FICHE DE DONNEES DE SECURITE
Transcription
FICHE DE DONNEES DE SECURITE
FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ 1: Identification de la substance/du mélange de la société/l'entreprise 1.1 Identifiant du produit : Bromure hexacyclodécane Formule chimique Enregistrement REACH N° : C 12 H 18 Br 6 01-2119539454-36-0005 Poids moléculaire 641.5 Famille chimique Cycloalcane halogéné 1.2. Usages identifiés pertinents Ingnifuge de la substance ou du mélange et usages déconseillés 1.3. Détails du fournisseur de la ICL-IP Terneuzen B.V. P.O. Box 318, 4530 AH Terneuzen, Pays-Bas fiche de données de sécurité Tél. (00 31) 115 689000 e-mail:[email protected] Téléphone en cas d'urgence : - Pour l'Europe - Pour le Royaume-Uni et l'Irlande ( +31) 115 689000 +44 (0) 1270 502891 (24 Hours) Section 2 : IDENTIFICATION DES DANGERS 2.1. Classification de la substance ou du mélange Classification selon la Réglementation (CE) N° 1272/2008 [CLP/GHS] Informations supplémentaires Lact. H362 Peut être nocif pour les bébés nourris au lait maternel. Aquatique aigu 1, H400: Très toxique pour les organismes aquatiques Aquatique chronique 1, H410 Très toxique pour les organismes aquatiques, entraîne des effets néfastes à long terme Aucun(e) Classification selon la Directive R64: Puede perjudicar a los niños alimentados con leche materna. 67/548/CEE, 1999/45/EC Dangereux pour l'environnement ; R50/53:Très toxique pour les organismesaquatiques, peut entraîner des effets néfastes à long terme pour l'environnementaquatique Page 1 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ 2.2. Eléments d'étiquette Étiquetage conformément à la Réglementation CLP CE (N°) 1272/2008 Mention d'avertissement ATTENTION Mentions de danger H361 - Susceptible de nuire à la fertilité ou au foetus H362 - Peut être nocif pour les bébés nourris au lait maternel H410 - Très toxique pour les organismes aquatiques, entraîne des effets néfastes à long terme Conseils de prudence sécurité P260 - Ne pas respirer les poussières/fumées/gaz/brouillards/vapeurs/aérosols P263 - Éviter tout contact avec la substance au cours de la grossesse/pendant P391 - Recueillir le produit répandu P280 - Porter des gants de protection/des vêtements de protection/un équipement de protection des yeux/du visage chimiques conformément aux législations locales, régionales, nationales et internationales 2.3. Autres dangers Hexabromocyclododecane est une substance persistante, bioaccumulative et toxique (PBT) conformément aux critères de l'Annexe XIII de la réglementation REACH Page 2 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ 3. Composition / informations sur les composants Composants % en poids Index no. : Numéro EEC Hexabromocyclododécane 3194-55-6 99.5 602-109-00-4 221-695-9 Classification de l'UE Repr. 2 H361 Lact. H362 Aquatic Acute 1, H400 Aquatic Chronic 1, H410 (In accordance with CLP 1272/2008) Repr.Cat. 3;R63 R64 N;R50/53 (In accordance with DSD 67/548/EEC) 4. Premier Secours 4.1. Description des premiers soins Contact oculaire En maintenant les paupières ouvertes, immédiatement rincer abondammment avec de l'eau courante pendant 20 minutes au moins. Consulter immédiatement un médecin. Contact cutané Retirer tous vêtements contaminés. Rincer la peau soigneusement avec du savon doux et de l'eau en abondance durant 15 minutes au moins. Nettoyer les vêtements avant de les réutiliser. Consulter immédiatement un médecin. Inhalation En cas d'inhalation de poussières ou de vapeur provenant des matériaux chauffés, transporter la victime à l'air libre. Veiller à ce que la victime reste calme et n'ait pas froid. Pratiquer la respiration artificielle si nécessaire et consulter un médecin immédiatement. Ingestion En cas d'ingestion, laver soigneusement la bouche avec une grande quantité d'eau. Consulter immédiatement un médecin. ------------------------------------------------------------------------------------IMPORTANT : Ne jamais faire boire une personne inconsciente -------------------------------------------------------------------------------------Page 3 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ 4.2. Symptômes et effets les plus importants, à la fois immédiatement et ultérieurement 4.3. Indication de consultation Traiter en fonction des symptômes et des besoins. immédiate d'un médecin et de Pas d'antidote spécifique. traitement particulier nécessaire 5. Lutte contre l'Incendie 5.1. Supports d'extinction Ce produit n'est pas inflammable. Adapter les moyens d'extinction aux conditions d'incendie environnantes. La poussière n'est pas sensible à l'allumage à partir de décharges statiques. La 5.2 Dangers particuliers découlant de la substance ou du poussière risque de former avec l'air un mélange faiblement explosif (Catégorie mélange de HBr. 5.3. Conseