------------

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

--------------

----------------------------

ECETOC TRA ECETOC TRA

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

Exposure concentrations were estimated for each of the relevant PROCs, with risk minimisation methods applied as outlined in section 9.1.1. PROC 5 (outdoors) revealed highest concentrations for overall exposure with 1.01 mg/kg bw/day. Summary of the long term exposure values: The following table summarizes worst-case long term exposure concentrations to workers for each exposure route. ECETOC TRA calculations for inhalation exposure assumed using a local exhaust ventilation system (LEV, 90 % protection) and wearing a respiratory protective mask (half mask P2 APF 10, 90 % protection). ECETOC TRA calculations for dermal exposures assumed wearing gloves, with a reduction of exposures by 90 % (TNsG, 2007) and the use of a LEV system. The worst-case dermal systemic exposure concentration (mg/kg bw/day) was converted to a local exposure concentration (mg/cm2/day), assuming exposure of two hands and face (480 cm²) for a 70 kg worker (ECHA CSA R14, 2008): 0.9599 mg/kg bw/day * 70 kg / 480 cm2 = 0.1399 mg/cm2/day.

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Table 47

SCC Project No. 375-007 12 November 2010

Summary of long term exposure concentration to workers (Use 0 Manufacturing)

Routes of exposure Dermal local exposure (in mg/cm²) Dermal systemic exposure (in mg/kg bw/day) Inhalation exposure (in mg/m³/8h workday) Combined systemic exposure (in mg/kg bw/day)

Concentrations 0.1399 0.9599 0.5000 1.0099

Justification See calculation ECETOC TRA (Annex I) ECETOC TRA (Annex I) ECETOC TRA (Annex I)

For Use 0 Manufacturing highest exposure concentrations to workers were 0.9599 mg/kg bw/day for systemic dermal exposure, corresponding to 0.1399 mg/cm² dermal local exposure and 0.5000 mg/m³/day for inhalation exposure. Highest combined exposure was 1.0099 mg/kg bw/day. All estimated exposure concentrations were considered worst-case. 9.1.2.2 Consumer use Not relevant for this substance life cycle step. 9.1.2.3 Indirect exposure of humans via the environment (oral) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (see Annex II). Specific ERC release values were installed in the EUSES model. A reduction of 99.9 % emission to air and 99.9 % reduction of emission to wastewater was assumed by e.g. local exhaust ventilation with incineration of filters and waste water treatment. Direct release to soil was considered not applicable. Normally there is no waste, as batches out of specifications are blended. If this is not possible, wastes such as cleaning solutions collected and disposed of as hazardous waste according to official regulations. The following table shows the specific ERC used. Table 48

ECETOC TRA scenario (Use 0 Manufacturing)

Environmental Release Category (ERC) ERC 1: Manufacture of substances

Description Manufacture of organic and inorganic substances in chemical, petrochemical, primary metals and minerals industry including intermediates, monomers using continuous processes or batch processes applying dedicated or multi-purpose equipment, either technically controlled or operated by manual interventions

The following table shows the indirect exposure of humans via the environment. Table 49

Concentration for oral exposure of humans via the environment

ERC

1 1 1 1 1 1 1 1

Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose

Estimated exposure concentrations value unit 2.75E-05 mg/kg/day 9.62E-04 mg/L/day 1.51E-08 mg/kg/day 5.85E-04 mg/kg/day 1.72E-04 mg/kg/day 2.81E-07 mg/kg/day 6.85E-04 mg/m3 1.94E-03 mg/kg/day

Measured exposure concentrations value unit -----------------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 0 Manufacturing calculated total daily concentration for indirect exposure of humans via the environment was 1.94E-03 mg/kg/day. Page 121 of 323 23/119

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The following table shows total daily doses for oral exposure of humans via the environment. Table 50

Total daily dose for oral exposure of humans via the environment

Total daily dose for oral exposure via the environment (mg/kg bw/d) ERC Exposed via local Exposed via local and regional concentration concentration 1 1.94E-03 2.30E-03

Justification

EUSES (v2.1)

For Use 0 Manufacturing the total daily doses for oral exposure of humans via the environment was 1.94E-03 mg/kg/day. The regional total daily concentration was 2.30E-03 mg/kg/day (see section 9.6). 9.1.2.4 Environmental exposure The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (see Annex II). Specific ERC release values were installed in the EUSES model. A reduction of 99.9 % emission to air and 99.9 % reduction of emission to wastewater was assumed by e.g. local exhaust ventilation with incineration of filters and waste water treatment. Direct release to soil was considered not applicable. Normally there is no waste, as batches out of specifications are blended. If this is not possible, wastes such as cleaning solutions collected and disposed of as hazardous waste according to official regulations. The following table shows the specific ERC used. Table 51

ECETOC TRA scenario (Use 0 Manufacturing)

Environmental Release Category (ERC) ERC 1

Description Manufacture of substances

The section below shows tier II exposure assessment results. 9.1.2.4.1 Environmental releases The following table shows estimated releases to relevant compartments of the environment. No measured data was available. Data was calculated by EUSES (v2.1; Annex II). Table 52

Releases to the environment

ERC

Compartments

1 1 1 1 1

Air Waste water Surface water Industrial soil Agricultural soil

Predicted releases 3 kg/day 3.6 kg/day ----

Measured release (kg/d) ------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 0 Manufacturing estimated maximal released amount to air was 3 kg/day and 3.6 kg/day to waste water. The following table shows estimated point source releases and estimated total releases for regional exposures. All relevant compartments were taken into account for exposure estimations. Table 53

Summary of the releases to the environment Page 122 of 323 24/119

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Compartments

1 1 1 1

Air Wastewater Surface water Industrial soil

SCC Project No. 375-007 12 November 2010

Release from point source (local exposure estimation) 3 kg/day 3.6 kg/day ---

Total release for regional exposure estimation

Justification

4.11 kg/day 4.93 kg/day 0 kg/day 0 kg/day

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 0 Manufacturing local release values for air and waste water were 3 kg/day and 3.6 kg/day. Total regional release values to air and waste water were 4.11 kg/day and 4.93 kg/day. There was not direct release to surface water and soil. Release values were used for calculation of environmental compartment predicted environmental concentrations. 9.1.2.4.2

Exposure concentration in sewage treatment plants (STP)

The following table shows estimated concentrations in waste water. Only estimated data calculated by EUSES 2.1 (Annex II) was available. No monitoring data was available. Table 54

Concentrations in sewage (Use 0 Manufacturing)

ERC

Compartments

Measured exposure concentrations

Explanation / source of measured data

Sewage (STP effluent)

Estimated exposure concentrations value unit 1.79 mg/L

1

value --

unit --

1

EUSES (v2.1)

Sewage sludge

1.8

--

--

EUSES (v2.1)

mg/kg

For Use 0 Manufacturing concentrations in sewage effluent was 1.79 mg/L and in sewage sludge 1.8 mg/kg. The following table summarises exposure concentrations in sewage treatment plants. Table 55 ERC 1 1

Predicted Exposure Concentrations (PEC) in sewage (Use 0 Manufacturing

Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw)

Value 1.79 1.8

Justification EUSES (v2.1) EUSES (v2.1)

For Use 0 Manufacturing predicted concentration was 1.79 mg/L, the concentration in dry sewage sludge was 1.8 mg/kg. 9.1.2.4.3

Exposure concentration in aquatic pelagic compartment

The exposure in aquatic pelagic compartment was calculated by EUSES 2.1 (Annex II). The following table shows estimated concentrations for freshwater and marine compartments. No monitoring data was available.

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Table 56

Local concentrations in water (Use 0 Manufacturing)

ERC

Compartments

1

Freshwater

1

Marine water

1

SCC Project No. 375-007 12 November 2010

Intermittent releases to water

Estimated exposure concentrations value 1.79E-03

unit mg/L

Measured local exposure concentrations value unit ---

0.0104 0.0122

mg/L mg/L

---

---

-1.79E-03

-mg/L

---

---

9.66E-04 2.76E-03

mg/L mg/L

---

---

---

---

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available No intermittent releases to water

For Use 0 Manufacturing local and estimated predicted exposure concentrations in freshwater and marine water were 1.79E-03 mg/L, respectively. Regional concentrations in freshwater and marine water were 0.0104 mg/L and 9.66E-04 mg/L. The following table shows summarized PEC-values for aquatic compartments. Table 57

Predicted Exposure Concentrations (PEC) in aquatic compartment (Use 0 Manufacturing)

ERC

Compartments

1 1 1

Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

Local concentration 0.0122 2.76E-03 --

PEC aquatic (local+regional) 0.0104 9.66E-04 --

Justification EUSES (v2.1) EUSES (v2.1) No intermittent releases to water

For Use 0 Manufacturing PEC-values in freshwater and marine water were 0.0104 mg/L and 2.76E-03 mg/L, respectively. PEC-values were used for risk characterisation. 9.1.2.4.4

Exposure concentration in sediments

The following table shows estimated exposure concentrations for sediments calculated by EUSES 2.1 (Annex II). No monitoring data was available.

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Table 58

Local concentrations in sediment (Use 0 Manufacturing)

ERC

Compartments

1

Freshwater sediments

1

SCC Project No. 375-007 12 November 2010

Marine water sediments

Estimated exposure concentrations value --

unit --

Measured local exposure concentrations value unit ---

7.09E-03 0.0104

mg/kg wwt mg/kg wwt

---

---

---

----

---

---

6.69E-04 2.35E-03

mg/kg wwt mg/kg wwt

---

---

--

--

--

--

Explanation / source of measured data

No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available.

For Use 0 Manufacturing PEC-values were 0.0104 mg/kg wwt for freshwater sediments and 2.35E 03 mg/kg wwt for marine water sediments. The following table shows PEC-values for freshwater and marine sediments. Summarized exposure concentrations in aquatic sediments were taken into account for risk characterisation. Table 59

Predicted Exposure Concentrations (PEC) in sediments (Use 0 Manufacturing)

ERC

Compartments

1

Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt)

1

Local concentration --

PEC sediment (local+regional) 0.0104

Justification

--

2.35E-03

EUSES (v2.1)

EUSES (v2.1)

For Use 0 Manufacturing calculated PEC-values in sediments were 0.0104 mg/kg wwt for freshwater sediments and 2.35E-03 mg/kg wwt for marine water sediments, respectively. PECvalues were used for risk characterisation. 9.1.2.4.5

Exposure concentrations in soil and groundwater

The following table shows estimated local concentrations in soil and groundwater calculated by EUSES (Annex 2.1). No monitoring data was available.

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Table 60

SCC Project No. 375-007 12 November 2010

Local concentrations in soil (Use 0 Manufacturing)

ERC

Compartments

1

Agricultural soil averaged

Estimated exposure concentrations

Measured local exposure concentrations value unit ---

value 6.38E-03

unit mg/kg wwt

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

5.13E-03

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

7.09E-03

5.84E-03

1

Grassland averaged

6.01E-03

mg/kg wwt

--

--

1

Groundwater

--

--

--

--

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation for average 30 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES.

For Use 0 Manufacturing estimated concentrations were 6.38E-03 mg/kg wwt, 5.13E-03 mg/kg wwt and for agricultural soil (averaged over 30 and 180 days) and 6.01E-03 mg/kg wwt for grassland. The following table shows PEC-values for soil and groundwater. Table 61

Predicted Exposure Concentrations (PEC) in soil and groundwater (Use 0 Manufacturing)

ERC 1

1 1

Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L)

Local concentration 6.38E-03 5.13E-03

PEC soil/groundwater (local + regional) 7.09E-03 5.84E-03

Justification

6.01E-03 --

6.72E-03 0.0337

EUSES (v2.1) EUSES (v2.1)

EUSES (v2.1) EUSES (v2.1)

For Use 0 Manufacturing calculated PEC-values were 7.09E-03 mg/kg wwt and 5.84E-03 mg/kg for agricultural soil (averaged over 30 days and 180 days), 6.72E-03 mg/kg wwt for grassland and 0.0337 mg/L for groundwater. 9.1.2.4.6

Atmospheric compartment

The following table shows estimated local concentrations in air calculated by EUSES (Annex II).

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Table 62

Local concentrations in air (Use 0 Manufacturing)

ERC

1

Estimated exposure concentrations

During emission

1

Annual average

1

SCC Project No. 375-007 12 November 2010

Annual total deposition

value 8.34E-04

unit mg/m3

Measured local exposure concentrations value unit ---

--

--

--

--

-6.85E-04

-mg/m3

---

---

3.67E-11 6.85E-04

mg/m3 mg/m3

---

---

-0.0246

-mg/m2/ day

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation.

For Use 0 Manufacturing estimated total emission to the atmospheric compartment was 8.34E 04 mg/m3, the annual average was 6.85E-04 mg/m3 with an annual deposition of 0.0246 mg/m2/day. The following table shows PEC-values for the atmospheric compartment. Table 63

Predicted Exposure Concentration (PEC) in air (Use 0 Manufacturing)

ERC 1 1 1

During emission (mg/m3) Annual average (mg/m3) Annual deposition (mg/m2/day)

Local concentration 8.34E-04 6.85E-04 0.0246

PEC air (local+regional) -6.85E-04 --

Justification EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 0 Manufacturing calculated PEC-value for annual average disposition flux was 6.85E-04 mg/m3. 9.1.2.4.7

Exposure concentration relevant for the food chain (Secondary poisoning)

The following table shows exposure concentrations relevant for the food chain (secondary poisoning) calculated by EUSES (Annex II). No monitoring data was available.

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Table 64

Local concentration relevant for secondary poisoning (Use 0 Manufacturing)

ERC

1

Predicted exposure concentrations

Concentration in food of fish eating predator

1

Concentration in food of fish eating top-predator (marine)

1

SCC Project No. 375-007 12 November 2010

Concentration in earthworm

value 0.0157

unit mg/kg wwt mg/L --

0.0104 --

Measured local exposure concentrations value unit -----

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-0.0142

-mg/kg

---

---

-1.57E-03

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil

For Use 0 Manufacturing highest concentrations in food of fish eating top predators were 0.0157 mg/kg wwt in freshwater and 1.57E-03 mg/kg wwt in marine environments, respectively. Concentration in earthworm was 0.0142 mg/kg. The following table shows PEC-values for secondary poisoning. Table 65

Predicted Exposure Concentration in food (PECoral) for secondary poisoning (Use 0 Manufacturing)

ERC 1 1 1

Local concentration PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt)

Justification

0.0157

PEC oral (local+regional) 2.61E-02

1.57E-03

2.54E-03

EUSES (v2.1) calculations

0.0142

1.47E-02

EUSES (v2.1) calculations

EUSES (v2.1) calculations

For Use 0 Manufacturing PECoral-values for top predators were 2.61E-02 mg/kg wwt in freshwater and 2.54E-03 mg/kg wwt in marine environments. Concentrations in earthworms were 1.47E 02 mg/kg. PEC-values were used for risk characterisation.

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9.2

Use 1 Formulation

9.2.1

Exposure scenario

SCC Project No. 375-007 12 November 2010

1. Title Free short title

Formulation

Systematic title based on use descriptor

NA

Processes, tasks activities covered

Formulation, mixing/ blending in batch processes, transfer and packaging ECETOC TRA/EUSES

Assessment Method

2. Operational conditions and risk management measures PROC 1 Use in closed process, no likelihood of exposure Use of the substances in high integrity contained system where little potential exists for exposures, e.g. any sampling via closed loop systems. PROC 2 Use in closed, continuous process with occasional controlled exposure Continuous process but where the design philosophy is not specifically aimed at minimizing Emissions. It is not high integrity and occasional expose will arise e.g. through maintenance, sampling and equipment breakages. PROC 3 Use in closed batch process (synthesis or formulation) Batch manufacture of a chemical or formulation where the predominant handling is in a contained manner, e.g. through enclosed transfers, but where some opportunity for contact with chemicals occurs, e.g. through sampling. PROC 4 Use in batch and other process (synthesis) where opportunity for exposure arises Use in batch manufacture of a chemical where significant op-opportunity for exposure arises, e.g. during charging, sampling or discharge of material, and when the nature of the design is likely to result in exposure. PROC 5 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact). Manufacture or formulation of chemical products or articles using technologies related to mixing and blending of solid or liquid materials, and where the process is in stages and provides the opportunity for significant contact at any stage. PROC 6 Calendaring operations Processing of product matrix. Calendaring at elevated temperature and large exposed surface. PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9 Transfer of substance or preparation into small containers (dedicated filling line, including weighing). Filling lines specifically designed to both capture vapour and aerosol emissions and minimise spillage. PROC 13 Treatment of articles by dipping and pouring Immersion operations. Treatment of articles by dipping, pouring, immersing, soaking, washing out or washing in substances; including cold formation or resin type matrix. Includes handling of treated objects (e.g. after dying, plating,). PROC 14 Production of preparations or articles by tabletting, compression, extrusion, pelletisation ERC 2 Formulation of preparations Mixing and blending of substances into (chemical) preparations in all types of formulating industries, such as paints and do-it-yourself products, pigment paste, fuels, household products Page 129 of 323 31/119

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(cleaning products), lubricants, etc.

Number of sites: 10 % rule applies 2.1 Control of workers exposure Product characteristics Physical state: solid Concentration: up to 100 % Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight packaging: 25 and 50 kg polyethylene bags, 1 t big bag (polypropylene coated textile) Physical state: liquid Concentration: max. 25 % (tier I concentrations up to 100 %) Amounts used NA Frequency and duration of use/exposure Duration [for one worker]: max. 24 hours/day Frequency [for one worker]: max. 360 days/year Human factors not influenced by risk management Respiration volume under conditions of use: 10 m3/8h-day (light activity) Area of potential skin contact under conditions of use: two hands and face (480 cm2) Body weight: 70 kg (worker) Other given operational conditions affecting workers exposure Wearing of protective clothing/personal protective equipment is mandatory. Technical conditions and measures at process level (source) to prevent release Local exhaust ventilation is installed, with exhaust air scrubbers/filters (99 % removal efficiency). Waste water neutralisation (99 % removal efficiency) Technical conditions and measures to control dispersion from source towards the worker Keep container tightly closed in a cool and dry place. Storage away from foodstuffs, reducing agents, heavy-metal compounds, acids and alkalis, protected from humidity and water. Protect from sources of heat. Store not together with inflammable substances. Organisational measures to prevent /limit releases, dispersion and exposure All personnel are trained. Conditions and measures related to personal protection, hygiene and health evaluation General protective and hygienic measures: Keep away from foodstuffs, beverages and food. Take off immediately all contaminated clothing. Clean skin thoroughly immediately after handling the product. Ensure that washing facilities are available in the work place. Avoid contact with the eyes and skin. Do not breathe dust. • Breathing equipment (according to EN 143): In case of brief exposure or low pollution use breathing filter apparatus (half mask P2 APF 10). • Protection of hands (according to EN 374): material: rubber or PVC or other plastic material gloves, glove thickness: 0.5 mm, break through time: >= 8 h • Eye protection (according to EN 166): tightly sealed safety goggles, face protection • Skin and body protection: Page 130 of 323 32/119

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Light weight protective clothing, rubber or neoprene footwear 2.2 Control of environmental exposure Product characteristics Physical state: solid Concentration: up to 100 % Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight packaging: 25 and 50 kg polyethylene bags, 1 t big bag (polypropylene coated textile) Physical state: liquid Concentration: max. 25 % (tier I concentrations up to 100 %) Amounts used Number of sites: 10 % rule applies Annual amount: 40000 t/year Emission days per site: max. 300 days/year Frequency and duration of use Continuous release; 300 days/year Environment factors not influenced by risk management Dilution factor: rivers = 100 (default = 10), coastal zones = 1000 (default = 100) Other given operational conditions affecting environmental exposure There is practically no disposal or run-off into soil, wastewater, drains and sewers. Technical conditions and measures at process level (source) to prevent release Substance release to air or soil can be practically excluded. Formulation occurs to a large extent in closed systems (exception: bagging). Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Local exhaust ventilation is installed, with exhaust air scrubbers/filters (99 % removal efficiency). Waste water is neutralised and detoxified (99 % removal efficiency). Release to soil is practically negligible and emission prevention installed (99 % removal efficiency). Organizational measures to prevent/limit release from site All personnel are trained. Waste water and discharge of solid waste is monitored periodically. Conditions and measures related to municipal sewage treatment plant 2000 m3/day (default) Conditions and measures related to external treatment of waste for disposal Normally there is no waste, as batches out of specifications are blended. If this is not possible, wastes such as cleaning solutions collected and disposed of as hazardous waste according to official regulations. Conditions and measures related to external recovery of waste None. 3. Exposure estimation and reference to its source Workers: see 9.2.2.1 and 9.2.2.3 Environment: see 9.2.2.4 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES See MSDS.

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9.2.2

SCC Project No. 375-007 12 November 2010

Exposure estimation

The following table summarises process categories (PROCs) assigned to occupational worker exposure for Use 1 Formulation. Exposure concentrations were calculated using ECETOC TRA (2009). Table 66

ECETOC TRA occupational exposure scenarios (Use 1 Formulation)

Process Category (PROC) PROC 1 PROC 2

Description Use in closed process, no likelihood of exposure Use in closed, continuous process with occasional controlled exposure Use in closed batch process (synthesis or formulation) Use in batch and other process (synthesis) where opportunity for exposure arises Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) Calendering operations Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Treatment of articles by dipping and pouring Production of preparations or articles by tabletting, compression, extrusion, pelletisation Use as laboratory reagent

PROC 3 PROC 4 PROC 5

PROC 6 PROC 8a

PROC 8b

PROC 9 PROC 13 PROC 14 PROC 15

Details on exposure calculations are shown in Annex I. 9.2.2.1 Workers exposure 9.2.2.1.1

Acute/Short term exposure

No acute/short term exposure was considered. All exposure periods considered were long term, covering a repeated 8 h/day work shifts. 9.2.2.1.2

Long term exposure

The following table shows worst-case long term exposure concentrations to workers (> 4 h/day exposure, full shift), listing exposures for relevant PROCs. Exposure concentrations were calculated using ECETOC TRA (2009, see Annex I). Solid and liquid preparations (preparation concentrations of up to 100 %, TRA > 25 %) were included, as well as indoor and outdoor use (if applicable). Risk minimisation methods include local exhaust ventilation (LEV), respiratory protection (half mask P2 APF 10, 90 % protection) and gloves (90 % protection). Table 67 Routes of exposure

Dermal exposure PROC 1 (solid) PROC 1 (liquid)

Long term exposure concentrations to workers (Use 1 Formulation Use) Estimated Exposure Concentrations value

unit

Measured exposure concentrations value unit

0.0343 0.0343

mg/kg/day mg/kg/day

---

---

Explanation / source of measured data

ECETOC TRA ECETOC TRA Page 132 of 323 34/119

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Routes of exposure

PROC 2 (solid) PROC 2 (liquid) PROC 3 (solid) PROC 3 (liquid) PROC 4 (solid) PROC 4 (liquid) PROC 4 (outdoors, solid) PROC 4 (outdoors, liquid) PROC 5 (solid) PROC 5 (liquid) PROC 5 (outdoors, solid) PROC 5 (outdoors, liquid) PROC 8a (solid) PROC 8a (liquid) PROC 8a (outdoors, solid) PROC 8a (outdoors, liquid) PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 15 (solid) PROC 15 (liquid) Inhalation exposure PROC 1 (solid) PEOC 1 (liquid) PROC 2 (solid) PROC 2 (liquid) PROC 3 (solid) PROC 3 (liquid) PROC 4 (solid) PROC 4 (liquid) PROC 4 (outdoors, solid) PROC 4 (outdoors, liquid) PROC 5 (solid) PROC 5 (liquid) PROC 5 (outdoors, solid) PROC 5 (outdoors, liquid) PROC 8a (solid) PROC 8a (liquid) PROC 8a (outdoors, solid) PROC 8a (outdoors, liquid)

SCC Project No. 375-007 12 November 2010

Estimated Exposure Concentrations value 0.0137 0.0137 0.0034 0.0034 0.0685 0.0685 0.4799 0.4799 0.1371 0.1371 0.9599 0.9599 0.1371 0.1371 0.1371 0.9600 0.0342 0.0205 0.0685 0.0685 0.4800 0.4800 0.1371 0.1371 0.9600 0.9600 0.0342 0.0342 0.0034 0.0034

unit mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

Measured exposure concentrations value unit -------------------------------------------------------------

0.0010 0.0100 0.0050 0.0102 0.0100 0.0102 0.0500 0.0102 0.3500 0.0716 0.0500 0.0102 0.3500 0.0716 0.0500 0.0102 0.5000 0.0716

mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³

-------------------

-------------------

Explanation / source of measured data

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

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Routes of exposure

PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 15 (solid) PROC 15 (liquid) Combined exposure PROC 1 (solid) PEOC 1 (liquid) PROC 2 (solid) PROC 2 (liquid) PROC 3 (solid) PROC 3 (liquid) PROC 4 (solid) PROC 4 (liquid) PROC 4 (outdoors, solid) PROC 4 (outdoors, liquid) PROC 5 (solid) PROC 5 (liquid) PROC 5 (outdoors, solid) PROC 5 (outdoors, liquid) PROC 8a (solid) PROC 8a (liquid) PROC 8a (outdoors, solid) PROC 8a (outdoors, liquid) PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 15 (solid) PROC 15 (liquid)

SCC Project No. 375-007 12 November 2010

Estimated Exposure Concentrations value 0.0250 0.0030 0.0500 0.0102 0.3500 0.0716 0.0100 0.0100 0.0700 0.0716 0.0100 0.0100 0.0050 0.0102

unit mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/kg/day mg/kg/day

0.0344

mg/kg/day

Measured exposure concentrations value unit --------------------------------

0.0357 0.0144 0.0151 0.0048 0.0048 0.0757 0.0700 0.5299 0.4902 0.1442 0.1386 1.0099 0.9702 0.1442 0.1386 0.2085 0.9702 0.0378 0.0210 0.0757 0.0700 0.5300 0.4902 0.1385 0.1386 0.9700 0.9702 0.0357 0.0357 0.0041 0.0048

mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

--------------------------------

--------------------------------

Explanation / source of measured data

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

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SCC Project No. 375-007 12 November 2010

Exposure concentrations were estimated for each of the relevant PROCs, with personal protective equipment applied as outlined above and in section 9.2.4. PROC 5 (outside) when the substance is used in its solid form revealed highest concentrations for overall exposure with 1.0099 mg/kg bw/day. Summary of the long term exposure values: The following table summarizes worst-case long term exposure concentrations to workers for each exposure route. ECETOC TRA calculations for inhalation exposure assumed using a local exhaust ventilation system (LEV, 90 % protection) and wearing a respiratory protective mask (half mask P2 APF 10, 90 % protection). ECETOC TRA calculations for dermal exposures assumed wearing gloves, with a reduction of exposures by 90 % (TNsG, 2007) and the use of a LEV system. The worst-case dermal systemic exposure concentration (mg/kg bw/day) was converted to a local exposure concentration (mg/cm2/day), assuming exposure of two hands and face (480 cm²) for a 70 kg worker (ECHA CSA R14, 2008): 0.9600 mg/kg bw/day * 70 kg / 480 cm2 = 0.14 mg/cm2/day. Table 68

Summary of long term exposure concentration to workers (Use 1 Formulation)

Routes of exposure Dermal local exposure (in mg/cm²) Dermal systemic exposure (in mg/kg bw/day) Inhalation exposure (in mg/m³/8h workday) Combined systemic exposure (in mg/kg bw/day)

Concentrations 0.1400 0.9600 0.5000 1.0099

Justification See calculation ECETOC TRA (Annex I) ECETOC TRA (Annex I) ECETOC TRA (Annex I)

For Use 1 Formulation highest exposure concentrations to workers were 0.9600 mg/kg bw/day for systemic dermal exposure, corresponding to 0.1400 mg/cm² dermal local exposure and 0.5000 mg/m³/day for inhalation exposure. Highest combined exposure was 1.0099 mg/kg bw/day. All estimated exposure concentrations were considered worst-case. 9.2.2.2 Consumer use Not relevant for this substance life cycle step. 9.2.2.3 Indirect exposure of humans via the environment (oral) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (v2.1, see Annex II). Specific ERC release values were installed in the EUSES model. A reduction of 99.0 % emission to air, wastewater and soil was assumed by e.g. local exhaust ventilation with incineration of filters, waste water treatment and release reduction methods. Normally there is no waste, as batches out of specifications are blended. If this is not possible, wastes such as cleaning solutions collected and disposed of as hazardous waste according to official regulations. The following table shows the specific ERC used. Table 69

ECETOC TRA scenario (Use 1 Formulation)

Environmental Release Category (ERC) ERC 2

Description Formulation of mixtures (preparations)

The following table shows the indirect exposure of humans via the environment.

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Table 70

Concentration for oral exposure of humans via the environment

ERC

2 2 2 2 2 2 2 2

SCC Project No. 375-007 12 November 2010

Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose

Estimated exposure concentrations value unit 4.94E-05 mg/kg/day 1.01E-03 mg/L/day 1.62E-08 mg/kg/day 6.31E-04 mg/kg/day 1.8E-04 mg/kg/day 3.02E-07 mg/kg/day 7.62E-04 mg/m3 2.08E-03 mg/kg/day

Measured exposure concentrations value unit -----------------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 1 Formulation calculated total daily concentration for indirect exposure of humans via the environment was 2.08E-03 mg/kg/day. The following table shows total daily doses for oral exposure of humans via the environment. Table 71

Total daily dose for oral exposure of humans via the environment

Total daily dose for oral exposure via the environment (mg/kg bw/d) ERC Exposed via local Exposed via local and regional concentration concentration 2 2.08E-03 2.44E-04

Justification

EUSES (v2.1)

For Use 1 Formulation use the total daily doses for oral exposure of humans via the environment was 2.08E-03 mg/kg/day. The regional total daily concentration was 2.44E-04 mg/kg/day (see section 9.6). 9.2.2.4 Environmental exposure (Use 1 Formulation) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (v2.1, see Annex II). Specific ERC release values were installed in the EUSES model. A reduction of 99.0 % emission to air, wastewater and soil was assumed by e.g. local exhaust ventilation with incineration of filters, waste water treatment and release reduction methods. Normally there is no waste, as batches out of specifications are blended. If this is not possible, wastes such as cleaning solutions collected and disposed of as hazardous waste according to official regulations. The following table shows the specific ERC used. Table 72

ECETOC TRA scenario (Use 1 Formulation)

Environmental Release Category (ERC) ERC 2

Description Formulation of mixtures (preparations)

The section below shows tier II exposure assessment results. 9.2.2.4.1 Environmental releases The following table shows estimated releases to relevant compartments of the environment. No measured data was available. Data was calculated by EUSES (v2.1; Annex II).

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Table 73

SCC Project No. 375-007 12 November 2010

Releases to the environment

ERC

Compartments

2 2 2 2 2

Air Waste water Surface water Industrial soil Agricultural soil

Predicted releases 3.33 kg/day 2.67 kg/day ----

Measured release (kg/d) ------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 1 Formulation use estimated maximal released amounts to air and waste water were 3.33 kg/day and 2.67 kg/day, respectively. The following table shows estimated point source releases and estimated total releases for regional exposures. All relevant compartments were taken into account for exposure estimations. Table 74

Summary of the releases to the environment

ERC

Compartments

2 2 2 2

Air Wastewater Surface water Industrial soil

Release from point source (local exposure estimation) 3.33kg/day 2.67 kg/day ---

Total release for regional exposure estimation

Justification

27.4 kg/day 21.9 kg/day 0 kg/day 0.11 kg/day

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 1 Formulation local release values for air and waste water were 3.33 kg/day and 2.67 kg/day, respectively. Total regional releases to air, waste water and industrial soil were 27.4 kg/day, 21.9 kg/day and 0.11 kg/day, respectively. Release values were used for calculation of environmental compartment predicted environmental concentrations. 9.2.2.4.2

Exposure concentration in sewage treatment plants (STP)

The following table shows estimated concentrations in waste water. Only estimated data calculated by EUSES 2.1 (Annex II) was available. No monitoring data was available. Table 75

Concentrations in sewage (Use 1 Formulation)

ERC

Compartments

Measured exposure concentrations

Explanation / source of measured data

Sewage (STP effluent)

Estimated exposure concentrations value unit 1.33 mg/L

2

value --

unit --

2

EUSES (v2.1)

Sewage sludge

1.33

--

--

EUSES (v2.1)

mg/kg

For Use 1 Formulation concentrations in sewage effluent and sewage sludge were 1.33 mg/L and 1.33 mg/kg, respectively. The following table summarises exposure concentrations in sewage treatment plants. Table 76 ERC 2 2

Predicted Exposure Concentrations (PEC) in sewage (Use 1 Formulation)

Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw)

Value 1.33 1.33

Justification EUSES (v2.1) EUSES (v2.1)

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For Use 1 Formulation predicted effect concentration was 1.33 mg/L and in sewage sludge 1.33 mg/kg. 9.2.2.4.3

Exposure concentration in aquatic pelagic compartment

The exposure in aquatic pelagic compartment was calculated by EUSES 2.1 (Annex II). The following table shows estimated concentrations for freshwater and marine compartments. No monitoring data was available. Table 77

Local concentrations in water (Use 1 Formulation)

ERC

Compartments

2

Freshwater

2

Marine water

2

Intermittent releases to water

Estimated exposure concentrations value 0.0133

unit mg/L

Measured local exposure concentrations value unit ---

0.0104 0.0237

mg/L mg/L

---

---

-1.33E-03

-mg/L

---

---

9.66E-04 2.3E-03

mg/L mg/L

---

---

---

---

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available No intermittent releases to water

For Use 1 Industrial use local estimated predicted exposure concentrations in freshwater and marine water were 0.0133 mg/L and 1.33E-03 mg/L, respectively. Regional estimated predicted exposure concentrations in freshwater and marine water were 0.0104 mg/L and 9.66E-04 mg/L, respectively. The following table shows summarized PEC-values for aquatic compartments. Table 78

Predicted Exposure Concentrations (PEC) in aquatic compartment (Use 1 Formulation)

ERC

Compartments

2 2 2

Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

Local concentration 0.0133 1.33E-03 --

PEC aquatic (local+regional) 0.0237 2.3E-03 --

Justification EUSES (v2.1) EUSES (v2.1) No intermittent releases to water

For Use 1 Formulation PEC-values in freshwater and marine water were 0.0237 mg/L and 2.3E 08 mg/L, respectively. PEC-values were used for risk characterisation. 9.2.2.4.4

Exposure concentration in sediments

The following table shows estimated exposure concentrations for sediments calculated by EUSES 2.1 (Annex II). No monitoring data was available. Page 138 of 323 40/119

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Table 79

Local concentrations in sediment (Use 1 Formulation)

ERC

Compartments

2

Freshwater sediments

2

SCC Project No. 375-007 12 November 2010

Marine water sediments

Estimated exposure concentrations value --

unit --

Measured local exposure concentrations value unit ---

7.09E-03 0.0201

mg/kg wwt mg/kg wwt

---

---

---

----

---

---

6.69E-04 1.96E-03

mg/kg wwt mg/kg wwt

---

---

--

--

--

--

Explanation / source of measured data

No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available.

For Use 1 Formulation PEC-values were 0.0201 mg/kg wwt for freshwater sediments and 6.69E 04 mg/kg wwt for marine water sediments. The following table shows PEC-values for freshwater and marine sediments. Summarized exposure concentrations in aquatic sediments were taken into account for risk characterisation Table 80

Predicted Exposure Concentrations (PEC) in sediments (Use 1 Formulation)

ERC

Compartments

2

Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt)

2

Local concentration --

PEC sediment (local+regional) 0.0201

Justification

--

1.96E-03

EUSES (v2.1)

EUSES (v2.1)

For Use 1 Formulation calculated PEC-values in sediments were 0.0201 mg/kg wwt for freshwater sediments and 1.96E-03 mg/kg wwt for marine water sediments, respectively. PEC-values were used for risk characterisation. 9.2.2.4.5

Exposure concentrations in soil and groundwater

The following table shows estimated local concentrations in soil and groundwater calculated by EUSES (Annex 2.1). No monitoring data was available.

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Table 81

SCC Project No. 375-007 12 November 2010

Table 81 Local concentrations in soil (Use 1 Formulation)

ERC

Compartments

2

Agricultural soil averaged

Estimated exposure concentrations

Measured local exposure concentrations value unit ---

value 6.32E-03

unit mg/kg wwt

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

5.39E-03

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

7.03E-03

6.1E-03

2

Grassland averaged

6.59E-03

mg/kg wwt

--

--

2

Groundwater

--

--

--

--

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation for average 30 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES.

For Use 1 Formulation estimated concentrations were 6.32E-03 mg/kg wwt and 5.39E-03 mg/kg wwt for agricultural soil (averaged over 30 and 180 days) and 6.59E-03 mg/kg wwt for grassland. The following table shows PEC-values for soil and groundwater. Table 82

Predicted Exposure Concentrations (PEC) in soil and groundwater (Use 1 Formulation)

ERC 2

2 2

Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L)

Local concentration 6.32E-03 5.39E-03

PEC soil/groundwater (local + regional) 7.03E-03 6.1E-03

Justification

6.59E-03 --

7.3E-03 0.0352

EUSES (v2.1) EUSES (v2.1)

EUSES (v2.1) EUSES (v2.1)

For Use 1 Formulation ERC 2 calculated PEC-values were 7.03E-03 mg/kg wwt and 6.1E 03 mg/kg wwt for agricultural soil (averaged over 30 days and 180 days), 7.3E-03 mg/kg wwt for grassland and 0.0352 mg/L for groundwater. 9.2.2.4.6

Atmospheric compartment

The following table shows estimated local concentrations in air calculated by EUSES (Annex II).

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Table 83

Local concentrations in air (Use 1 Formulation)

ERC

2

Estimated exposure concentrations

During emission

2

Annual average

2

SCC Project No. 375-007 12 November 2010

Annual total deposition

value 9.27E-04

unit mg/m3

Measured local exposure concentrations value unit ---

--

--

--

--

-7.62E-04

-mg/m3

---

---

3.67E-11 7.62E-03

mg/m3 mg/m3

---

---

-0.0273

-mg/m2/ day

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation.

For Use 1 Formulation estimated total emission to the atmospheric compartment was 9.27E 04 mg/m3, the annual average was 7.62E-04 mg/m3 with an annual deposition of 0.0273 mg/m2/day. The following table shows PEC-values for the atmospheric compartment. Table 84

Predicted Exposure Concentration (PEC) in air (Use 1 Formulation)

ERC 2 2 2

During emission (mg/m3) Annual average (mg/m3) Annual deposition (mg/m2/day)

Local concentration 9.27E-04 7.62E-04 0.0273

PEC air (local+regional) -7.62E-03 --

Justification EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 1 Formulation calculated PEC-value for annual average disposition flux was 7.62E-03 mg/m3. 9.2.2.4.7

Exposure concentration relevant for the food chain (Secondary poisoning)

The following table shows exposure concentrations relevant for the food chain (secondary poisoning) calculated by EUSES (Annex II). No monitoring data was available.

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Table 85

Local concentration relevant for secondary poisoning (Use 1 Formulation)

ERC

2

Predicted exposure concentrations

Concentration in food of fish eating predator

2

Concentration in food of fish eating top-predator (marine)

2

SCC Project No. 375-007 12 November 2010

Concentration in earthworm

value 0.0224

unit mg/kg wwt mg/L --

0.0104 --

Measured local exposure concentrations value unit -----

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-0.0148

-mg/kg

---

---

-1.52E-03

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil

For Use 1 Formulation highest concentrations in food of fish eating top predators were 0.0224 mg/kg wwt in freshwater and 1.52E-03 mg/kg wwt in marine environments, respectively. Concentrations in earthworms were 0.0148 mg/kg. The following table shows PEC-values for secondary poisoning. Table 86

Predicted Exposure Concentration in food (PECoral) for secondary poisoning (Use 1 Formulation)

ERC 2 2 2

Local concentration PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt)

Justification

0.0224

PEC oral (local+regional) 0.0328

1.52E-03

2.49E-03

EUSES (v2.1) calculations

0.0148

2.43E-02

EUSES (v2.1) calculations

EUSES (v2.1) calculations

For Use 1 Formulation PECoral-values for top predators were 0.0328 mg/kg wwt in freshwater and 2.49E-03 mg/kg wwt in marine environments. Concentrations in earthworms were 2.43E-02 mg/kg. PEC-values were used for risk characterisation.

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9.3

Use 2 Industrial use

9.3.1

Exposure scenario

SCC Project No. 375-007 12 November 2010

1. Title Free short title

Industrial Use

Systematic title based on use descriptor

SU 03 Industrial uses End uses of substances in preparations at industrial sites ECETOC TRA/EUSES

Processes, tasks activities covered Assessment Method

2. Operational conditions and risk management measures PROC 1 Use in closed process, no likelihood of exposure Use of the substances in high integrity contained system where little potential exists for exposures, e.g. any sampling via closed loop systems. PROC 2 Use in closed, continuous process with occasional controlled exposure Continuous process but where the design philosophy is not specifically aimed at minimizing Emissions. It is not high integrity and occasional expose will arise e.g. through maintenance, sampling and equipment breakages. PROC 3 Use in closed batch process (synthesis or formulation) Batch manufacture of a chemical or formulation where the predominant handling is in a contained manner, e.g. through enclosed transfers, but where some opportunity for contact with chemicals occurs, e.g. through sampling PROC 4 Use in batch and other process (synthesis) where opportunity for exposure arises Use in batch manufacture of a chemical where significant op-opportunity for exposure arises, e.g. during charging, sampling or discharge of material, and when the nature of the design is likely to result in exposure. PROC 7 Industrial spraying Air dispersive techniques. Spraying for surface coating, adhesives, polishes/cleaners, air care products, sandblasting; Substances can be inhaled as aerosols. The energy of the aero-sol particles may require advanced exposure controls; in case of coating, overspray may lead to waste water and waste. PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9 Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Filling lines specifically designed to both capture vapour and aerosol emissions and minimise spillage. PROC 10 Roller application Low energy spreading of e.g. coatings. Including cleaning of surfaces. Substance can be inhaled as vapours, skin contact can occur through droplets, splashes, working with wipes and handling of treated surfaces. PROC 13 Treatment of articles by dipping and pouring Immersion operations. Treatment of articles by dipping, pouring, immersing, soaking, washing out or washing in substances; including cold formation or resin type matrix. Includes handling of treated objects (e.g. after dying, plating,). PROC 14 Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC 15 Use as laboratory reagent PROC 22 Potentially closed processing operations with minerals/metals at elevated temperature Page 143 of 323 45/119

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PROC 23 Open processing and transfer operations with minerals/metals at elevated temperature ERC 6a Industrial use resulting in manufacture of another substance (use of intermediates) Use of intermediates in primarily the chemical industry using continuous processes or batch processes applying dedicated or multi-purpose equipment, either technically controlled or operated by manual interventions, for the synthesis of other substances. ERC 6b Industrial use of reactive processing aids Industrial use of reactive processing aids in continuous processes or batch processes applying dedicated or multi-purpose equipment, either technically controlled or operated by manual interventions. ERC 6d Industrial use of process regulators for polymerisation processes in production of resins, rubbers, polymers Industrial use of chemicals (cross-linking agents, curing agents) in the production of thermosets and rubbers, polymer processing. Number of sites: 10 % rule applies 2.1 Control of workers exposure Product characteristics Physical state: solid Concentration: up to 100 % Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight packaging: 25 and 50 kg polyethylene bags, 1 t big bag (polypropylene coated textile) Physical state: liquid Concentration: max. 25 % (tier I concentrations up to 100 %) Amounts used NA Frequency and duration of use/exposure Duration [for one worker]: 8 hours/day Frequency [for one worker]: max. 300 days/year Human factors not influenced by risk management Respiration volume under conditions of use: 10 m3/8h-day (light activity) Area of potential skin contact under conditions of use: two hands and face (480 cm2) Body weight: 70 kg (worker) Other given operational conditions affecting workers exposure Wearing of protective clothing/personal protective equipment is mandatory. Technical conditions and measures at process level (source) to prevent release Local exhaust ventilation is installed, with exhaust air scrubbers/filters (min. 90 % removal efficiency). Technical conditions and measures to control dispersion from source towards the worker Keep container tightly closed in a cool and dry place. Storage away from foodstuffs, reducing agents, heavy-metal compounds, acids and alkalis, protected from humidity and water. Protect from sources of heat. Store not together with inflammable substances. Organisational measures to prevent /limit releases, dispersion and exposure All personnel are trained. Conditions and measures related to personal protection, hygiene and health evaluation General protective and hygienic measures: Keep away from foodstuffs, beverages and food. Take off immediately all contaminated clothing. Page 144 of 323 46/119

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Clean skin thoroughly immediately after handling the product. Ensure that washing facilities are available in the work place. Avoid contact with the eyes and skin. Do not breathe dust. • Breathing equipment (according to EN 143): use breathing filter apparatus (half mask P2 APF 10, or P3 APF 20). • Protection of hands (according to EN 374),: material: rubber or PVC or other plastic material gloves, glove thickness: 0.5 mm, break through time: >= 8 h • Eye protection (according to EN 166): tightly sealed safety goggles, face protection • Skin and body protection: Light weight protective clothing, rubber or neoprene footwear 2.2 Control of environmental exposure Product characteristics Physical state: solid Concentration: up to 100 % Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight packaging: 25 and 50 kg polyethylene bags, 1 t big bag (polypropylene coated textile) Physical state: liquid Concentration: max. 25 % (tier I concentrations up to 100 %) Amounts used Fraction of the main local source: 10 % rule applies Annual amount: 40000 t/year Emission days per site: max. 300 days/year Frequency and duration of use Continuous release; 300 days/year Environment factors not influenced by risk management Dilution factor: rivers = 10 (default), coastal zones = 100 (default) Other given operational conditions affecting environmental exposure Substance release to the environment can be practically excluded. The substance is complete consumed in the reaction. No unreacted substance is present in the final product. Technical conditions and measures at process level (source) to prevent release Local exhaust ventilation is installed, with ERC 6a min. 99 % emission reduction ERC 6b min. 90 % emission reduction ERC 6d min. 99.9 % emission reduction The substance is completely consumed during use and therefore there is practically no release to wastewater and soil. Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Substance release can be practically excluded. The substance is completely consumed during chemical reaction. No unreacted substance remains in the final product. Organizational measures to prevent/limit release from site All personnel are trained. Conditions and measures related to municipal sewage treatment plant 2000 m3/day (default) Conditions and measures related to external treatment of waste for disposal Page 145 of 323 47/119

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Normally there is no waste. No unreacted persulfate remains. Conditions and measures related to external recovery of waste None 3. Exposure estimation and reference to its source Workers: see 9.3.2.1 and 9.3.2.3 Environment: see 9.3.2.4 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES See MSDS. 9.3.2

Exposure estimation

The following table summarises process categories (PROCs) assigned to occupational worker exposure for Use 2 Industrial use. Exposure concentrations were calculated using ECETOC TRA (2009). Table 87

ECETOC TRA occupational exposure scenarios (Use 2 Industrial use)

Process Category (PROC) PROC 1 PROC 2 PROC 3 PROC 4 PROC 5

PROC 6 PROC 7 PROC 8a

PROC 8b

PROC 9 PROC 10 PROC 13 PROC 14 PROC 22 PROC 23

Description Use in closed process, no likelihood of exposure Use in closed, continuous process with occasional controlled exposure Use in closed batch process (synthesis or formulation) Use in batch and other process (synthesis) where opportunity for exposure arises Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) Calendering operations Industrial spraying Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Roller application or brushing Treatment of articles by dipping and pouring Production of preparations or articles by tabletting, compression, extrusion, pelletisation Potentially closed processing operations with minerals/metals at elevated temperature Open processing and transfer operations with minerals/metals at elevated temperature

Details on exposure calculations are shown in Annex I. 9.3.2.1 Workers exposure 9.3.2.1.1

Acute/Short term exposure

No acute/short term exposure was considered. All exposure periods considered were long term, covering a repeated 8 h/day work shifts.

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9.3.2.1.2

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Long term exposure

The following table shows worst-case long term exposure concentrations to workers (> 4 h/day exposure, full shift), listing exposures for relevant PROCs. Exposure concentrations were calculated using ECETOC TRA (2009, see Annex I). Solid and liquid preparations (preparation concentrations of up to 100 %, TRA > 25 %) were included, as well as indoor and outdoor use (if applicable). Risk minimisation methods include local exhaust ventilation (LEV), respiratory protection (half mask P2 APF 10, 90 % protection) and gloves (90 % protection). Table 88

Long term exposure concentrations to workers (Use 2 Industrial use)

Routes of exposure

Dermal exposure PROC 1 (solid) PEOC 1 (liquid) PROC 2 (solid) PROC 2 (liquid) PROC 3 (solid) PROC 3 (liquid) PROC 4 (solid) PROC 4 (liquid) PROC 4 (outdoors, solid) PROC 4 (outdoors, liquid) PROC 5 (solid) PROC 5 (liquid) PROC 5 (outdoors, solid) PROC 5 (outdoors, liquid) PROC 8a (solid) PROC 8a (liquid) PROC 8a (outdoors, solid) PROC 8a (outdoors, liquid) PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 10 (liquid) PROC 10 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 22 (solid) PROC 23 (solid) PROC 23 (outdoors, solid) Inhalation exposure PROC 1 (solid) PEOC 1 (liquid)

Estimated Exposure Concentrations value

unit

Measured exposure concentrations value unit

Explanation / source of measured data

0.0343 0.0343 0.0137 0.0137 0.0034 0.0034 0.0685 0.0685 0.4799 0.4799 0.1371 0.1371 0.9599 0.9599 0.1371 0.1371 0.1371 0.9600 0.0342 0.0205 0.0685 0.0685 0.4800 0.4800 0.2742 1.9200 0.1371 0.1371 0.9600 0.9600 0.0342 0.0342 0.0282 0.0141 0.0990

mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

------------------------------------

------------------------------------

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

0.0010 0.0100

mg/m³ mg/m³

---

---

ECETOC TRA ECETOC TRA Page 147 of 323 49/119

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PROC 2 (solid) PROC 2 (liquid) PROC 3 (solid) PROC 3 (liquid) PROC 4 (solid) PROC 4 (liquid) PROC 4 (outdoors, solid) PROC 4 (outdoors, liquid) PROC 5 (solid) PROC 5 (liquid) PROC 5 (outdoors, solid) PROC 5 (outdoors, liquid) PROC 8a (solid) PROC 8a (liquid) PROC 8a (outdoors, solid) PROC 8a (outdoors, liquid) PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 10 (liquid) PROC 10 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 22 (solid) PROC 23 (solid) PROC 23 (outdoors, solid) Combined exposure PROC 1 (solid) PEOC 1 (liquid) PROC 2 (solid) PROC 2 (liquid) PROC 3 (solid) PROC 3 (liquid) PROC 4 (solid) PROC 4 (liquid) PROC 4 (outdoors, solid) PROC 4 (outdoors, liquid) PROC 5 (solid) PROC 5 (liquid) PROC 5 (outdoors, solid) PROC 5 (outdoors, liquid) PROC 8a (solid)

SCC Project No. 375-007 12 November 2010

Estimated Exposure Concentrations value 0.0050 0.0102 0.0100 0.0102 0.0500 0.0102 0.3500 0.0716 0.0500 0.0102 0.3500 0.0716 0.0500 0.0102 0.5000 0.0716 0.0250 0.0030 0.0500 0.0102 0.3500 0.0716 0.0051 0.0358 0.0100 0.0100 0.0700 0.0716 0.0100 0.0100 0.0300 0.0300 0.2100

unit mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/kg/day mg/kg/day mg/kg/day

0.0344

mg/kg/day

Measured exposure concentrations value unit ----------------------------------------------------------------------

0.0357 0.0144 0.0151 0.0048 0.0048 0.0757 0.0700 0.5299 0.4902 0.1442 0.1386 1.0099 0.9702 0.1442

mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

---------------

---------------

Explanation / source of measured data

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

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Estimated Exposure Concentrations

PROC 8a (liquid) PROC 8a (outdoors, solid) PROC 8a (outdoors, liquid) PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 10 (liquid) PROC 10 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 22 (solid) PROC 23 (solid) PROC 23 (outdoors, solid)

value 0.1386 0.2085 0.9702 0.0378 0.0210 0.0757 0.0700 0.5300 0.4902 0.2750 1.9251 0.1385 0.1386 0.9700 0.9702 0.0357 0.0357 0.0325 0.0184 0.1290

unit mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

Measured exposure concentrations value unit -----------------------------------------

Explanation / source of measured data

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

Exposure concentrations were estimated for each of the relevant PROCs, with personal protective equipment applied as outlined above and in section 9.2.8. PROC 10 (outdoor) with substance in liquid form revealed highest concentrations for overall exposure with 1.9251 mg/kg bw/day. Summary of the long term exposure values. The following table summarizes worst-case long term exposure concentrations to workers for each exposure route calculated by ECETOC TRA. ECETOC TRA calculations for inhalation exposure assumed using a local exhaust ventilation system (LEV, 90 % protection) and wearing a respiratory protective mask (half mask P2 APF 10, 90 % protection or P3 APF 20, 95 % protection). ECETOC TRA calculations for dermal exposures assumed wearing gloves, with a reduction of exposures by 90 % (TNsG, 2007) and the use of a LEV system. The worst-case dermal systemic exposure concentration (mg/kg bw/day) was converted to a local exposure concentration (mg/cm2/day), assuming exposure of two hands and face (480 cm²) for a 70 kg worker (ECHA CSA R14, 2008): 1.920 mg/kg bw/day * 70 kg / 480 cm2 = 0.28 mg/cm2/day. Table 89

Summary of ECETOC TRA long term exposure concentration to workers (Use 2 Industrial use)

Routes of exposure Dermal local exposure (in mg/cm²day) Dermal systemic exposure (in mg/kg bw/day) Inhalation exposure (in mg/m³/8h work day) Combined systemic exposure (in mg/kg bw/day)

Concentrations 0.2800 1.9200 0.5000 1.9251

Justification See calculation ECETOC TRA (Annex I) ECETOC TRA (Annex I) ECETOC TRA (Annex I)

For Use 2 Industrial use highest exposure concentrations to workers were 1.92 mg/kg bw/day for systemic dermal exposure, corresponding to 0.28 mg/cm² dermal local exposure and 0.50 mg/m³/day for inhalation exposure. Highest combined exposure was 1.9251 mg/kg bw/day. All estimated exposure concentrations were considered worst-case. Page 149 of 323 51/119

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Exposure for industrial spraying application (PROC 7) was assessed in a tier II analysis. For tier I see ECETOC calculations in Annex I. Tier II assessments were calculated using ConsExpo (v4.1, RIVM, 2005). The scenario was selected from the “painting products” product database including product category “spray painting – pneumatic spraying”. Default parameters were taken from RIVM ConsExpo Paint Products Fact Sheet (2007) and adjusted for industrial applications. All calculations reflect a worst-case tier II approach. For the PROC 7 tier II scenario parameters were adjusted for industrial, including setting the exposure frequency to 300 days a year, increasing the body weight to 70 kg (worker), increasing the inhalation rate to light exercise and extending spray and exposure duration to full shift, i.e. 360 min. spraying and 480 min. exposure (following ECB Data Base on Human Exposure for PT 7 and PT10, 2007). The weight fraction of the compound was set to 0.25. Uptake fractions were set to 0.1, reflecting the worst-case scenario with appropriate risk minimisation methods applied. Workers dermal exposure area was set to 1500 cm² for forearms and hands (ECETOC TRA Targeted Risk Assessment, Technical Report no. 93). Defaults and adjusted parameters for industrial spraying are shown in the following: General Exposure Data exposure frequency body weight Inhalation model: Exposure to spray weight fraction compound exposure duration room volume ventilation rate mass generation rate spray duration airborn fraction weight fraction non-volatile density non-volatile room height inhalation cut-off diameter non-respirable uptake fraction Spraying away from exposed person Uptake model: Fraction uptake fraction inhalation rate

300 70

1/year kilogram

0.25 480 34 1.5 0.5 360 0.2 0.5 1.5 2.25 15 0

fraction minute m3 1/hr g/sec minute fraction fraction g/cm3 meter micrometer fraction

0.1 36.4

Dermal model: Direct dermal contact with product : constant rate weight fraction compound 0.25 exposed area 1.5E3 contact rate 110 release duration 798 Uptake model: fraction uptake fraction 0.1

fraction m3/day

fraction cm2 mg/min second fraction

Output Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose :

2.54 0.845 0.694 0.0439

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inhalation chronic (internal) dose :

0.0361

mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.244 5.23 0.523 0.429

mg/cm2 mg/kg mg/kg mg/kg/day

Oral non-respirable: point estimates oral external dose : oral acute (internal) dose : oral chronic (internal) dose :

0 mg/kg 0 mg/kg 0 mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

8.63 0.566 0.465

mg/kg mg/kg mg/kg/day

For industrial spraying (PROC 7) calculated by ConsExpo the relevant long term exposure concentrations for dermal exposure, inhalation exposure and combined systemic exposure were 0.429 mg/kg/day, 0.694 mg/m³/day and 0.465 mg/kg/day, respectively. The following table summarizes worst-case long term exposure concentrations to workers for each exposure routes, as calculated for each of the relevant applications using ECETOC TRA and ConsExpo. Table 90

Summary of overall long term exposure concentration to workers (Use 2 Industrial use)

Routes of exposure Dermal local exposure (in mg/cm²/day) Dermal systemic exposure (in mg/kg bw/day) Inhalation exposure (in mg/m³/8h work day) Combined systemic exposure (in mg/kg bw/day)

Concentrations 0.5190 3.5600 0.6940 1.9251

Justification See calculation ConsExpo ECETOC TRA ConsExpo

For use 2 Industrial use highest exposure values are for dermal local exposure 0.5190 mg/cm²/day, for dermal systemic exposure 3.5600 mg/kg bw/day, for inhalation exposure 0.6940 mg/m³/day and for combined systemic exposure 1.9251 mg/kg bw/day. 9.3.2.2 Consumer use Not relevant for this substance life cycle step. 9.3.2.3 Indirect exposure of humans via the environment (oral) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (v2.1, see Annex II). Specific ERC release values were installed in the EUSES model. Risk minimisation methods leading to emission reduction from of 99.0 % (ERC 6a), 90.0 % (ERC 6b) and 99.9 % (ERC 6d) in air were included. As the substance is completely consumed during use, there is practically no release to wastewater and soil. There is practically no waste, as no unreacted substance remains after use. The following table shows the specific ERC used.

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Table 91

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ECETOC TRA scenario (Use 2 Industrial use)

Environmental Release Category (ERC) ERC 6a ERC 6b ERC 6d

Description Industrial use resulting in manufacture of another substance (use of intermediates) Industrial use of reactive processing aids Industrial use of process regulators for polymerisation processes in production of resins, rubbers, polymers

The following table shows the indirect exposure of humans via the environment. Table 92

Concentration for oral exposure of humans via the environment

ERC

6a 6a 6a 6a 6a 6a 6a 6a 6b 6b 6b 6b 6b 6b 6b 6b 6d 6d 6d 6d 6d 6d 6d 6d

Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose

Estimated exposure concentrations value unit 2.41E-05 mg/kg/day 1.69E-03 mg/L/day 2.96E-08 mg/kg/day 1.17E-03 mg/kg/day 3.02E-04 mg/kg/day 5.53E-07 mg/kg/day 1.52E-03 mg/m3 3.62E-03 mg/kg/day 2.41E-05 mg/kg/day 4.31E-04 mg/L/day 6.92E-09 mg/kg/day 2.61E-04 mg/kg/day 7.7E-05 mg/kg/day 1.29E-07 mg/kg/day 3.05E-04 mg/m3 8.81E-04 mg/kg/day 2.41E-05 mg/kg/day 1.22E-03 mg/L/day 2.11E-08 mg/kg/day 8.27E-04 mg/kg/day 2.17E-04 mg/kg/day 3.94E-07 mg/kg/day 3 1.07E-03 mg/m 2.59E-03 mg/kg/day

Measured exposure concentrations value unit -------------------------------------------------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 2 Industrial use ERC 6a, ERC 6c and ERC 6d calculated total daily concentrations for indirect exposure of humans via the environment were 3.62E-03 mg/kg/day, 8.81E-04 mg/kg/day, and 2.59E-03 mg/kg/day, respectively. The following table shows total daily doses for oral exposure of humans via the environment. Table 93

Total daily dose for oral exposure of humans via the environment

Total daily dose for oral exposure via the environment (mg/kg bw/d) ERC Exposed via local Exposed via local and regional concentration concentration 6a 3.62E-03 3.98E-03 6b 8.81E-04 1.24E-03 6d 2.59E-03 2.95E-03

Justification

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

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For Use 2 Industrial use ERC 6a, ERC 6b and ERC 6d the total daily doses for oral exposure of humans via the environment were 3.62E-03 mg/kg/day, 8.81E-04 mg/kg/day and 2.59E-03 mg/kg/day, respectively. The regional total daily concentration was 3.61E 04 mg/kg/day (see section 9.6). 9.3.2.4 Environmental exposure (Use 2 Industrial use) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (v2.1, see Annex II). Specific ERC release values were installed in the EUSES model. Risk minimisation methods leading to emission reduction from of 99.0 % (ERC 6a), 90.0 % (ERC 6b) and 99.9 % (ERC 6d) in air were included. As the substance is completely consumed during use, there is practically no release to wastewater and soil. There is practically no waste, as no unreacted substance remains after use. The following table shows the specific ERC used. Table 94

ECETOC TRA scenario (Use 2 Industrial use)

Environmental Release Category (ERC) ERC 6a ERC 6b ERC 6d

Description Industrial use resulting in manufacture of another substance (use of intermediates) Industrial use of reactive processing aids Industrial use of process regulators for polymerisation processes in production of resins, rubbers, polymers

The section below shows tier II exposure assessment results. 9.3.2.4.1 Environmental releases The following table shows estimated releases to relevant compartments of the environment. No measured data was available. Data was calculated by EUSES (v2.1; Annex II). Table 95

Releases to the environment (local)

ERC

Compartments

6a 6a 6a 6a 6a 6b 6b 6b 6b 6b 6d 6d 6d 6d 6d

Air Waste water Surface water Industrial soil Agricultural soil Air Waste water Surface water Industrial soil Agricultural soil Air Waste water Surface water Industrial soil Agricultural soil

Predicted releases 6.67 kg/day 0 kg/day ---1.33 kg/day 0 kg/day ---4.67 kg/day 0 kg/day ----

Measured release (kg/d) ----------------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 2 Industrial use ERC 6a, ERC 6b and ERC 6d estimated maximal released amounts to air were 6.67 kg/day, 1.33 kg/day and 4.67 kg/day, respectively. There was no release to water and soil. Page 153 of 323 55/119

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The following table shows estimated point source releases and estimated total releases for regional exposures. All relevant compartments were taken into account for exposure estimations. Table 96

Summary of the releases to the environment

ERC

Compartments

6a 6a 6a 6a 6b 6b 6b 6b 6d 6d 6d 6d

Air Wastewater Surface water Industrial soil Air Wastewater Surface water Industrial soil Air Wastewater Surface water Industrial soil

Release from point source (local exposure estimation) 6.67 kg/day 0 kg/day --1.33 kg/day 0 kg/day --4.67 kg/day 0 kg/day ---

Total release for regional exposure estimation

Justification

54.8 day 0 kg/day 0 kg/day 0 kg/day 11 day 0 kg/day 0 kg/day 0 kg/day 38.4 kg/day 0 kg/day 0 kg/day 0 kg/day

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 2 Industrial use local release values for ERC 6a, ERC 6b and ERC 6d were 6.67 kg/day, 1.33 kg/day and 4.67 kg/day to air for local releases, respectively. Total regional releases were 54.8 kg/day, 11 kg/day and 38.4 kg/day, respectively Release values were used for calculation of environmental compartment predicted environmental concentrations. 9.3.2.4.2

Exposure concentration in sewage treatment plants (STP)

The following table shows estimated concentrations in waste water. Only estimated data calculated by EUSES 2.1 (Annex II) was available. No monitoring data was available. During use the product is completely consumed and therefore there is practically no release to wastewater and soil. Table 97

Concentrations in sewage (Use 2 Industrial use)

ERC

Compartments

Measured exposure concentrations

Explanation / source of measured data

Sewage (STP effluent)

Estimated exposure concentrations value unit 0 mg/L

6a

value --

unit --

EUSES (v2.1)

6a

Sewage sludge

0

mg/kg

--

--

EUSES (v2.1)

6b

Sewage (STP effluent)

0

mg/L

--

--

EUSES (v2.1)

6b

Sewage sludge

0

mg/kg

--

--

EUSES (v2.1)

6d

Sewage (STP effluent)

0

mg/L

--

--

EUSES (v2.1)

6d

Sewage sludge

0

mg/kg

--

--

EUSES (v2.1)

For Use 2 Industrial use ERC 6a, ERC 6b and ERC 6d concentrations in sewage effluent and sewage sludge were zero (0). The following table summarises exposure concentrations in sewage treatment plants.

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Table 98 ERC 6a 6a 6b 6b 6d 6d

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Predicted Exposure Concentrations (PEC) in sewage (Use 2 Industrial use)

Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw) Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw) Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw)

Value 0 0 0 0 0 0

Justification EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 2 Industrial use no release to STP was expected, as the product is completely consumed during use and therefore there is practically no release to wastewater and soil. 9.3.2.4.3

Exposure concentration in aquatic pelagic compartment

The exposure in aquatic pelagic compartment was calculated by EUSES 2.1 (Annex II). The following table shows estimated concentrations for freshwater and marine compartments. No monitoring data was available. Table 99

Local concentrations in water (Use 2 Industrial use)

ERC

Compartments

6a

Freshwater

6a

6a 6b

6b

Marine water

Intermittent releases to water Freshwater

Marine water

Estimated exposure concentrations value 0

unit mg/L

Measured local exposure concentrations value unit ---

0.0104 0.0104

mg/L mg/L

---

---

-0

-mg/L

---

---

9.66E-04 9.66E-04

mg/L mg/L

---

---

---

---

---

---

0

mg/L

--

--

0.0104 0.0104

mg/L mg/L

---

---

-0

-mg/L

---

---

9.66E-04 9.66E-04

mg/L mg/L

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available No intermittent releases to water Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + Page 155 of 323 57/119

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ERC

6b

Compartments

Intermittent releases to water Freshwater

6d

6d

Marine water

6d

Intermittent releases to water

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Estimated exposure concentrations value

unit

Measured local exposure concentrations value unit

---

---

---

---

0

mg/L

--

--

0.0104 0.0104

mg/L mg/L

---

---

-0

-mg/L

---

---

9.66E-04 9.66E-04

mg/L mg/L

---

---

---

---

---

---

Explanation / source of measured data

regional concentration No monitoring data available No intermittent releases to water Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available No intermittent releases to water

For Use 2 Industrial use ERC 6a, ERC 6b and ERC 6d local and regional estimated predicted exposure concentrations in freshwater and marine water were 0.0104 mg/L and 9.66E 04 mg/L, respectively. The following table shows summarized PEC-values for aquatic compartments. Table 100 ERC

Compartments

6a 6a 6a

Predicted Exposure Concentrations (PEC) in aquatic compartment (Use 2 Industrial use)

Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

Local concentration 0 0 --

PEC aquatic (local+regional) 0.0104 9.66E-04 --

6b 6b 6b

Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

0 0 --

0.0104 9.66E-04 --

6d 6d 6d

Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

0 0 --

0.0104 9.66E-04 --

Justification EUSES (v2.1) EUSES (v2.1) No intermittent releases to water EUSES (v2.1) EUSES (v2.1) No intermittent releases to water EUSES (v2.1) EUSES (v2.1) No intermittent releases to water

For Use 2 Industrial use all PEC-values in freshwater and marine water were 0.0104 mg/L and 9.66E-04 mg/L, respectively. PEC-values were used for risk characterisation.

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Exposure concentration in sediments

The following table shows estimated exposure concentrations for sediments calculated by EUSES 2.1 (Annex II). No monitoring data was available. Table 101

Local concentrations in sediment (Use 2 Industrial use)

ERC

Compartments

6a

Freshwater sediments

6a

6b

6b

6d

6d

Marine water sediments

Freshwater sediments

Marine water sediments

Freshwater sediments

Marine water sediments

Estimated exposure concentrations value --

unit --

Measured local exposure concentrations value unit ---

7.09E-03 8.82E-03

mg/kg wwt mg/kg wwt

---

---

---

---

---

---

6.69E-04 8.22E-04

mg/kg wwt mg/kg wwt

---

---

---

---

---

---

7.09E-03 8.82E-03

mg/kg wwt mg/kg wwt

---

---

---

----

---

---

6.69E-04 8.22E-04

mg/kg wwt mg/kg wwt

---

---

---

---

---

---

7.09E-03 8.82E-03

mg/kg wwt mg/kg wwt

---

---

---

---

---

---

6.69E-04 8.22E-04

mg/kg wwt mg/kg wwt

---

---

--

--

--

--

Explanation / source of measured data

No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available.

For Use 2 Industrial use ERC 6a, ERC 6b and ERC 6d PEC-values were 8.82E-03 mg/kg wwt for freshwater sediments and 8.22E-04 mg/kg wwt for marine water sediments, respectively. Page 157 of 323 59/119

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The following table shows PEC-values for freshwater and marine sediments. Summarized exposure concentrations in aquatic sediments were taken into account for risk characterisation Table 102

Predicted Exposure Concentrations (PEC) in sediments (Use 2 Industrial use

ERC

Compartments

6a

Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt) Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt) Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt)

6a 6b 6b 6d 6d

Local concentration --

PEC sediment (local+regional) 8.82E-03

Justification

--

8.22E-04

EUSES (v2.1)

--

8.82E-03

EUSES (v2.1)

--

8.22E-04

EUSES (v2.1)

--

8.82E-03

EUSES (v2.1)

--

8.22E-04

EUSES (v2.1)

EUSES (v2.1)

For Use 2 Industrial use ERC 6a, ERC 6b and ERC 6d calculated PEC-values in sediments were 8.82E 03 mg/kg wwt for freshwater sediments and 8.22E-04 mg/kg wwt for marine water sediments, respectively. PEC-values were used for risk characterisation. 9.3.2.4.5

Exposure concentrations in soil and groundwater

The following table shows estimated local concentrations in soil and groundwater calculated by EUSES (Annex 2.1). No monitoring data was available. Table 103

Local concentrations in soil (Use 2 Industrial use)

ERC

Compartments

6a

Agricultural soil averaged

Estimated exposure concentrations

Measured local exposure concentrations value unit ---

value 9.55E-03

unit mg/kg wwt

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

9.55E-03

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

0.0103

0.0103

6a

Grassland averaged

0.0128

mg/kg wwt

--

--

6a

Groundwater

--

--

--

--

6b

Agricultural soil averaged

1.91E-03

mg/kg wwt

--

--

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation for average 30 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES. Estimated local exposure concentration based on EUSES calculation for average 30 days. Page 158 of 323 60/119

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ERC

Compartments

SCC Project No. 375-007 12 November 2010

Estimated exposure concentrations value 5.26E-04 2.62E-03

unit mg/kg wwt mg/kg wwt

Measured local exposure concentrations value unit ---

Explanation / source of measured data

--

--

Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration

1.91E-03

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

2.62E-03

6b

Grassland averaged

2.57E-03

mg/kg wwt

--

--

6b

Groundwater

--

--

--

--

6d

Agricultural soil averaged

6.68E-03

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

6.68E-03

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

7.39E-03

7.39E-03

6d

Grassland averaged

8.99E-03

mg/kg wwt

--

--

6d

Groundwater

--

--

--

--

Regional concentration

Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES. Estimated local exposure concentration based on EUSES calculation for average 30 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES.

For Use 2 Industrial use ERC 6a estimated concentrations were 9.55E-03 mg/kg wwt for agricultural soil averaged over 30 days and 180 days and 0.0128 mg/kg wwt for grassland. For ERC 6b concentrations were 1.91E-03 mg/kg wwt for agricultural soil (averaged over 30 and 180 days) and 2.57E-03 mg/kg wwt for grassland, respectively. For ERC 6d concentrations were 6.68E-03 mg/kg wwt for agricultural soil (averaged 30 and 180 days) and 8.99E-03 mg/kg for grassland. The following table shows PEC-values for soil and groundwater. Table 104

Predicted Exposure Concentrations (PEC) in soil and groundwater (Use 2 Industrial use) Page 159 of 323 61/119

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ERC 6a

Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L) Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L) Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L)

6a 6a 6b

6b 6b 6d

6d 6d

Local concentration 9.55E-03 9.55E-03

PEC soil/groundwater (local + regional) 0.0103 0.0103

Justification

0.0128 -1.91E-03 1.91E-03

0.0135 0.0591 2.62E-03 2.62E-03

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

2.57E-03 -6.68E-03 6.68E-03

3.28E-03 0.0151 7.39E-03 7.39E-03

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

8.99E-03 --

9.7E-03 0.0426

EUSES (v2.1) EUSES (v2.1)

EUSES (v2.1) EUSES (v2.1)

For Use 2 Industrial use ERC 6a calculated PEC-values were 0.0103 mg/kg wwt for agricultural soil averaged over 30 days and 180 days, 0.0135 mg/kg wwt for grassland and 0.0591 mg/L for groundwater, respectively. For ERC 6b calculated PEC-values were 2.62E-03 mg/kg wwt for agricultural soil averaged over 30 days and 180 days, 3.28E-03 mg/kg wwt for grassland and 0.0151 mg/L for groundwater, respectively. For ERC 6d calculated PEC-values were 7.39E 03 mg/kg wwt agricultural soil (averaged over 30 and 180 days), 9.7E-03 for grassland and 0.0426 mg/L for groundwater. PEC-values were used for risk characterisation. 9.3.2.4.6

Atmospheric compartment

The following table shows estimated local concentrations in air calculated by EUSES (v2.1, Annex II). Table 105

Local concentrations in air (Use 2 Industrial use)

ERC

6a

6a

6a 6b

6b

Estimated exposure concentrations

During emission

Annual average

Annual total deposition During emission

Annual average

value 1.85E-03

unit mg/m3

Measured local exposure concentrations value unit ---

--

--

--

--

-1.52E-03

-3 mg/m

---

---

3.67E-11 1.52E-03

mg/m mg/m3

3

---

---

-0.546

---

---

3.71E-04

-mg/m2/ day mg/m3

--

--

--

--

--

--

-3.05E-03

-3 mg/m

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration

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ERC

6b

Estimated exposure concentrations

Annual total deposition During emission

6d

6d

Annual average

6d

SCC Project No. 375-007 12 November 2010

Annual total deposition

value

unit

Measured local exposure concentrations value unit

3.67E-11 3.05E-04

mg/m3 mg/m3

---

---

-0.0109

---

---

1.3E-03

-mg/m2/ day mg/m3

--

--

--

--

--

--

-1.07E-03

-mg/m3

---

---

3.67E-11 1.07E-03

mg/m3 mg/m3

---

---

-0.0382

-mg/m2/ day

---

---

Explanation / source of measured data

based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation.

For Use 2 Industrial use ERC 6a estimated total emission to the atmospheric compartment was 1.85E-03 mg/m3, the annual average was 1.52E-03 mg/m3 with an annual deposition of 0.546 mg/m2/day. For ERC 6b estimated total emission to the atmospheric compartment was 3.71E-04 mg/m3, the annual average was 3.05E-03 mg/m3 with an annual deposition of 0.0109 mg/m2/day. For ERC 6d estimated total emission to the atmospheric compartment was 1.3E-03 mg/m3, the annual average was 1.07E-03 mg/m3 with an annual deposition of 0.0382 mg/m2/day. The following table shows PEC-values for the atmospheric compartment. Table 106

Predicted Exposure Concentration (PEC) in air (Use 2 Industrial use)

ERC 6a 6a 6a 6b 6b 6b 6d 6d 6d

3

During emission (mg/m ) Annual average (mg/m3) Annual deposition (mg/m2/day) During emission (mg/m3) Annual average (mg/m3) Annual deposition (mg/m2/day) 3 During emission (mg/m ) 3 Annual average (mg/m ) Annual deposition 2 (mg/m /day)

Local concentration 1.85E-03 1.52E-03 0.546

PEC air (local + regional) -1.52E-03 --

Justification

3.71E-04 3.05E-03 0.0109

-3.05E-04 --

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

1.3E-03 1.07E-03 0.0382

-1.07E-03 --

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 2 Industrial use ERC 6a, 6b and 6d calculated PEC-values for annual average were 1.52E-03 mg/m3, 3.05E-04 mg/m3, 4.83E-03 mg/m3 and 1.07E-03 mg/m3. PEC-values were used for risk characterisation. 9.3.2.4.7 Exposure concentration relevant for the food chain (Secondary poisoning)

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The following table shows exposure concentrations relevant for the food chain (secondary poisoning) calculated by EUSES (v2.1, Annex II). No monitoring data was available. Table 107

Local concentration relevant for secondary poisoning (Use 2 Industrial use)

ERC

6a

6a

6a 6b

6b

6b 6d

6d

6d

Predicted exposure concentrations

Concentration in food of fish eating predator

Concentration in food of fish eating top-predator (marine)

Concentration in earthworm Concentration in food of fish eating predator

Concentration in food of fish eating top-predator (marine)

Concentration in earthworm Concentration in food of fish eating predator

Concentration in food of fish eating top-predator (marine)

Concentration in earthworm

value 0.0146 0.0104 --

unit mg/kg wwt mg/L --

Measured local exposure concentrations value unit -----

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-0.024

-mg/kg

---

---

0.0146

mg/kg wwt mg/L --

--

--

---

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-7.01E-03

-mg/kg

---

---

0.0146

mg/kg wwt mg/L --

--

--

---

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-0.0177

-mg/kg

---

---

-1.36E-03

0.0104 --

-1.36E-03

0.0104 --

-1.36E-03

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil

For Use 2 Industrial use all concentrations in food of fish eating top predators were 0.0146 mg/kg wwt in freshwater and 1.36E-03 mg/kg wwt in marine environments, respectively. Concentrations in earthworms were 0.024 mg/kg for ERC 6a, 7.01E-03 mg/kg for ERC 6b and 0.0177 mg/kg for ERC 6d.

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The following table shows PEC-values for secondary poisoning. Table 108

Predicted Exposure Concentration in food (PECoral) for secondary poisoning (Use 2 Industrial use)

ERC 6a 6a 6a 6b 6b 6b 6d 6d 6d

Local concentration PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt) PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt) PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt)

Justification

0.0146

PEC oral (local + regional) 0.025

1.36E-03

2.33E-03

EUSES (v2.1) calculations

0.024

2.45E-02

EUSES (v2.1) calculations

0.0146

0.025

EUSES (v2.1) calculations

1.36E-03

2.33E-03

EUSES (v2.1) calculations

7.01E-03

7.54E-03

EUSES (v2.1) calculations

0.0146

0.025

EUSES (v2.1) calculations

1.36E-03

2.33E-03

EUSES (v2.1) calculations

0.0177

1.82E-02

EUSES (v2.1) calculations

EUSES (v2.1) calculations

For Use 2 Industrial use all PECoral-values for top predators were 0.025 mg/kg wwt in freshwater and 2.33E-03 mg/kg wwt in marine environments. Concentrations in earthworms were 2.45E 02 mg/kg for ERC 6a, 7.54E-03 mg/kg for ERC 6b and 1.82E-02 mg/kg for ERC 6d. PEC-values were used for risk characterisation.

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9.4

Use 3 Professional use

9.4.1

Exposure scenario

SCC Project No. 375-007 12 November 2010

1. Title Free short title

Professional Use

Systematic title based on use descriptor

SU 22 Professional uses End uses of substances in preparations for professional use ECETOC TRA/EUSES

Processes, tasks activities covered Assessment Method

2. Operational conditions and risk management measures PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9 Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Filling lines specifically designed to both capture vapour and aerosol emissions and minimise spillage. PROC 10 Roller application Low energy spreading of e.g. coatings. Including cleaning of surfaces. Substance can be inhaled as vapours, skin contact can occur through droplets, splashes, working with wipes and handling of treated surfaces. PROC 11 Non industrial spraying Air dispersive techniques. PROC 13 Treatment of articles by dipping and pouring Immersion operations. Treatment of articles by dipping, pouring, immersing, soaking, washing out or washing in substances; including cold formation or resin type matrix. Includes handling of treated objects (e.g. after dying, plating,). PROC 14 Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC 15 Use as laboratory reagent PROC 19 Hand-mixing with intimate contact and only PPE available PROC 23 Open processing and transfer operations with minerals/metals at elevated temperature ERC 8b Wide dispersive indoor use of reactive substances in open systems ERC 8e Wide dispersive outdoor use of reactive substances in open systems Number of sites: wide dispersive use 2.1 Control of workers exposure Product characteristics Physical state: solid Concentration: up to 100 % Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight packaging: 25 and 50 kg polyethylene bags, 1 t big bag (polypropylene coated textile) Physical state: liquid Concentration: max. 25 % (tier I concentrations up to 100 %) Amounts used

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NA Frequency and duration of use/exposure Duration [for one worker]: 6-8 hours/day Frequency [for one worker]: 365 days/year Human factors not influenced by risk management Respiration volume under conditions of use: 10 m3/8h-day (light activity) Area of potential skin contact under conditions of use: two hands and face (480 cm2) Body weight: 70 kg (worker) Other given operational conditions affecting workers exposure Wearing of protective clothing/personal protective equipment is mandatory. Technical conditions and measures at process level (source) to prevent release General ventilation. Technical conditions and measures to control dispersion from source towards the worker Keep container tightly closed in a cool and dry place. Storage away from foodstuffs, reducing agents, heavy-metal compounds, acids and alkalis, protected from humidity and water. Protect from sources of heat. Store not together with inflammable substances. Organisational measures to prevent /limit releases, dispersion and exposure Information on use and application provided. Personnel are trained. Conditions and measures related to personal protection, hygiene and health evaluation General protective and hygienic measures: Keep away from foodstuffs, beverages and food. Take off immediately all contaminated clothing. Clean skin thoroughly immediately after handling the product. Ensure that washing facilities are available in the work place. Avoid contact with the eyes and skin. Do not breathe dust. • Breathing equipment (according to EN 143): use breathing filter apparatus (half mask P2 APF 10, or P3 APF 20). • Protection of hands (according to EN 374),: material: rubber or PVC or other plastic material gloves, glove thickness: 0.5 mm, break through time: >= 8 h • Eye protection (according to EN 166): tightly sealed safety goggles, face protection • Skin and body protection: Light weight protective clothing, rubber or neoprene footwear 2.2 Control of environmental exposure Product characteristics Physical state: solid Concentration: up to 100 % Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight packaging: 25 and 50 kg polyethylene bags, 1 t big bag (polypropylene coated textile) Physical state: liquid Concentration: max. 25 % (tier I concentrations up to 100 %) Amounts used Fraction of the main local source: 0.002 Annual amount: 40000 t/year Emission days per site: max. 365 days/year Frequency and duration of use Page 165 of 323 67/119

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Continuous release; 365 days/year Environment factors not influenced by risk management Dilution factor: rivers = 10 (default), coastal zones = 100 (default) Other given operational conditions affecting environmental exposure There is practically no disposal or run-off into soil, wastewater, drains and sewers. The substance undergoes a complete reaction. No unreacted persulfate remains in the final product. Technical conditions and measures at process level (source) to prevent release General ventilation. Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Substance emissions can be practically excluded. Organizational measures to prevent/limit release from site Information on use and application provided. Personnel are trained. Conditions and measures related to municipal sewage treatment plant 2000 m3/day (default) Conditions and measures related to external treatment of waste for disposal Normally there is no waste, as no unreacted persulfate remains in the final product. Conditions and measures related to external recovery of waste None 3. Exposure estimation and reference to its source Workers: see 9.4.2.1 and 9.4.2.3 Environment: see 9.4.2.4 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES See MSDS. 9.4.2

Exposure estimation

The following table summarises process categories (PROCs) assigned to occupational worker exposure for Use 3 professional use. Exposure concentrations were calculated using ECETOC TRA (2009). Table 109

ECETOC TRA occupational exposure scenarios (Use 3 Professional use)

Process Category (PROC) PROC 8a

PROC 8b

PROC 9 PROC 10 PROC 11 PROC 13 PROC 14

Description Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Roller application or brushing Non industrial spraying Treatment of articles by dipping and pouring Production of preparations or articles by tabletting, Page 166 of 323 68/119

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Process Category (PROC)

Description compression, extrusion, pelletisation Use as laboratory reagent Hand-mixing with intimate contact and only PPE available Open processing and transfer operations with minerals/metals at elevated temperature

PROC 15 PROC 19 PROC 23

Details on exposure calculations are shown in Annex I. 9.4.2.1 Workers exposure 9.4.2.1.1

Acute/Short term exposure

No acute/short term exposure was considered. All exposure periods considered were long term, covering a repeated 8 h/day work shifts. 9.4.2.1.2

Long term exposure

The following table shows worst-case long term exposure concentrations to workers (> 4 h/day exposure, full shift), listing exposures for relevant PROCs. Exposure concentrations were calculated using ECETOC TRA (2009, see Annex I). Solid and liquid preparations (preparation concentrations of up to 100 %, TRA > 25 %) were included, as well as indoor and outdoor use (if applicable). Risk minimisation methods include respiratory protection (half mask P2 APF 10, 90 % protection) and gloves (90 % protection). Table 110

Long term exposure concentrations to workers (Use 3 Professional use)

Routes of exposure

Dermal exposure PROC 8a (solid) PROC 8a (liquid) PROC 8a (outdoors, solid) PROC 8a (outdoors, liquid) PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 15 (solid) PROC 15 (liquid) PROC 23 (solid) PROC 23 (outdoors, solid) Inhalation exposure PROC 8a (solid) PROC 8a (liquid) PROC 8a (outdoors, solid)

Estimated Exposure Concentrations value

unit

Measured exposure concentrations value unit

Explanation / source of measured data

1.3714 1.3714 0.9600 0.9600 0.6857 0.6857 0.6857 0.6857 0.4800 0.4800 1.3714 1.3714 0.9600 0.9600 0.3428 0.3428 0.0342 0.0342 0.1414 0.0990

mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

---------------------

---------------------

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

0.5000 0.1022 0.3500

mg/m³ mg/m³ mg/m³

----

----

ECETOC TRA ECETOC TRA ECETOC TRA

ECETOC TRA ECETOC TRA

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Routes of exposure

PROC 8a (outdoors, liquid) PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 15 (solid) PROC 15 (liquid) PROC 23 (solid) PROC 23 (outdoors, solid) Combined exposure PROC 8a (solid) PROC 8a (liquid) PROC 8a (outdoors, solid) PROC 8a (outdoors, liquid) PROC 8b (solid) PROC 8b (liquid) PROC 9 (solid) PROC 9 (liquid) PROC 9 (outdoors, solid) PROC 9 (outdoors, liquid) PROC 13 (solid) PROC 13 (liquid) PROC 13 (outdoors, solid) PROC 13 (outdoors, liquid) PROC 14 (solid) PROC 14 (liquid) PROC 15 (solid) PROC 15 (liquid)) PROC 23 (solid) PROC 23 (outdoors, solid)

SCC Project No. 375-007 12 November 2010

Estimated Exposure Concentrations value 0.0716 0.5000 0.1022 0.5000 0.1023 0.3500 0.0716 0.5000 0.1022 0.3500 0.0716 0.5000 0.1022 0.0500 0.1022 0.5000 0.3500

unit mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³ mg/m³

1.4428 1.3860 1.0100 0.9702 0.7571 0.7003 0.0376 0.7003 0.5300 0.4902 1.4428 1.3860 1.0100 0.9702 0.4142 0.3574 0.0414 0.0488 0.0242 0.1490

mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

Measured exposure concentrations value unit ---------------------------

Explanation / source of measured data

----

ECETOC TRA ECETOC TRA ECETOC TRA

---------------------

-------------------------

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA ECETOC TRA

Exposure concentrations were estimated for each of the relevant PROCs, with personal protective equipment applied as outlined above and in section 9.2.12. PROCs 8a and 13 when the substance is used in its solid form revealed highest concentrations for overall exposure with 1.4428 mg/kg bw/day. Summary of the long term exposure values. The following table summarizes worst-case long term exposure concentrations to workers for each exposure route calculated by ECETOC TRA. ECETOC TRA calculations for inhalation exposure assumed wearing a respiratory protective mask (half mask P2 APF 10, 90 % protection or P3 APF 20, 95 % protection). ECETOC TRA calculations for dermal exposures assumed wearing gloves, Page 168 of 323 70/119

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with a reduction of exposures by 90 % (TNsG, 2007). The worst-case dermal systemic exposure concentration (mg/kg bw/day) was converted to a local exposure concentration (mg/cm2/day), assuming exposure of two hands and face (480 cm²) for a 70 kg worker (ECHA CSA R14, 2008): 1.3714 mg/kg bw/day * 70 kg / 480 cm2 = 0.1999 mg/cm2/day. Table 111

Summary of ECETOC TRA long term exposure concentration to workers (Use 3 Professional use)

Routes of exposure Dermal local exposure (in mg/cm²day) Dermal systemic exposure (in mg/kg bw/day) Inhalation exposure (in mg/m³/8h work day) Combined systemic exposure (in mg/kg bw/day)

Concentrations 0.1999 1.3714 0.5000 1.4428

Justification See calculation ECETOC TRA (Annex I) ECETOC TRA (Annex I) ECETOC TRA (Annex I)

For Use 3 Professional use highest tier I exposure concentrations to workers were 1.3714 mg/kg bw/day for systemic dermal exposure, corresponding to 0.19999 mg/cm² dermal local exposure and 0.5000 mg/m³/day for inhalation exposure. Highest combined exposure was 1.4428 mg/kg bw/day. All estimated exposure concentrations were considered worst-case. Exposure for professional roller/brushing application (PROC 10) was assessed in a tier II analysis. For tier I see ECETOC calculations in Annex I. Tier II assessments were calculated using ConsExpo (v4.1, RIVM, 2005). The scenario was selected from the “painting products” product database including product category “Brush and roller painting– water borne paint”. Default parameters were taken from RIVM ConsExpo Paint Products Fact sheet (2007) and adjusted for professional applications. All calculations reflect a worst-case tier II approach. Parameters adjusted for professional use included setting the exposure frequency to 300 days a year, increasing the body weight to 70 kg (worker), increasing inhalation rate to light exercise and extending spray and exposure duration to full shift, i.e. 360 min rolling/brushing and 480 min. exposure (following ECB Data Base on Human Exposure for PT 7 and PT10, 2007). The weight fraction of the compound was set to 0.25. Update fractions were set at 1.0 for inhalation and 0.1 for dermal uptake, reflecting the worst-case scenario with appropriate risk minimisation methods applied. Workers dermal exposure area was set to 960 cm² for hands, face and upper surface (ECETOC TRA Targeted Risk Assessment, Technical Report no. 93). Further, workers were assumed to wear gloves, leading to dermal uptake fractions of 0.1. Defaults and adjusted parameters for professional roller/brushing applications are shown in the following: General Exposure Data exposure frequency body weight

300 70

1/year kilogram

Inhalation model: Exposure to vapour : evaporation weight fraction compound exposure duration room volume ventilation rate applied amount release area application duration mol weight matrix mass transfer rate

0.25 480 20 0.6 1.25E3 1E5 360 45 0.203

fraction minute m3 1/hr gram cm2 minute g/mol m/min

Uptake model: Fraction uptake fraction inhalation rate

1 36.4

fraction m3/day Page 169 of 323 71/119

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Dermal model: Direct dermal contact with product : constant rate weight fraction compound exposed area contact rate release duration

0.25 960 30 360

fraction cm2 mg/min minute

Uptake model: fraction uptake fraction

0.1

fraction

Output Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

8.4E-21 mg/m3 2.8E-21 mg/m3 2.3E-21 mg/m3/day 1.46E-21 mg/kg 1.2E-21 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

2.81 38.6 3.86 3.17

mg/cm2 mg/kg mg/kg mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

38.6 3.86 3.17

mg/kg mg/kg mg/kg/day

For professional roller/brushing application (PROC 10) calculated by ConsExpo, the relevant exposure concentrations for dermal exposure, inhalation exposure and combined systemic exposure were 3.17 mg/kg/day, 2.3E-21 mg/m³/day and 3.17 mg/kg/day, respectively. Exposure for professional spraying application (PROC 11) was assessed in a tier II analysis. For tier I see ECETOC calculations in Annex I. Tier II assessments were calculated using ConsExpo (v4.1, RIVM, 2005). The scenario selected was the “painting products” product database product category “spray painting – pneumatic spraying”. Default parameters were taken from RIVM ConsExpo Paint Products Fact sheet (2007) and adjusted for professional applications. All calculations reflect a worst-case tier II approach. Parameters adjusted for professional use included setting the exposure frequency to 300 days a year, increasing the body weight to 70 kg (worker), increasing the inhalation rate to light exercise and extending exposure duration to full shift, i.e. 360 min application and 480 min. exposure (following ECB Data Base on Human Exposure for PT 7 and PT10, 2007). The weight fraction of the compound was set to 0.25, reflecting the worst-case scenario. Workers dermal exposure area was set to 1500 cm² for forearms and hands (ECETOC TRA Targeted Risk Assessment, Technical Report no. 93). Further, workers were assumed to wear gloves, leading to dermal uptake fractions of 0.1. Defaults and adjusted parameters for professional roller/brushing applications are shown in the following: General Exposure Data exposure frequency body weight

300 70

1/year kilogram

Inhalation model: Exposure to spray Page 170 of 323 72/119

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weight fraction compound exposure duration room volume ventilation rate mass generation rate spray duration airborn fraction weight fraction non-volatile density non-volatile room height inhalation cut-off diameter non-respirable uptake fraction Spraying away from exposed person

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0.25 480 34 1.5 0.5 360 0.2 0.5 1.5 2.25 15 0

fraction minute m3 1/hr g/sec minute fraction fraction g/cm3 meter micrometer fraction

Uptake model: Fraction uptake fraction inhalation rate

1 36.4

fraction m3/day

Dermal model: Direct dermal contact with product : constant rate weight fraction compound exposed area contact rate release duration

0.25 1.5E3 110 798

fraction cm2 mg/min second

Uptake model: fraction uptake fraction

0.1

fraction

Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.54 0.845 0.694 0.439 0.361

mg/m3 mg/m3 mg/m3/day mg/kg mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.244 5.23 0.523 0.429

mg/cm2 mg/kg mg/kg mg/kg/day

Oral non-respirable: point estimates oral external dose : oral acute (internal) dose : oral chronic (internal) dose :

0 mg/kg 0 mg/kg 0 mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

8.63 0.962 0.79

Output

mg/kg mg/kg mg/kg/day

For industrial spraying (PROC 11) calculated by ConsExpo the relevant exposure concentrations for dermal exposure, inhalation exposure and combined systemic exposure were 0.429 mg/kg/day, 0.694 mg/m³/day and 0.79 mg/kg/day, respectively. Page 171 of 323 73/119

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Exposure for professional hand mixing with intimate contact and only PPE available (PROC 19) was assessed in a tier II analysis. For tier I see ECETOC calculations in Annex I. Tier II assessments were calculated using ConsExpo (v4.1, RIVM, 2005).The scenario was selected from the “painting products” product database product category “brush and roller painting – two component. Default parameters were taken from RIVM ConsExpo Paint Products Fact sheet (2007) and adjusted for professional applications. All calculations reflect a worst-case tier II approach. Parameters adjusted for professional use included setting the exposure frequency to 300 days a year, increasing the body weight to 70 kg (worker), increasing inhalation rate to light exercise and exposure duration to full shift, i.e. 360 min application and 480 min. exposure (following ECB Data Base on Human Exposure for PT 7 and PT10, 2007). The weight fraction of the compound was set to 0.25, reflecting the worst-case scenario. Workers dermal exposure area was set to 480 cm² for hands (ECETOC TRA Targeted Risk Assessment, Technical Report no. 93). Further, workers were assumed to wear gloves, leading to dermal uptake fractions of 0.1. Defaults and adjusted parameters for are shown in the following: General Exposure Data exposure frequency body weight

300 70

1/year kilogram

Inhalation model: Exposure to vapour : evaporation weight fraction compound exposure duration room volume ventilation rate applied amount release area application duration mol weight matrix mass transfer rate

0.25 480 1 0.6 200 95 480 3E3 2.27E3

fraction minute m3 1/hr gram cm2 minute g/mol m/min

Uptake model: Fraction uptake fraction inhalation rate

1 36.4

fraction m3/day

Dermal model: Direct dermal contact with product : instant application weight fraction compound 0.25 exposed area 480 applied amount 5

fraction cm2 gram

Uptake model: fraction uptake fraction

fraction

0.1

Output Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose : Dermal : point estimates dermal load : dermal external dose :

1.71E-19 mg/m3 5.7E-20 mg/m3 4.68E-20 mg/m3/day 2.96E-20 mg/kg 2.43E-20 mg/kg/day

2.6 17.9

mg/cm2 mg/kg Page 172 of 323 74/119

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dermal acute (internal) dose : dermal chronic (internal) dose :

1.79 1.47

mg/kg mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

17.9 1.79 1.47

mg/kg mg/kg mg/kg/day

For PROC 19 calculated by ConsExpo, the relevant exposure concentrations for dermal exposure, inhalation exposure and combined systemic exposure were 1.47 mg/kg/day, 4.68E-20mg/m³/day and 1.47 mg/kg/day, respectively. The following table summarizes worst-case long term exposure concentrations to workers for each exposure routes, as calculated for each of the relevant applications using ECETOC TRA and ConsExpo: Table 112

Summary of overall long term exposure concentration to workers (Use 3 Professional use)

Routes of exposure Dermal local exposure (in mg/cm²day) Dermal systemic exposure (in mg/kg bw/day) Inhalation exposure (in mg/m³/8h work day) Combined systemic exposure (in mg/kg bw/day)

Concentrations 0.2311 3.1700 0.6940 3.1700

Justification See calculation ConsExpo (v4.1) ConsExpo (v4.1) ConsExpo (v4.1)

The worst-case dermal systemic exposure concentration (mg/kg bw/day) was converted to a local exposure concentration (mg/cm2/day), assuming exposure of two hands, face and upper surface (960 cm²) for a 70 kg worker (ECHA CSA R14, 2008): 3.1700 mg/kg bw/day * 70 kg / 960 cm2 = 0.2311 mg/cm2/day. Use 3 Professional use tier I and II highest exposure values are for dermal local exposure 0.2311 mg/cm²/day, for dermal systemic exposure 3.1700, for inhalation exposure 0.6940 mg/m³/day and for combined systemic exposure 3.1700 mg/kg bw/day. 9.4.2.2 Consumer use Not relevant for this substance life cycle step. 9.4.2.3 Indirect exposure of humans via the environment (oral) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (v2.1, see Annex II). Specific ERC release values were installed in the EUSES model. The following table shows the specific ERC used. Table 113

ECETOC TRA scenario (Use 3 Professional use)

Environmental Release Category (ERC) ERC 8b ERC 8e

Description Wide dispersive indoor use of reactive substances in open systems Wide dispersive outdoor use of reactive substances in open systems

The following table shows the indirect exposure of humans via the environment.

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Table 114

Concentration for oral exposure of humans via the environment

ERC

8b 8b 8b 8b 8b 8b 8b 8b 8e 8e 8e 8e 8e 8e 8e 8e

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Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose

Estimated exposure concentrations value unit 7.48E-05 mg/kg/day 9.21E-04 mg/L/day 6.54E-09 mg/kg/day 3.95E-05 mg/kg/day 2.39E-05 mg/kg/day 1.22E-07 mg/kg/day 7.45E-11 mg/m3 1.06E-03 mg/kg/day 7.48E-05 mg/kg/day 9.21E-04 mg/L/day 6.54E-09 mg/kg/day 3.95E-05 mg/kg/day 2.39E-05 mg/kg/day 1.22E-07 mg/kg/day 7.45E-11 mg/m3 1.06E-03 mg/kg/day

Measured exposure concentrations value unit ---------------------------------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 3 Professional use ERC 8b and ERC 8c calculated total daily concentrations for indirect exposure of humans via the environment were 1.06E-03 mg/kg/day, respectively. The following table shows total daily doses for oral exposure of humans via the environment. Table 115

Total daily dose for oral exposure of humans via the environment

Total daily dose for oral exposure via the environment (mg/kg bw/d) ERC Exposed via local Exposed via local and regional concentration concentration 8b 1.06E-03 1.42E-03 8e 1.06E-03 1.42E-03

Justification

EUSES (v2.1) EUSES (v2.1)

For Use 3 Professional use ERC 8b and ERC 8c the total daily doses for oral exposure of humans via the environment were 1.06E-03 mg/kg/day, respectively. The regional total daily concentration was 1.42E 04 mg/kg/day (see section 9.6). 9.4.2.4 Environmental exposure (Use 3 Professional use) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (v2.1, see Annex II). Specific ERC release values were installed in the EUSES model. The following table shows the specific ERC used. Table 116

ECETOC TRA scenario (Use 3 Professional use)

Environmental Release Category (ERC) ERC 8b ERC 8e

Description Wide dispersive indoor use of reactive substances in open systems Wide dispersive outdoor use of reactive substances in open systems

The section below shows tier II exposure assessment results.

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9.4.2.4.1 Environmental releases The following table shows estimated releases to relevant compartments of the environment. No measured data was available. Data was calculated by EUSES (v2.1; Annex II). Table 117

Releases to the environment (local)

ERC

Compartments

8b 8b 8b 8b 8b 8e 8e 8e 8e 8e

Air Waste water Surface water Industrial soil Agricultural soil Air Waste water Surface water Industrial soil Agricultural soil

Predicted releases 0 kg/day 0.438 kg/day ---0 kg/day 0.438 kg/day ----

Measured release (kg/d) -----------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 3 Professional use ERC 8b and ERC 8e estimated maximal released amount into waste water was 0.438 kg/day, respectively. Releases to air were 0 kg/day. The following table shows estimated point source releases and estimated total releases for regional exposures. All relevant compartments were taken into account for exposure estimations. Table 118

Summary of the releases to the environment

ERC

Compartments

8b 8b 8b 8b 8e 8e 8e 8e

Air Wastewater Surface water Industrial soil Air Wastewater Surface water Industrial soil

Release from point source (local exposure estimation) 0 kg/day 0.438 kg/day --0 kg/day 0.438 kg/day ---

Total release for regional exposure estimation

Justification

11 kg/day 219 kg/day 0 kg/day 0 kg/day 11 kg/day 219 kg/day 0 kg/day 0 kg/day

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 3 Professional use local release values to waste water for ERC 8b and 8e were 0.438 kg/day, respectively. Total regional releases were 11 kg/day to air and 219 kg/day to wastewater, respectively. Release values were used for calculation of environmental compartment predicted environmental concentrations.

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9.4.2.4.2

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Exposure concentration in sewage treatment plants (STP)

The following table shows estimated concentrations in waste water. Only estimated data calculated by EUSES 2.1 (Annex II) was available. No monitoring data was available. Table 119

Concentrations in sewage (Use 3 Professional use)

ERC

Compartments

Measured exposure concentrations

Explanation / source of measured data

Sewage (STP effluent)

Estimated exposure concentrations value unit 0.219 mg/L

8b

value --

unit --

EUSES (v2.1)

8b

Sewage sludge

0.219

mg/kg

--

--

EUSES (v2.1)

8e

Sewage (STP effluent)

0.219

mg/L

--

--

EUSES (v2.1)

8e

Sewage sludge

0.219

mg/kg

--

--

EUSES (v2.1)

8e

Sewage sludge

0.219 mg/kg --

--

EUSES (v2.1)

For Use 3 Professional use ERC 8b and ERC 8e concentrations in sewage effluent and sewage sludge were 0.219 mg/kg and 0.219 mg/L, respectively. The following table summarises exposure concentrations in sewage treatment plants. Table 120 ERC 8b 8b 8b 8e 8e 8e

Predicted Exposure Concentrations (PEC) in sewage (Use 3 Professional use)

Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw) Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw) Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw)

Value 0.219 0.219 0.219 0.219 0.219 0.219

Justification EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 3 Professional use ERC 8b and 8e predicted effect concentrations in sewage and concentrations in sewage sludge were 0.219 mg/L and 0.219 mg/kg, respectively. 9.4.2.4.3

Exposure concentration in aquatic pelagic compartment

The exposure in aquatic pelagic compartment was calculated by EUSES 2.1 (Annex II). The following table shows estimated concentrations for freshwater and marine compartments. No monitoring data was available.

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Table 121

Local concentrations in water (Use 3 Professional use)

ERC

Compartments

8b

Freshwater

8b

8b 8e

8e

8e

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Marine water

Intermittent releases to water Freshwater

Marine water

Intermittent releases to water

Estimated exposure concentrations value 0.0219

unit mg/L

Measured local exposure concentrations value unit ---

0.0104 0.0322

mg/L mg/L

---

---

-2.19E-03

-mg/L

---

---

9.66E-04 3.16E-03

mg/L mg/L

---

---

---

---

---

---

0.0219

mg/L

--

--

0.0104 0.0322

mg/L mg/L

---

---

-2.19E-03

-mg/L

---

---

9.66E-04 3.16E-03

mg/L mg/L

---

---

---

---

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available No intermittent releases to water Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available No intermittent releases to water

For Use 3 Professional use ERC 8b and ERC 8e local estimated predicted exposure concentrations in freshwater and marine water were 0.0219 mg/L and 2.19E-03 mg/L, respectively. Regional estimated predicted exposure concentrations in freshwater and marine water were 0.0104 mg/L and 9.66E 04 mg/L, respectively. The following table shows summarized PEC-values for aquatic compartments.

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Table 122

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Predicted Exposure Concentrations (PEC) in aquatic compartment (Use 3 Professional use)

ERC

Compartments Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

Local concentration 0.0219 2.19E-03 --

PEC aquatic (local+regional) 0.0322 3.16E-03 --

8b 8b 8b 8e 8e 8e

Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

0.0219 2.19E-03 --

0.0322 3.16E-03 --

Justification EUSES (v2.1) EUSES (v2.1) No intermittent releases to water EUSES (v2.1) EUSES (v2.1) No intermittent releases to water

For Use 3 Professional use all PEC-values in freshwater and marine water were 0.0322 mg/L and 3.16E-03 mg/L, respectively. PEC-values were used for risk characterisation. 9.4.2.4.4

Exposure concentration in sediments

The following table shows estimated exposure concentrations for sediments calculated by EUSES 2.1 (Annex II). No monitoring data was available. Table 123

Local concentrations in sediment (Use 3 Professional use)

ERC

Compartments

8b

Freshwater sediments

8b

8e

8e

Marine water sediments

Freshwater sediments

Marine water sediments

Estimated exposure concentrations value --

unit --

Measured local exposure concentrations value unit ---

7.09E-03 0.0274

mg/kg wwt mg/kg wwt

---

---

---

---

---

---

6.69E-04 2.69E-03

mg/kg wwt mg/kg wwt

---

---

---

---

---

---

7.09E-03 0.0274

mg/kg wwt mg/kg wwt

---

---

---

----

---

---

6.69E-04 2.69E-03

mg/kg wwt mg/kg wwt

---

---

--

--

--

--

Explanation / source of measured data

No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available.

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For Use 3 Professional use ERC 8b and ERC 8e PEC-values were 0.0274 mg/kg wwt for freshwater sediments and 2.69E-03 mg/kg wwt for marine water sediments, respectively. The following table shows PEC-values for freshwater and marine sediments. Summarized exposure concentrations in aquatic sediments were taken into account for risk characterisation. Table 124

Predicted Exposure Concentrations (PEC) in sediments (Use 3 Professional use)

ERC

Compartments

8b

Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt) Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt)

8b 8e 8e

Local concentration --

PEC sediment (local+regional) 0.0274

Justification

--

2.69E-03

EUSES (v2.1)

--

0.0274

EUSES (v2.1)

--

2.69E-03

EUSES (v2.1)

EUSES (v2.1)

For Use 3 Professional use ERC 8b and ERC 8e calculated PEC-values in sediments were 0.0274 mg/kg wwt for freshwater sediments and 2.69E-03 mg/kg wwt for marine water sediments, respectively. PEC-values were used for risk characterisation. 9.4.2.4.5

Exposure concentrations in soil and groundwater

The following table shows estimated local concentrations in soil and groundwater calculated by EUSES (Annex 2.1). No monitoring data was available. Table 125

Local concentrations in soil (Use 3 Professional use)

ERC

Compartments

8b

Agricultural soil averaged

Estimated exposure concentrations

Measured local exposure concentrations value unit ---

value 2.54E-04

unit mg/kg wwt

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

1.02E-04

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

9.63E-04

8.11E-04

8b

Grassland averaged

2.83E-05

mg/kg wwt

--

--

8b

Groundwater

--

--

--

--

8e

Agricultural soil averaged

2.54E-04

mg/kg wwt

--

--

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation for average 30 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES. Estimated local exposure concentration based on EUSES Page 179 of 323 81/119

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Compartments

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Estimated exposure concentrations

Measured local exposure concentrations value unit

value

unit

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

1.02E-04

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

9.63E-04

8.11E-04

8e

Grassland averaged

2.83E-05

mg/kg wwt

--

--

8e

Groundwater

--

--

--

--

Explanation / source of measured data

calculation for average 30 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES.

For Use 3 Professional use ERC 8b and 8e estimated concentrations were 2.54E-04 mg/kg wwt for agricultural soil averaged over 30 days, 1.02E-04 mg/kg wwt for agricultural soil averaged over 180 days and 2.83E-05 mg/kg wwt for grassland, respectively. The following table shows PEC-values for soil and groundwater. Table 126

Predicted Exposure Concentrations (PEC) in soil and groundwater(Use 3 Professional use)

ERC 8b

8b 8b 8e

8e 8e

Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L) Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L)

Local concentration 2.54E-04 1.02E-04

PEC soil/groundwater (local + regional) 9.63E-04 8.11E-04

Justification

2.83E-05 -2.54E-04 1.02E-04

7.38E-04 4.68E-03 9.63E-04 8.11E-04

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

2.83E-05 --

7.83E-04 4.68E-03

EUSES (v2.1) EUSES (v2.1)

EUSES (v2.1) EUSES (v2.1)

For Use 3 Professional use ERC 8b and 8e calculated PEC-values were 9.63E-04 mg/kg wwt for agricultural soil averaged over 30 days, 8.11E-04 mg/kg wwt for agricultural soil averaged over 180 days, 7.38E-04 mg/kg wwt for grassland and 4.68E-03 mg/L for groundwater, respectively. 9.4.2.4.6

Atmospheric compartment

The following table shows estimated local concentrations in air calculated by EUSES (v2.1, Annex II).

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Table 127

Local concentrations in air (Use 3 Professional use)

ERC

8b

Estimated exposure concentrations

During emission

8b

Annual average

8b

Annual total deposition During emission

8e

8e

Annual average

8e

SCC Project No. 375-007 12 November 2010

Annual total deposition

value 2.24E-10

unit mg/m3

Measured local exposure concentrations value unit ---

--

--

--

--

-2.24E-10

-mg/m3

---

---

3.67E-11 2.61E-10

mg/m3 mg/m3

---

---

-8.02E-09

---

---

2.24E-10

-mg/m2/ day mg/m3

--

--

--

--

--

--

-2.24E-10

-mg/m3

---

---

3.67E-11 2.61E-10

mg/m3 mg/m3

---

---

-8.02E-09

-mg/m2/ day

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation.

For Use 3 Professional use ERC 8b and 8e estimated total emission to the atmospheric compartment was 2.24E-10 mg/m3, the annual average was 2.24E-10 mg/m3 with an annual deposition of 8.02E-09 mg/m2/day, respectively. The following table shows PEC-values for the atmospheric compartment. Table 128

Predicted Exposure Concentration (PEC) in air (Use 3 Professional use)

ERC

Local concentration 2.24E-10 2.24E-10

PEC air (local + regional) -2.61E-10

Justification

8b 8b

During emission (mg/m3) Annual average (mg/m3)

8b

Annual deposition (mg/m2/day) During emission (mg/m3) Annual average (mg/m3)

8.02E-09

--

EUSES (v2.1)

2.24E-10 2.24E-10

-2.61E-10

EUSES (v2.1) EUSES (v2.1)

Annual deposition (mg/m2/day)

8.02E-09

--

EUSES (v2.1)

8e 8e 8e

EUSES (v2.1) EUSES (v2.1)

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For Use 3 Professional use ERC 8b and 8e calculated PEC-values for annual average were 2.61E 10 mg/m3, respectively. PEC-values were used for risk characterisation. 9.4.2.4.7

Exposure concentration relevant for the food chain (Secondary poisoning)

The following table shows exposure concentrations relevant for the food chain (secondary poisoning) calculated by EUSES (v2.1, Annex II). No monitoring data was available. Table 129

Local concentration relevant for secondary poisoning (Use 3 Professional use)

ERC

8b

8b

8b 8e

8e

8e

Predicted exposure concentrations

Concentration in food of fish eating predator

Concentration in food of fish eating top-predator (marine)

Concentration in earthworm Concentration in food of fish eating predator

Concentration in food of fish eating top-predator (marine)

Concentration in earthworm

value 0.0301 0.0104 --

unit mg/kg wwt mg/L --

Measured local exposure concentrations value unit -----

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-2.98E-03

-mg/kg

---

---

0.0301

mg/kg wwt mg/L --

--

--

---

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-2.98E-03

-mg/kg

---

---

-1.67E-03

0.0104 --

-1.67E-03

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil

For Use 3 Professional use ERC 8b and 8e concentrations in food of fish eating predators were 0.0301 mg/kg wwt, concentrations in food of fish eating top-predators (marine) were 1.67E 03 mg/kg wwt, respectively. Concentrations in earthworms were 2.98E-03 mg/kg for ERC 8b and 8e. The following table shows PEC-values for secondary poisoning.

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Table 130

Predicted Exposure Concentration in food (PECoral) for secondary poisoning (Use 3 Professional use)

ERC 8b 8b 8b 8e 8e 8e

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Local concentration PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt) PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt)

Justification

0.0301

PEC oral (local + regional) 4.05E-02

1.67E-03

2.64E-03

EUSES (v2.1) calculations

2.98E-03

3.51E-02

EUSES (v2.1) calculations

0.0301

4.05E-02

EUSES (v2.1) calculations

1.67E-03

2.64E-03

EUSES (v2.1) calculations

2.98E-03

3.51E-03

EUSES (v2.1) calculations

EUSES (v2.1) calculations

For Use 3 Professional use ERC 8b and 8e PECoral-values for top predators were 4.05E-02 mg/kg wwt in freshwater and 2.64E-03 mg/kg wwt in marine environments. Concentrations in earthworms were 3.51E-03 mg/kg for ERC 8b and 8e. PEC-values were used for risk characterisation.

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9.5

Use 4 Consumer use (General Public)

9.5.1

Exposure scenario

1. Title Free short title

Consumer Use

Systematic title based on use descriptor

SU 21 Consumer uses End uses of substances in preparations for consumer use ConsExpo (v4.1)

Processes, tasks activities covered Assessment Method

2. Operational conditions and risk management measures PC 14 Metal surface treatment products, including galvanic and electroplating products PC 37 Water treatment chemicals PC 39 Cosmetics, personal care products ERC 8b Wide dispersive indoor use of reactive substances in open systems ERC 8e Wide dispersive outdoor use of reactive substances in open systems 2.1 Control of consumers exposure Product characteristics Physical state: solid Concentration: up to 100 % Powder: dustiness max. 13 % of particles below 10 µm Packaging: moisture-resistant, dust-tight Physical state: liquid Concentration: max. 25 % (tier I concentrations up to 100 %) PC 14 Product amount: 37 g Weight fraction compound: 0.1 Frequency and duration of use exposure: 156 days/ year for 10 minutes PC 37 Product amount: 250 g Weight fraction product: 1.0 (mixing and loading), 0.025 (application), 5E-6 (post application) Frequency and duration of use exposure: mixing and loading – 1.33 minutes, application – 5 minutes post application - indoor pool daily use for 6 hours (adult-professional)/ 1 hour (child) post application - outdoor pool 122 days/ year for 6 hours (adult-professional)/ 1 hour (child) post application - spa daily use for 1 hour (adult-professional and child) PC 39 Product amount: 200 g Weight fraction product: 0.08 Frequency and duration of use exposure: 10 times/ year for 45 minutes Human factors not influenced by risk management Dermal exposure area PC 14 – application: 215 cm2 (one palm: 0.25 area hands) PC 37 – mixing and loading: 480 cm2 (two hands and face) PC 37 – application: 1900 cm² (hands and forearms) Page 184 of 323 86/119

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PC 37 – post application: adult 17500 cm² and child 4800 cm² (whole body) PC 39 – cosmetics, personal care products: 580 cm² (half area head Other given operational conditions affecting consumers exposure Default. Conditions and measures related to information and behavioural advice to consumers Safety advice communicated to consumers, e.g. technical instructions, behavioural advice. Conditions and measures related to personal protection and hygiene None 2.2 Control of environmental exposure Product characteristics Physical state: solid Concentration: up to 100 % Powder: dustiness max. 13 % of particles below 10 µm Physical state: liquid Concentration: max. 25 % (tier I concentrations up to 100 %) Fraction of the main local source: 0.002 Annual amount: 40000 t/year No of days used: 365 Continuous release assumed. Environment factors not influenced by risk management Flow rate of receiving surface water: 18,000 m3/day Other given operational conditions affecting environmental exposure There is practically no disposal or run-off into soil, wastewater, drains and sewers. The substance undergoes a complete reaction. No unreacted persulfate remains in the final product. Other operational conditions, e.g. indoor or outdoor use of products Indoor and outdoor use. Size of municipal sewage system/treatment plant (m3/day): 2000 (default) Conditions and measures related to external treatment of waste for disposal Disposal according to official regulations. Instructions regarding separation of communicated to consumers. Conditions and measures related to external recovery of waste

waste

None 3. Exposure estimation and reference to its source Workers: see 9.5.2.1 and 9.5.2.3 Environment: see 9.5.2.4 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES See MSDS.

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9.5.2

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Exposure estimation

The following table summarises Product Categories (PC) assigned for Use 4 Consumer use and associated exposure scenarios. Table 131

Product category exposure scenario (Use 4 Consumer use)

Product Category (PC) PC 14 PC 37 PC 39

Description Metal surface treatment products Water treatment chemicals Cosmetics, personal care products

9.5.2.1 Workers exposure Not relevant for this life cycle step. 9.5.2.2 Consumer exposure Use 4 Consumer use exposure concentrations were calculated using ConsExpo (RIVM Version 4.1, 2005). For each of the product categories (PC) relevant worst-case scenarios were selected from the ConsExpo default scenarios. The table below shows all PC and corresponding ConsExpo scenarios applied, estimating exposure from products used as metal abrasives (PC 14), disinfectants in swimming pools and spas (PC 37) and for hair bleaching (PC 39). For PC 14, metal surface treatment, two exposure scenarios were evaluated, one each for adult and child. For PC 37, water treatment chemicals, three exposure scenarios were evaluated, including mixing and loading, application and post application, for each use in indoor and outdoor swimming pools as well as spas. Further post application exposure was evaluated for adult and child. For PC 39, cosmetics, personal care products, one exposure scenario was evaluated. For details on ConsExpo scenarios see the table below. Table 132 Product Category (PC) PC 14 (Metal surface treatment) PC 37 (Water treatment chemicals)

PC 39 (Cosmetics, personal care products)

Product categories and ConsExpo exposure scenarios (Use 4 Consumer use) ConsExpo Scenario Product database: cleaning and washing Product category: abrasives Default product: abrasive liquid The exposure scenario was evaluated for adult and child Product database: disinfectants Product category: swimming pool disinfectants Default product: granules Three exposure scenarios were included under each of the indoor swimming pool, outdoor swimming pool and spa scenarios: mixing and loading application post application – examined for adult and child Product database: cosmetic Product category: hair care cosmetics Default product: hair bleach

PC 14 (Metal surface treatment) For PC 14 standard ConsExpo scenario parameters were taken from the RIVM ConsExpo Cleaning Products Fact Sheet (2006) and adjusted for consumer applications, if applicable. All parameters reflect a worst-case tier II approach. Parameters adjusted include setting the body weight to 60 kg (general public) and 10 kg (child) and increasing the inhalation rate to light exercise. The weight fraction of the compound was set at 0.1, reflecting the worst-case scenario. The Page 186 of 323 88/119

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exposure duration per event was set to 10 minutes, with 156 events per year (3 times per week). Defaults and adjusted parameters for the ConsExpo scenarios (adult and child) as well as results are shown below: General Exposure Data exposure frequency body weight kilogram

156 60

1/year (adult), 10

Inhalation model: Exposure to vapour : evaporation weight fraction compound exposure duration room volume ventilation rate applied amount release area application duration mol weight matrix mass transfer rate

0.1 10 2.5 2 37 4E4 10 45 2.27E3

fraction minute m3 1/hr gram cm2 minute g/mol m/min

Uptake model: fraction uptake fraction inhalation rate

1 32.9

fraction m3/day

Dermal model: Direct dermal contact with product : instant application weight fraction compound 0.1 exposed area 215 applied amount 0.37

fraction cm2 gram

Uptake model: fraction uptake fraction

fraction

1

(child)

Following results were obtained for: adult Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

1.21E-19 mg/m3 8.43E-22 mg/m3 3.6E-22 mg/m3/day 4.63E-22 mg/kg 1.98E-22 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.172 0.617 0.617 0.263

mg/cm2 mg/kg mg/kg mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

0.617 0.617 0.263

mg/kg mg/kg mg/kg/day

Following results were obtained for: child Inhalation (point estimates) Page 187 of 323 89/119

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inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

SCC Project No. 375-007 12 November 2010

1.21E-19 mg/m3 8.43E-22 mg/m3 3.6E-22 mg/m3/day 2.78E-21 mg/kg 1.19E-21 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.172 3.7 3.7 1.58

mg/cm2 mg/kg mg/kg mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

3.7 3.7 1.58

mg/kg mg/kg mg/kg/day

PC 37 (Water treatment chemicals) For PC 37 three different scenarios were assessed, including mixing and loading, application and post-application exposure. Exposures were estimated for adult and child in indoor and outdoor settings. Default and adjusted parameters as well as results are shown below. Mixing and loading scenarios The standard parameters for PC 37 “mixing and loading” were taken the RIVM ConsExpo Disinfectant Products Fact Sheet (2006) and adjusted for consumer applications. All calculations reflect a worst-case tier II approach. Substance degradation was not considered during the scenario. Per event 250 g substance was assumed for use in swimming pools (50 g product to 10 m³) of average of 50 m³ size (indoor/ outdoor, RIVM ConsExpo Disinfectant Products Fact Sheet, 2006) and 50 g for spas (10 m³). The weight fraction compound was set to 1.0, assuming pure substance. Exposure frequency was taken from the ConsExpo Disinfectant Products Fact Sheet and set at 122 times a year for outdoor swimming pools and 1 time a week for indoor swimming pools and spas. Per event an exposure duration of 1.33 minute was assumed according to the ConsExpo Disinfectant Products Fact Sheet. Room volume was set to a minimum of 1 m³. Body weight was set to 60 kg (general public), exposed dermal area to 480 cm² (two hands and face) and inhalation set to light exercise. All parameters for the ConsExpo scenarios (adult and child) and results are shown below: Mixing and loading - indoor pools General Exposure Data exposure frequency body weight

1 60

1/week kilogram

Inhalation model: Exposure to vapour : constant rate weight fraction compound exposure duration room volume ventilation rate applied amount release duration

1 1.33 1 0.6 0.25 1.33

fraction minute m3 1/hr kilogram minute

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Uptake model: Fraction uptake fraction inhalation rate

1 32.9

fraction m3/day

Dermal model: Direct dermal contact with product : constant rate weight fraction compound exposed area contact rate release duration

1 480 0.033 79.8

fraction cm2 mg/min second

Uptake model: fraction uptake fraction

1

fraction

Following results were obtained for: mixing and loading – indoors pools Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : mg/m3/day inhalation acute (internal) dose : mg/kg inhalation chronic (internal) dose : mg/kg/day Dermal : point estimates dermal load :

8.83E-26 mg/m3 8.15E-29 mg/m3 1.16E-29 4.47E-29 6.39E-30

2.31E-5

mg/cm2

dermal external dose : 0.000731 mg/kg dermal acute (internal) dose :

0.000732 mg/kg

dermal chronic (internal) dose :

0.000105 mg/kg/day

Integrated (point estimates) total external dose: 0.000731 mg/kg total acute dose (internal): 0.000731 mg/kg total chronic dose (internal):

0.000105 mg/kg/day

Mixing and loading – outdoor pool General Exposure Data exposure frequency body weight

122 60

1/year kilogram

Inhalation model: Exposure to vapour : constant rate weight fraction compound exposure duration room volume ventilation rate applied amount release duration

1 1.33 1 0.6 250 1.33

fraction minute m3 1/hr gram minute

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Uptake model: Fraction uptake fraction inhalation rate

1 32.9

fraction m3/day

Dermal model: Direct dermal contact with product : constant rate weight fraction compound exposed area contact rate release duration

1 480 0.033 79.8

fraction cm2 mg/min second

Uptake model: fraction uptake fraction

1

fraction

Following results were obtained: mixing and loading – outdoor pool Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 mg/m3 2.01E-22 mg/m3 6.7E-23 mg/m3/day 1.1E-22 mg/kg 3.68E-23 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

9.14E-5 0.000731 0.000732 0.000244

mg/cm2 mg/kg mg/kg mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

0.000731 0.000731 0.000244

mg/kg mg/kg mg/kg/day

Mixing and loading – Spa General Exposure Data exposure frequency body weight

1 60

1/week kilogram

Inhalation model: Exposure to vapour : constant rate weight fraction compound exposure duration room volume ventilation rate applied amount release duration

1 1.33 1 0.6 50 1.33

fraction minute m3 1/hr gram minute

Uptake model: Fraction uptake fraction inhalation rate

1 32.9

fraction m3/day

Dermal model: Direct dermal contact with product : constant rate weight fraction compound exposed area contact rate

1 480 0.033

fraction cm2 mg/min Page 190 of 323 92/119

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release duration

79.8

second

Uptake model: fraction uptake fraction Following results were obtained for: mixing and loading – spa

1

fraction

Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 mg/m3 2.01E-22 mg/m3 2.87E-23 mg/m3/day 1.1E-22 mg/kg 1.57E-23 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

9.14E-5 0.000731 0.000732 0.000105

mg/cm2 mg/kg mg/kg mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

0.000731 0.000731 0.000105

mg/kg mg/kg mg/kg/day

Application The standard parameters for PC 37 “application” were taken the RIVM ConsExpo Disinfectant Products Fact Sheet (2006) and adjusted for consumer applications. All calculations reflect a worst-case tier II approach. Substance degradation was not considered during the scenario. Per event 250 g substance was assumed for use in swimming pools (50 g product to 10 m³) of average of 50 m³ size (indoor/ outdoor, RIVM ConsExpo Disinfectant Products Fact Sheet, 2006) and 50 g for spas (10 m³). The weight fraction of substance was set to 0.025 as during mixing and loading pure substance was dissolved in 10 L water. Exposure frequency was taken from the Disinfectant Products Fact Sheet/ product information and set at 122 times a year for outdoor swimming pools and 1 time a week for indoor swimming pools as well as spas. Exposure duration of 5 minutes was taken from the Disinfectant Products Fact Sheet. An instantaneous release was assumed for inhalation exposure, instant application contact for dermal exposure and oral intake was considered not applicable (Disinfectant Products Fact Sheet). Room volume was set to a minimum of 1 m³. Body weight was set to 60 kg (general public), exposed dermal area to 1900 cm² (hands and forearms) and inhalation set to light exercise. Defaults and adjusted parameters for the ConsExpo scenarios as well as results are shown below: Application – Indoor pool General Exposure Data exposure frequency body weight

1 60

1/week kilogram

Inhalation model: Exposure to vapour : instantaneous release weight fraction compound exposure duration room volume ventilation rate applied amount

0.025 5 1 0.6 250

fraction minute m3 1/hr gram Page 191 of 323 93/119

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Uptake model: Fraction uptake fraction inhalation rate Dermal model: Direct dermal contact with product : instant application weight fraction compound exposed area applied amount Uptake model: fraction uptake fraction

SCC Project No. 375-007 12 November 2010

1 32.9

fraction m3/day

0.025 1.9E3 0.5

fraction cm2 gram

1

fraction

Following results were obtained for: application - indoors pool Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 mg/m3 7.55E-22 mg/m3 1.08E-22 mg/m3/day 4.14E-22 mg/kg 5.92E-23 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.00658 mg/cm2 0.208 mg/kg 0.208 mg/kg 0.0298 mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

0.208 mg/kg 0.208 mg/kg 0.0298 mg/kg/day

Application – outdoor pool General Exposure Data exposure frequency body weight

122 60

1/year kilogram

Inhalation model: Exposure to vapour : instantaneous release weight fraction compound exposure duration room volume ventilation rate applied amount

0.025 5 1 0.6 250

fraction minute m3 1/hr gram

Uptake model: Fraction uptake fraction inhalation rate

1 32.9

fraction m3/day

Dermal model: Direct dermal contact with product : instant application weight fraction compound 0.025 exposed area 1.9E3 applied amount 0.5

fraction cm2 gram

Uptake model: fraction uptake fraction

fraction

1

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Following results were obtained for application – outdoor pool Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 7.55E-22 2.52E-22 4.14E-22 1.38E-22

mg/m3 mg/m3 mg/m3/day mg/kg mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.00658 0.208 0.208 0.0696

mg/cm2 mg/kg mg/kg mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

0.208 0.208 0.0696

mg/kg mg/kg mg/kg/day

General Exposure Data exposure frequency body weight

1 60

1/week kilogram

Inhalation model: Exposure to vapour : instantaneous release weight fraction compound exposure duration room volume ventilation rate applied amount

0.025 5 1 0.6 250

fraction minute m3 1/hr gram

Uptake model: Fraction uptake fraction inhalation rate

1 32.9

fraction m3/day

Application – Spa

Dermal model: Direct dermal contact with product : instant application weight fraction compound 0.025 exposed area 1.9E3 applied amount 0.5

fraction cm2 gram

Uptake model: fraction uptake fraction

fraction

1

Following results were obtained for application – spa Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 mg/m3 7.55E-22 mg/m3 1.08E-22 mg/m3/day 4.14E-22 mg/kg 5.92E-23 mg/kg/day

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Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.00658 mg/cm2 0.208 mg/kg 0.208 mg/kg 0.0298 mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

0.208 mg/kg 0.208 mg/kg 0.0298 mg/kg/day

Post application The standard parameters for PC 37 “post application” were taken the RIVM ConsExpo Disinfectant Products Fact Sheet (2006) and adjusted for consumer applications. All calculations reflect a worst-case tier II approach. Substance degradation was not considered during the scenario. Post application exposures were calculated for adults and for children. The worst-case adult scenario assumed swimming 6 times a week for 6 hours (indoor swimming pool) and 122 times per year in outdoors swimming pool. Worst-case use of spas assumed daily use for 60 minutes. Adult body weight was set at 60 kg and child body weight at 10 kg, with body surface areas of 17500 cm² and 4800 cm², respectively (ECETOV TRA, 2009). The amount of total product applied to the skin was adjusted accordingly (100 % adult, 50 % child, i.e. 17500 g and 8750 g of total product applied to the skin). The inhalation rate was set for light activity. Room volume was set to a minimum of 1 m³. A weight fraction compound of 5E-6 was calculated, based on dilution of 250 g in 50 m³. For inhalation and oral uptake routes uptake fractions were set to 1. For dermal uptake skin permeability was conservatively set at 0.001 (EPA Dermal exposure assessment interim report, 1992). Defaults and adjusted parameters for the ConsExpo scenarios (adult and child) as well as results are shown below: Post application – indoor, adult General Exposure Data exposure frequency body weight

1 60

1/day kilogram

Inhalation model: Exposure to vapour : instantaneous release weight fraction compound exposure duration room volume ventilation rate applied amount

5E-6 6 1 0.6 250

fraction hour m3 1/hr gram

Uptake model: Fraction uptake fraction inhalation rate

1 32.9

fraction m3/day

Dermal model: Direct dermal contact with product : instant application weight fraction compound 5E-6 exposed area 1.75E4 applied amount 1.75E4

fraction cm2 gram

Uptake model: diffusion skin permeability compound concentration

cm/hr g/cm3

0.001 5E-6

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exposure time Oral model: Oral exposure to product : constant rate weight fraction compound ingestion rate exposure time Uptake model: Fraction uptake fraction

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6

hour

5E-6 13.8 6

fraction mg/sec hour

1

fraction

Following results were obtained for post application – indoor, adult: Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 mg/m3 5.44E-20 mg/m3 5.44E-20 mg/m3/day 2.98E-20 mg/kg 2.98E-20 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.005 mg/cm2 1.46 mg/kg 0.00872 mg/kg 0.00872 mg/kg/day

Oral : point estimates oral external dose : oral acute (internal) dose : oral chronic (internal) dose :

0.0249 mg/kg 0.0249 mg/kg 0.0249 mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

1.48 mg/kg 0.0336 mg/kg 0.0336 mg/kg/day

Post application – indoor, child General Exposure Data exposure frequency body weight

1 10

1/day kilogram

Inhalation model: Exposure to vapour : instantaneous release weight fraction compound exposure duration room volume ventilation rate applied amount

5E-6 60 1 0.6 250

fraction minute m3 1/hr gram

Uptake model: Fraction uptake fraction inhalation rate

1 10.3

fraction m3/day

Dermal model: Direct dermal contact with product : instant application weight fraction compound 5E-6 exposed area 4.8E3 applied amount 8.75E3

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Uptake model: diffusion skin permeability compound concentration exposure time

0.001 5E-6 60

cm/hr g/cm3 minute

Oral model: Oral exposure to product : constant rate weight fraction compound ingestion rate exposure time

5E-6 13.8 60

fraction mg/sec minute

Uptake model: Fraction uptake fraction

1

fraction

Following results were obtained for post application – indoor, child: Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 mg/m3 9.06E-21 mg/m3 9.06E-21 mg/m3/day 9.31E-21 mg/kg 9.31E-21 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.00911 mg/cm2 4.38 mg/kg 0.0024 mg/kg 0.0024 mg/kg/day

Oral : point estimates oral external dose : oral acute (internal) dose : oral chronic (internal) dose :

0.0249 mg/kg 0.0249 mg/kg 0.0249 mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

4.4 mg/kg 0.0273 mg/kg 0.0273 mg/kg/day

Post application – outdoor, adult General Exposure Data exposure frequency body weight Inhalation model: Exposure to vapour : instantaneous release weight fraction compound exposure duration room volume ventilation rate applied amount Uptake model: Fraction uptake fraction inhalation rate

122 60

1/year kilogram

5E-6 6 1 0.6 250

fraction hour m3 1/hr gram

1 32.9

fraction m3/day

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weight fraction compound exposed area applied amount Uptake model: diffusion skin permeability compound concentration exposure time Oral model: Oral exposure to product : constant rate weight fraction compound ingestion rate exposure time Uptake model: Fraction uptake fraction

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5E-6 1.75E4 1.75E4

fraction cm2 gram

0.001 5E-6 6

cm/hr g/cm3 hour

5E-6 13.8 6

fraction mg/sec hour

1

fraction

Following results were obtained for post application – outdoor, adult: Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose : Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose : Oral : point estimates oral external dose : oral acute (internal) dose : oral chronic (internal) dose : Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

2.17E-19 mg/m3 5.44E-20 mg/m3 1.82E-20 mg/m3/day 2.98E-20 mg/kg 9.97E-21 mg/kg/day 0.005 mg/cm2 1.46 mg/kg 0.00872 mg/kg 0.00291 mg/kg/day 0.0249 mg/kg 0.0249 mg/kg 0.00832 mg/kg/day 1.48 mg/kg 0.0336 mg/kg 0.0112 mg/kg/day

Post application – outdoor, child General Exposure Data exposure frequency body weight

122 10

1/year kilogram

Inhalation model: Exposure to vapour : instantaneous release weight fraction compound exposure duration room volume ventilation rate applied amount

5E-6 60 1 0.6 250

fraction minute m3 1/hr gram

Uptake model: Fraction uptake fraction inhalation rate

1 10.3

fraction m3/day

Dermal model: Direct dermal contact with product : instant application weight fraction compound 5E-6

fraction Page 197 of 323 99/119

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exposed area applied amount

4.8E3 8.75E3

cm2 gram

Uptake model: diffusion skin permeability compound concentration exposure time

0.001 5E-6 60

cm/hr g/cm3 minute

Oral model: Oral exposure to product : constant rate weight fraction compound ingestion rate exposure time

5E-6 13.8 60

fraction mg/sec minute

Uptake model: Fraction uptake fraction

1

fraction

Following results were obtained for post application – outdoor, child: Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 mg/m3 9.06E-21 mg/m3 3.03E-21 mg/m3/day 9.31E-21 mg/kg 3.11E-21 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.00911 mg/cm2 4.38 mg/kg 0.0024 mg/kg 0.000801 mg/kg/day

Oral : point estimates oral external dose : oral acute (internal) dose : oral chronic (internal) dose :

0.0249 mg/kg 0.0249 mg/kg 0.00832 mg/kg/day

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

4.4 mg/kg 0.0273 mg/kg 0.00912 mg/kg/day

Post application – Spa, adult General Exposure Data exposure frequency body weight

1 60

1/day kilogram

Inhalation model: Exposure to vapour : instantaneous release weight fraction compound exposure duration room volume ventilation rate applied amount

5E-6 60 1 0.6 250

fraction minute m3 1/hr gram

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Uptake model: Fraction uptake fraction inhalation rate

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1 32.9

fraction m3/day

Dermal model: Direct dermal contact with product : instant application weight fraction compound 5E-6 exposed area 1.75E4 applied amount 1.75E4

fraction cm2 gram

Uptake model: diffusion skin permeability compound concentration exposure time

0.001 5E-6 60

cm/hr g/cm3 minute

Oral model: Oral exposure to product : constant rate weight fraction compound ingestion rate exposure time

5E-6 13.8 60

fraction mg/sec minute

Uptake model: Fraction uptake fraction

1

fraction

Following results were obtained for post application – spa, adult: Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 mg/m3 9.06E-21 mg/m3 9.06E-21 mg/m3/day 4.97E-21 mg/kg 4.97E-21 mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.005 mg/cm2 1.46 mg/kg 0.00146 mg/kg 0.00146 mg/kg/day

Oral : point estimates oral external dose : oral acute (internal) dose : oral chronic (internal) dose :

0.00415 0.00415 0.00415

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

1.46 mg/kg 0.00561 mg/kg 0.00561 mg/kg/day

mg/kg mg/kg mg/kg/day

Post application – spa, child General Exposure Data exposure frequency body weight

1 10

1/day kilogram

Inhalation model: Exposure to vapour : instantaneous release weight fraction compound

5E-6

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exposure duration room volume ventilation rate applied amount

60 1 0.6 250

minute m3 1/hr gram

Uptake model: Fraction uptake fraction inhalation rate

1 10.3

fraction m3/day

Dermal model: Direct dermal contact with product : instant application weight fraction compound 5E-6 exposed area 4.8E3 applied amount 8.75E3

fraction cm2 gram

Uptake model: diffusion skin permeability compound concentration exposure time

0.001 5E-6 60

cm/hr g/cm3 minute

Oral model: Oral exposure to product : constant rate weight fraction compound ingestion rate exposure time

5E-6 13.8 60

fraction mg/sec minute

Uptake model: Fraction uptake fraction

1

fraction

Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

2.17E-19 9.06E-21 9.06E-21 9.31E-21 9.31E-21

mg/m3 mg/m3 mg/m3/day mg/kg mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

0.00911 4.38 0.0024 0.0024

mg/cm2 mg/kg mg/kg mg/kg/day

Oral : point estimates oral external dose : oral acute (internal) dose : oral chronic (internal) dose :

0.0249 0.0249 0.0249

mg/kg mg/kg mg/kg/day

4.4 0.0273

mg/kg mg/kg

0.0273

mg/kg/day

Following results were obtained for post application – spa, child:

Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

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PC 39 (Cosmetics, personal care products) The standard parameters for PC 39 to estimate exposure to persulfates used in hair bleaching were taken from the RIVM ConsExpo Cosmetics Fact Sheet (2006), product category “Hair care cosmetics – hair bleach” and adjusted for consumer applications. All calculations reflect a worstcase tier II approach. Substance degradation was not considered during the scenario. Exposure frequency, exposure duration, product amount, weight fraction compound and room volume and ventilation rate were taken from the ConsExpo Cosmetics Fact Sheet (2008). The body weight was set to 60 kg (general public), exposed dermal area to 580 cm² (half area head) and inhalation rates were increased to light exercise. For uptake via the inhalation route the fraction was set at 1.0. For dermal uptake gloves were assumed providing 90 % protection resulting in a fraction of 0.1. Defaults and adjusted parameters for the ConsExpo scenarios are shown below: General Exposure Data exposure frequency body weight

10 60

1/year kilogram

Inhalation model: Exposure to vapour : constant rate weight fraction compound exposure duration room volume ventilation rate applied amount release duration

0.08 45 10 2 200 15

fraction minute m3 1/hr gram minute

Uptake model: Fraction uptake fraction inhalation rate

1 24.1

fraction litre/min

Dermal model: Direct dermal contact with product : instant application weight fraction compound 0.08 exposed area 580 applied amount 200

fraction cm2 gram

Uptake model: fraction uptake fraction

0.1

fraction

Inhalation (point estimates) inhalation mean event concentration : inhalation mean concentration on day of exposure: inhalation air concentration year average : inhalation acute (internal) dose : inhalation chronic (internal) dose :

757 23.7 0.648 13.7 0.375

mg/m3 mg/m3 mg/m3/day mg/kg mg/kg/day

Dermal : point estimates dermal load : dermal external dose : dermal acute (internal) dose : dermal chronic (internal) dose :

27.6 267 26.7 0.73

mg/cm2 mg/kg mg/kg mg/kg/day

Following results were obtained for cosmetics, hair care products:

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Integrated (point estimates) total external dose: total acute dose (internal): total chronic dose (internal):

280 40.4 1.1

mg/kg mg/kg mg/kg/day

9.5.2.2.1 Short term (acute) exposure For Use 4 product categories exposures to consumers were calculated using ConsExpo (v4.1). All relevant routes of exposure were considered, including the dermal and inhalation route and, if applicable, the oral route. Short term (acute) exposure concentrations are shown in the table below. Table 133

Short term (acute) exposure concentrations to consumers (Use 4 Consumer use)

Routes of exposure PC 14 (metal surface treatment) - adult

Concentrations

Justification

Dermal local exposure (in mg/cm2)

0.172

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.617

ConsExpo

Inhalation exposure (in mg/m3)

8.43E-22

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.617

ConsExpo

Dermal local exposure (in mg/cm2)

0.172

ConsExpo

Dermal systemic exposure (in mg/kg bw)

3.7

ConsExpo

Inhalation exposure (in mg/m3)

8.43E-22

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

3.7

ConsExpo

PC 14 (metal surface treatment) - child

PC 37 (water treatment chemicals) - mixing and loading – indoor pool Dermal local exposure (in mg/cm2)

2.31E-5

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.000732

ConsExpo

Inhalation exposure (in mg/m )

8.15E-29

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.000731

ConsExpo

3

PC 37 (water treatment chemicals) - mixing and loading – outdoor pool 2

Dermal local exposure (in mg/cm )

9.14E-5

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.000732

ConsExpo

Inhalation exposure (in mg/m )

2.01E-22

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.000731

ConsExpo

3

PC 37 (water treatment chemicals) - mixing and loading – spa Dermal local exposure (in mg/cm2)

9.14E-5

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.000732

ConsExpo

Inhalation exposure (in mg/m )

0.000732

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.000731

ConsExpo

3

PC 37 (water treatment chemicals) - application – indoor pool 2

Dermal local exposure (in mg/cm )

0.00658

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.208

ConsExpo

Inhalation exposure (in mg/m3)

7.55E-22

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.208

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Routes of exposure Concentrations PC 37 (water treatment chemicals) - application – outdoor pool

Justification

Dermal local exposure (in mg/cm2)

0.00658

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.208

ConsExpo

Inhalation exposure (in mg/m )

7.55E-22

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.208

ConsExpo

3

PC 37 (water treatment chemicals) - application – spa Dermal local exposure (in mg/cm2)

0.00658

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.208

ConsExpo

Inhalation exposure (in mg/m3)

7.55E-22

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.208

ConsExpo

PC 37 (water treatment chemicals) – post application – indoors - adult Dermal local exposure (in mg/cm2)

0.005

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.00872

ConsExpo

Inhalation exposure (in mg/m3)

5.44E-20

ConsExpo

Oral systemic exposure (in mg/kg bw)

0.0249

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.0336

ConsExpo

PC 37 (water treatment chemicals) – post application – indoors - child Dermal local exposure (in mg/cm2)

0.00911

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.0024

ConsExpo

Inhalation exposure (in mg/m )

9.06E-21

ConsExpo

Oral systemic exposure (in mg/kg bw)

0.0249

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.0273

ConsExpo

3

PC 37 (water treatment chemicals) – post application – outdoors - adult Dermal local exposure (in mg/cm2)

0.005

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.00872

ConsExpo

Inhalation exposure (in mg/m )

5.44E-20

ConsExpo

Oral systemic exposure (in mg/kg bw)

0.0249

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.0112

ConsExpo

3

PC 37 (water treatment chemicals) – post application – outdoors - child Dermal local exposure (in mg/cm2)

0.00911

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.0024

ConsExpo

Inhalation exposure (in mg/m )

9.06E-21

ConsExpo

Oral systemic exposure (in mg/kg bw)

0.0249

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.0273

ConsExpo

3

PC 37 (water treatment chemicals) – post application – spa - adult Dermal local exposure (in mg/cm2)

0.005

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.00146

ConsExpo

Inhalation exposure (in mg/m )

9.06E-21

ConsExpo

Oral systemic exposure (in mg/kg bw)

0.00415

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.00561

ConsExpo

3

PC 37 (water treatment chemicals) – post application – spa - child Dermal local exposure (in mg/cm2)

0.00911

ConsExpo

Dermal systemic exposure (in mg/kg bw)

0.0024

ConsExpo

Inhalation exposure (in mg/m )

9.06E-21

ConsExpo

Oral systemic exposure (in mg/kg bw)

0.0249

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

0.0273

ConsExpo

3

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Routes of exposure PC 39 (cosmetics, personal care products)

Concentrations

Justification

Dermal local exposure (in mg/cm2)

27.6

ConsExpo

Dermal systemic exposure (in mg/kg bw)

26.7

ConsExpo

Inhalation exposure (in mg/m )

23.7

ConsExpo

Oral systemic exposure (in mg/kg bw)

NA

ConsExpo

Total acute dose (internal) dose (mg/kg bw)

40.4

ConsExpo

3

Summary of Acute/short term exposure concentrations to consumers The following table summarizes worst-case acute/short term exposure concentrations to consumers for each exposure route, as calculated by ConsExpo (v4.1). Table 134

Summary of short term (acute) exposure concentrations to consumers (Use 4 Consumer Use)

Routes of exposure Dermal local exposure (in mg/cm2)

Concentrations 27.6

Justification ConsExpo (v4.1)

Dermal systemic exposure (in mg/kg bw)

26.7

ConsExpo (v4.1)

Inhalation exposure (in mg/m3)

23.7

ConsExpo (v4.1)

Oral exposure (in mg/kg bw)

0.0249

ConsExpo (v4.1)

Total acute dose (internal) dose (mg/kg bw)

40.4

ConsExpo (v4.1)

Use 4 Consumer worst-case exposure concentrations were calculated using ConsExpo (v4.1). Highest dermal, inhalation and total acute exposure concentrations were calculated for PC 39 with concentrations of 26.7 mg/kg bw for dermal exposure, 25.9 mg/m³ for inhalation exposure and 40.4 mg/kg bw for total acute dose. Highest oral exposure concentration of 0.0249 mg/kg bw was calculated for PC 37 and exposure post application to child. 9.5.2.2.2

Long term (chronic) exposure

For Use 4 product categories exposures to consumers were calculated using ConsExpo (v4.1). All relevant routes of exposure were considered, including the dermal and inhalation route and, if applicable, the oral route. Long term dermal local exposure is not applicable. Relevant long term (chronic) exposure calculations are shown in the table below. Table 135

Long term (chronic) exposure concentrations to consumers (Use 4 Consumer use)

Routes of exposure PC 14 (metal surface treatment) - adult

Concentrations

Justification

Dermal local exposure (in mg/cm2)

0.172

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.263

ConsExpo

Inhalation exposure (in mg/m /day)

3.6E-22

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.263

ConsExpo

Dermal local exposure (in mg/cm2)

0.172

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

1.58

ConsExpo

Inhalation exposure (in mg/m /day)

3.6E-22

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

1.58

ConsExpo

3

PC 14 (metal surface treatment) - child

3

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Routes of exposure Concentrations PC 37 (water treatment chemicals) - mixing and loading – indoors pool

Justification

Dermal local exposure (in mg/cm2)

2.31E-5

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.000105

ConsExpo

Inhalation exposure (in mg/m /day)

1.16E-29

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.000105

ConsExpo

3

PC 37 (water treatment chemicals) - mixing and loading – outdoors pool Dermal local exposure (in mg/cm2)

9.14E-5

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.000244

ConsExpo

Inhalation exposure (in mg/m3/day)

0.000244

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.000244

ConsExpo

PC 37 (water treatment chemicals) - mixing and loading – spa Dermal local exposure (in mg/cm2)

9.14E-5

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.000105

ConsExpo

Inhalation exposure (in mg/m3/day)

2.87E-23

ConsExpo

Oral systemic exposure (in mg/kg bw/day

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.000105

ConsExpo

PC 37 (water treatment chemicals) - application – indoors pool Dermal local exposure (in mg/cm2)

0.00658

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.0298

ConsExpo

Inhalation exposure (in mg/m /day)

1.08E-22

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.0298

ConsExpo

3

PC 37 (water treatment chemicals) - application – outdoors pool Dermal local exposure (in mg/cm2)

0.00658

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.0696

ConsExpo

Inhalation exposure (in mg/m /day)

2.52E-22

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.0696

ConsExpo

Dermal local exposure (in mg/cm2)

0.00658

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.0298

ConsExpo

Inhalation exposure (in mg/m /day)

1.08E-22

ConsExpo

Oral systemic exposure (in mg/kg bw/day

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.0298

ConsExpo

3

PC 37 (water treatment chemicals) - application – spa

3

PC 37 (water treatment chemicals) – post application – indoors - adult Dermal local exposure (in mg/cm2)

0.005

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.00872

ConsExpo

Inhalation exposure (in mg/m /day)

5.44E-20

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

0.0249

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.0336

ConsExpo

3

PC 37 (water treatment chemicals) – post application – indoors - child Dermal local exposure (in mg/cm2)

0.00911

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.0024

ConsExpo

Inhalation exposure (in mg/m /day9

9.06E-21

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

0.0249

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.0273

ConsExpo

3

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Routes of exposure Concentrations PC 37 (water treatment chemicals) – post application – outdoors - adult

Justification

Dermal local exposure (in mg/cm2)

0.005

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.00291

ConsExpo

Inhalation exposure (in mg/m /day)

1.82E-20

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

0.00832

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.0112

ConsExpo

3

PC 37 (water treatment chemicals) – post application – outdoors - child Dermal local exposure (in mg/cm2)

0.00911

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.000801

ConsExpo

Inhalation exposure (in mg/m3/day)

3.03E-21

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

0.00832

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.00912

ConsExpo

PC 37 (water treatment chemicals) – post application – spa - adult Dermal local exposure (in mg/cm2)

0.005

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.00146

ConsExpo

Inhalation exposure (in mg/m3/day)

9.06E-21

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

0.00415

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.00561

ConsExpo

PC 37 (water treatment chemicals) – post application – spa - child Dermal local exposure (in mg/cm2)

0.00911

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.0024

ConsExpo

Inhalation exposure (in mg/m /day)

9.06E-21

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

0.0249

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

0.0273

ConsExpo

Dermal local exposure (in mg/cm2)

27.6

ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.73

ConsExpo

Inhalation exposure (in mg/m /day)

0.375

ConsExpo

Oral systemic exposure (in mg/kg bw/day)

NA

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

1.10

ConsExpo

3

PC 39 (cosmetics, personal care products)

3

Summary of long term exposure concentrations to consumers The following table summarizes worst-case long term exposure concentrations to consumers for each exposure route, as calculated by ConsExpo (v4.1). Table 136

Summary of long term exposure concentrations to consumers

Routes of exposure Dermal local exposure (in mg/cm2/day)

Concentrations 27.6

Justification ConsExpo

Dermal systemic exposure (in mg/kg bw/day)

0.73

ConsExpo

Inhalation exposure (in mg/m3/day)

0.375

ConsExpo

Oral exposure (in mg/kg bw/day)

0.0249

ConsExpo

Total chronic dose (internal) dose (mg/kg bw/day)

1.10

ConsExpo

Use 4 Consumer worst-case exposure concentrations were calculated using ConsExpo (v4.1). Highest dermal, inhalation and total acute exposure concentrations were calculated for PC 39 with exposure concentrations of 0.73 mg/kg bw for dermal exposure and 0.375 mg/m³ for inhalation exposure and 1.10 mg/kg bw for total exposure. Highest oral exposure concentration of 0.0249 mg/kg bw was calculated for PC 37 and exposure post application to child. Page 206 of 323 108/119

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9.5.2.3 Indirect exposure of humans via the environment (oral) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (see Annex II). Specific ERC release values were installed in the EUSES model. A reduction of 99.9 % emission to air and 99.9 % reduction of emission to wastewater was assumed by e.g. local exhaust ventilation with incineration of filters and waste water treatment. Direct release to soil was considered not applicable. Normally there is no waste, as batches out of specifications are blended. If this is not possible, wastes such as cleaning solutions collected and disposed of as hazardous waste according to official regulations. The following table shows the specific ERC used. Table 137

ECETOC TRA scenario (Use 4 Consumer use)

Environmental Release Category (ERC) ERC 8b ERC 8e

Description Wide dispersive indoor use of reactive substances in open systems Wide dispersive outdoor use of reactive substances in open systems

The following table shows the indirect exposure of humans via the environment. Table 138

Concentration for oral exposure of humans via the environment

ERC

8b 8b 8b 8b 8b 8b 8b 8b 8e 8e 8e 8e 8e 8e 8e 8e

Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose Wet fish Drinking water Meat Leafy crops Root crops Milk Air Total dose

Estimated exposure concentrations value unit 7.48E-05 mg/kg/day 9.21E-04 mg/L/day 6.54E-09 mg/kg/day 3.95E-05 mg/kg/day 2.39E-05 mg/kg/day 1.22E-07 mg/kg/day 7.45E-11 mg/m3 1.06E-03 mg/kg/day 7.48E-05 mg/kg/day 9.21E-04 mg/L/day 6.54E-09 mg/kg/day 3.95E-05 mg/kg/day 2.39E-05 mg/kg/day 1.22E-07 mg/kg/day 3 7.45E-11 mg/m 1.06E-03 mg/kg/day

Measured exposure concentrations value unit ---------------------------------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 4 Private use ERC 8b and ERC 8e calculated total daily concentrations for indirect exposure of humans via the environment were 1.06E-03 mg/kg/day, respectively. The following table shows total daily doses for oral exposure of humans via the environment.

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Table 139

SCC Project No. 375-007 12 November 2010

Total daily dose for oral exposure of humans via the environment

Total daily dose for oral exposure via the environment (mg/kg bw/d) ERC Exposed via local Exposed via local and regional concentration concentration 8b 1.06E-03 1.42E-03 8e 1.06E-03 1.42E-03

Justification

EUSES (v2.1) EUSES (v2.1)

For Use 4 Private use ERC 8b and ERC 8c the total daily doses for oral exposure of humans via the environment were 1.06E-03 mg/kg/day, respectively. The regional total daily concentration was 1.42E 04 mg/kg/day (see section 9.6). 9.5.2.4 Environmental exposure (Use 4 Private use) The following table shows environmental release categories (ERCs; tier I and tier ll), according to ECHA CSA R12 (2009). Tier I calculations were performed using ECETOC TRA (see Annex I). Tier lI calculations were performed using EUSES (see Annex II). Specific ERC release values were installed in the EUSES model. The following table shows the specific ERCs used. Table 140

ECETOC TRA scenario (Use 4 Consumer use)

Environmental Release Category (ERC) ERC 8b ERC 8e

Description Wide dispersive indoor use of reactive substances in open systems Wide dispersive outdoor use of reactive substances in open systems

The following section shows tier II exposure assessment results. 9.5.2.4.1 Environmental releases The following table shows estimated releases to relevant compartments of the environment. No measured data was available. Data was calculated by EUSES (v2.1; Annex II). Table 141

Releases to the environment (local)

ERC

Compartments

8b 8b 8b 8b 8b 8e 8e 8e 8e 8e

Air Waste water Surface water Industrial soil Agricultural soil Air Waste water Surface water Industrial soil Agricultural soil

Predicted releases 0 kg/day 0.438 kg/day ---0 kg/day 0.438 kg/day ----

Measured release (kg/d) -----------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 4 Private use ERC 8b and ERC 8e estimated maximal released amount waste water was 0.438 kg/day, respectively. The following table shows estimated point source releases and estimated total releases for regional exposures. All relevant compartments were taken into account for exposure estimations.

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Table 142

SCC Project No. 375-007 12 November 2010

Summary of the releases to the environment

ERC

Compartments

8b 8b 8b 8b 8e 8e 8e 8e

Air Wastewater Surface water Industrial soil Air Wastewater Surface water Industrial soil

Release from point source (local exposure estimation) 0 kg/day 0.438 kg/day --0 kg/day 0.438 kg/day ---

Total release for regional exposure estimation

Justification

11 kg/day 219 kg/day 0 kg/day 0 kg/day 11 kg/day 219 kg/day 0 kg/day 0 kg/day

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 4 Private use local release value to air for ERC 8b and 8e was 0.438 kg/day, respectively. Total regional releases were 11 kg/day to air and 219 kg/day to wastewater, respectively. Release values were used for calculation of environmental compartment predicted environmental concentrations. 9.5.2.4.2

Exposure concentration in sewage treatment plants (STP)

The following table shows estimated concentrations in waste water. Only estimated data calculated by EUSES 2.1 (Annex II) was available. No monitoring data was available. Table 143

Concentrations in sewage (Use 4 Private use)

ERC

Compartments

Measured exposure concentrations

Explanation / source of measured data

Sewage (STP effluent)

Estimated exposure concentrations value unit 0.219 mg/L

8b

value --

unit --

EUSES (v2.1)

8b

Sewage sludge

0.219

mg/kg

--

--

EUSES (v2.1)

8e

Sewage (STP effluent)

0.219

mg/L

--

--

EUSES (v2.1)

8e

Sewage sludge

0.219

mg/kg

--

--

EUSES (v2.1)

For Use 4 Private use ERC 8b and ERC 8e concentrations in sewage effluent and sewage sludge were 0.219 mg/kg and 0.219 mg/L, respectively. The following table summarises exposure concentrations in sewage treatment plants. Table 144 ERC 8b 8b 8b 8e 8e 8e

Predicted Exposure Concentrations (PEC) in sewage (Use 3 Professional use)

Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw) Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw) Concentration in sewage (PECSTP; mg/L) Concentration in sewage sludge (mg/kg dw)

Value 0.219 0.219 0.219 0.219 0.219 0.219

Justification EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

For Use 4 Private use ERC 8b and 8e predicted effect concentrations in sewage and concentrations in sewage sludge were 0.219 mg/L and 0.219 mg/kg, respectively.

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9.5.2.4.3

SCC Project No. 375-007 12 November 2010

Exposure concentration in aquatic pelagic compartment

The exposure in aquatic pelagic compartment was calculated by EUSES 2.1 (Annex II). The following table shows estimated concentrations for freshwater and marine compartments. No monitoring data was available. Table 145

Local concentrations in water (Use 4 Private use)

ERC

Compartments

8b

Freshwater

8b

8b 8e

8e

8e

Marine water

Intermittent releases to water Freshwater

Marine water

Intermittent releases to water

Estimated exposure concentrations value 0.0219

unit mg/L

Measured local exposure concentrations value unit ---

0.0104 0.0322

mg/L mg/L

---

---

-2.19E-03

-mg/L

---

---

9.66E-04 3.16E-03

mg/L mg/L

---

---

---

---

---

---

0.0219

mg/L

--

--

0.0104 0.0322

mg/L mg/L

---

---

-2.19E-03

-mg/L

---

---

9.66E-04 3.16E-03

mg/L mg/L

---

---

---

---

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available No intermittent releases to water Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available Estimated local exposure concentration based on EUSES calculation. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available No intermittent releases to water

For Use 4 Private use ERC 8b and ERC 8e local estimated predicted exposure concentrations in freshwater and marine water were 0.0219 mg/L and 2.19E-03 mg/L, respectively. Regional estimated predicted exposure concentrations in freshwater and marine water were 0.0104 mg/L and 9.66E 04 mg/L, respectively. The following table shows summarized PEC-values for aquatic compartments.

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Table 146

SCC Project No. 375-007 12 November 2010

Predicted Exposure Concentrations (PEC) in aquatic compartment (Use 4 Private use)

ERC

Compartments Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

Local concentration 0.0219 2.19E-03 --

PEC aquatic (local+regional) 0.0322 3.16E-03 --

8b 8b 8b 8e 8e 8e

Freshwater (in mg/L) Marine water (in mg/L) Intermittent releases to water (in mg/L)

0.0219 2.19E-03 --

0.0322 3.16E-03 --

Justification EUSES (v2.1) EUSES (v2.1) No intermittent releases to water EUSES (v2.1) EUSES (v2.1) No intermittent releases to water

For Use 4 Private use all PEC-values in freshwater and marine water were 0.0322 mg/L and 3.16E-03 mg/L, respectively. PEC-values were used for risk characterisation. 9.5.2.4.4

Exposure concentration in sediments

The following table shows estimated exposure concentrations for sediments calculated by EUSES 2.1 (Annex II). No monitoring data was available. Table 147

Local concentrations in sediment (Use 4 Private use)

ERC

Compartments

8b

Freshwater sediments

8b

8e

8e

Marine water sediments

Freshwater sediments

Marine water sediments

Estimated exposure concentrations value --

unit --

Measured local exposure concentrations value unit ---

7.09E-03 0.0274

mg/kg wwt mg/kg wwt

---

---

---

---

---

---

6.69E-04 2.69E-03

mg/kg wwt mg/kg wwt

---

---

---

---

---

---

7.09E-03 0.0274

mg/kg wwt mg/kg wwt

---

---

---

----

---

---

6.69E-04 2.69E-03

mg/kg wwt mg/kg wwt

---

---

--

--

--

--

Explanation / source of measured data

No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. No local exposure concentration calculated by EUSES. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available.

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For Use 4 Private use ERC 8b and ERC 8e PEC-values were 0.0274 mg/kg wwt for freshwater sediments and 2.69E-03 mg/kg wwt for marine water sediments, respectively. The following table shows PEC-values for freshwater and marine sediments. Summarized exposure concentrations in aquatic sediments were taken into account for risk characterisation Table 148

Predicted Exposure Concentrations (PEC) in sediments (Use 4 Private use)

ERC

Compartments

8b

Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt) Freshwater sediments (in mg/kg wwt) Marine water sediments (in mg/kg wwt)

8b 8e 8e

Local concentration --

PEC sediment (local+regional) 0.0274

Justification

--

2.69E-03

EUSES (v2.1)

--

0.0274

EUSES (v2.1)

--

2.69E-03

EUSES (v2.1)

EUSES (v2.1)

For Use 4 Private use ERC 8b and ERC 8e calculated PEC-values in sediments were 0.0274 mg/kg wwt for freshwater sediments and 2.69E-03 mg/kg wwt for marine water sediments, respectively. PEC-values were used for risk characterisation. 9.5.2.4.5

Exposure concentrations in soil and groundwater

The following table shows estimated local concentrations in soil and groundwater calculated by EUSES (Annex 2.1). No monitoring data was available. Table 149 ERC

8b

Local concentrations in soil (Use 4 Private use)

Compartments

Agricultural soil averaged

Estimated exposure concentrations

Measured local exposure concentrations value unit ---

value 2.54E-04

unit mg/kg wwt

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

1.02E-04

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

9.63E-04

8.11E-04

8b

Grassland averaged

2.83E-05

mg/kg wwt

--

--

8b

Groundwater

--

--

--

--

8e

Agricultural soil averaged

2.54E-04

mg/kg wwt

--

--

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation for average 30 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES. Estimated local exposure concentration based on EUSES calculation for average 30 days. Page 212 of 323 114/119

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ERC

Compartments

SCC Project No. 375-007 12 November 2010

Estimated exposure concentrations value 5.26E-04 9.63E-04

unit mg/kg wwt mg/kg wwt

Measured local exposure concentrations value unit ---

Explanation / source of measured data

--

--

Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (30 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation for average 180 days. Regional concentration

1.02E-04

mg/kg wwt

--

--

5.26E-04

mg/kg wwt mg/kg wwt

--

--

--

--

8.11E-04

8e

Grassland averaged

2.83E-05

mg/kg wwt

--

--

8e

Groundwater

--

--

--

--

Regional concentration

Estimated predicted exposure concentration (PEC) = estimated local exposure concentration (180 days) + regional concentration. Estimated local exposure concentration based on EUSES calculation. No local exposure concentration was calculated by EUSES.

For Use 4 Private use ERC 8b and 8e estimated concentrations were 2.54E-04 mg/kg wwt for agricultural soil averaged over 30 days, 1.02E-04 mg/kg wwt for agricultural soil averaged over 180 days and 2.83E-05 mg/kg wwt for grassland, respectively. The following table shows PEC-values for soil and groundwater. Table 150

Predicted Exposure Concentrations (PEC) in soil and groundwater (Use 4 Private use)

ERC 8b

8b 8b 8e

8e 8e

Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L) Agricultural soil 30days averaged 180 days (mg/kg wwt) Grassland averaged (mg/kg wwt) Groundwater (mg/L)

Local concentration 2.54E-04 1.02E-04

PEC soil/groundwater (local + regional) 9.63E-04 8.11E-04

Justification

2.83E-05 -2.54E-04 1.02E-04

7.38E-04 4.68E-03 9.63E-04 8.11E-04

EUSES (v2.1) EUSES (v2.1) EUSES (v2.1) EUSES (v2.1)

2.83E-05 --

7.83E-04 4.68E-03

EUSES (v2.1) EUSES (v2.1)

EUSES (v2.1) EUSES (v2.1)

For Use 4 Private use ERC 8b and 8e calculated PEC-values were 9.63E-04 mg/kg wwt for agricultural soil averaged over 30 days, 8.11E-04 mg/kg wwt for agricultural soil averaged over 180 days, 7.38E-04 mg/kg wwt for grassland and 4.68E-03 mg/L for groundwater, respectively. 9.5.2.4.6

Atmospheric compartment

The following table shows estimated local concentrations in air calculated by EUSES (v2.1, Annex II).

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Table 151

Local concentrations in air (Use 4 Private use)

ERC

8b

Estimated exposure concentrations

During emission

8b

Annual average

8b

Annual total deposition

8e

During emission

8e

Annual average

8e

SCC Project No. 375-007 12 November 2010

Annual total deposition

value 2.24E-10

unit mg/m3

Measured local exposure concentrations value unit ---

--

--

--

--

-2.24E-10

-mg/m3

---

---

3.67E-11 2.61E-10

mg/m3 mg/m3

---

---

-8.02E-09

-mg/m2/ day

---

---

2.24E-10

mg/m3

--

--

--

--

--

--

-2.24E-10

-mg/m3

---

---

3.67E-11 2.61E-10

mg/m3 mg/m3

---

---

-8.02E-09

-mg/m2/ day

---

---

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Estimated local exposure concentration based on EUSES calculation. No estimated predicted exposure concentration (PEC) was calculated by EUSES No monitoring data available. Estimated local exposure concentration based on EUSES calculation. Regional concentrations Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration No monitoring data available. Estimated local exposure concentration based on EUSES calculation.

For Use 4 Private use ERC 8b and 8e estimated total emission to the atmospheric compartment was 2.24E-10 mg/m3, the annual average was 2.24E-10 mg/m3 with an annual deposition of 8.02E 09 mg/m2/day, respectively. The following table shows PEC-values for the atmospheric compartment. Table 152

Predicted Exposure Concentration (PEC) in air (Use 4 Private use)

ERC 8b 8b

During emission (mg/m3) Annual average (mg/m3)

8b

Annual deposition (mg/m2/day)

Local concentration 2.24E-10 2.24E-10

PEC air (local + regional) -2.61E-10

Justification

8.02E-09

--

EUSES (v2.1)

EUSES (v2.1) EUSES (v2.1)

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ERC 8e 8e

During emission (mg/m3) Annual average (mg/m3)

8e

Annual deposition (mg/m2/day)

Local concentration 2.24E-10 2.24E-10

PEC air (local + regional) -2.61E-10

Justification

8.02E-09

--

EUSES (v2.1)

EUSES (v2.1) EUSES (v2.1)

For Use 4 Private use ERC 8b and 8e calculated PEC-values for annual average were 2.61E 10 mg/m3, respectively. PEC-values were used for risk characterisation. 9.5.2.4.7

Exposure concentration relevant for the food chain (Secondary poisoning)

The following table shows exposure concentrations relevant for the food chain (secondary poisoning) calculated by EUSES (v2.1, Annex II). No monitoring data was available. Table 153

Local concentration relevant for secondary poisoning (Use 3 Professional use)

ERC

8b

8b

8b 8e

8e

8e

Predicted exposure concentrations

Concentration in food of fish eating predator

Concentration in food of fish eating top-predator (marine)

Concentration in earthworm Concentration in food of fish eating predator

Concentration in food of fish eating top-predator (marine)

Concentration in earthworm

value 0.0301 0.0104 --

unit mg/kg wwt mg/L --

Measured local exposure concentrations value unit -----

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-2.98E-03

-mg/kg

---

---

0.0301

mg/kg wwt mg/L --

--

--

---

---

---

---

9.66E-04 --

-mg/kg wwt mg/L --

---

---

-2.98E-03

-mg/kg

---

---

-1.67E-03

0.0104 --

-1.67E-03

Explanation / source of measured data

Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil Estimated local exposure concentration based on EUSES calculations Regional concentration (surface water) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Estimated local exposure concentration based on EUSES calculations Regional concentration (seawater) Estimated predicted exposure concentration (PEC) = estimated local exposure concentration + regional concentration Measured concentrations Concentration from agricultural soil

For Use 4 Private use ERC 8b and 8e concentrations in food of fish eating predators were 0.0301 mg/kg wwt, concentrations in food of fish eating top-predators (marine) were 1.67E 03 mg/kg wwt, respectively. Concentrations in earthworms were 2.98E-03 mg/kg mg/kg for ERC 8b and 8e. The following table shows PEC-values for secondary poisoning. Page 215 of 323 117/119

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Table 154

Predicted Exposure Concentration in food (PECoral) for secondary poisoning (Use 4 Private use)

ERC 8b 8b 8b 8e 8e 8e

SCC Project No. 375-007 12 November 2010

Local concentration PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt) PECoral predator (in mg/kg wwt) PECoral top predator (in mg/kg wwt) Concentration in earthworm (in mg/kg wwt)

Justification

0.0301

PEC oral (local + regional) 4.05E-02

1.67E-03

2.64E-03

EUSES (v2.1) calculations

2.98E-03

3.51E-02

EUSES (v2.1) calculations

0.0301

4.05E-02

EUSES (v2.1) calculations

1.67E-03

2.64E-03

EUSES (v2.1) calculations

2.98E-03

3.51E-03

EUSES (v2.1) calculations

EUSES (v2.1) calculations

For Use 4 Private use ERC 8b and 8e PECoral-values for top predators were 4.05E-02 mg/kg wwt in freshwater and 2.64E-03 mg/kg wwt in marine environments. Concentrations in earthworms were 3.51E-03 mg/kg for ERC 8b and 8e. PEC-values were used for risk characterisation.

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9.6

SCC Project No. 375-007 12 November 2010

Regional exposure concentrations

The following table shows estimated regional exposure concentrations for the total volume of substance in the environment. No monitoring data was available. Table 155

Freshwater Marine water Freshwater sediments Marine sediments Agricultural soil Grassland Air

Regional concentrations in the environment Predicted regional Exposure Concentrations value unit 0.014 mg/L 9.66E-04 mg/L --7.09E-03 mg/kg wwt --6.69E-04 mg/kg wwt --5.26E-04 mg/kg wwt --NA ---3.67E-11 mg/m3 ---

Measured regional exposure concentrations value unit ---------------------------

Explanation / source of measured data EUSES (v2.1) EUSES (v2.1) No monitoring data available. EUSES (v2.1) No monitoring data available. EUSES (v2.1) No monitoring data available. EUSES (v2.1) No monitoring data available. EUSES (v2.1) No monitoring data available. EUSES (v2.1) No monitoring data available.

Estimated concentrations were 0.014 mg/L in freshwater, 9.66E-04 mg/L in marine water, 7.09E-03 mg/kg wwt in freshwater sediments, 6.69E-04 mg/kg wwt in marine sediments, 5.26E 04 mg/kg wwt in agricultural soil and 3.67E-11 mg/m3 in air. The following table shows estimated regional exposure concentrations for the total volume of the substance in the food and drinking water. No monitoring data was available. Table 156

Wet fish Drinking water Meat Milk

Regional concentrations in drinking water Predicted regional Exposure Concentrations value unit 0.0146 mg/kg --0.0104 mg/L --5.33E-07 mg/kg wwt --5.33E-07 mg/kg wwt ---

Measured regional exposure concentrations value unit -----------------

Explanation / source of measured data EUSES (v2.1) No monitoring data available. EUSES (v2.1) No monitoring data available. EUSES (v2.1) No monitoring data available. EUSES (v2.1) No monitoring data available.

Estimated concentrations were 0.0146 mg/kg in wet fish and drinking water, 5.33E-07 mg/kg wwt in meat and milk.

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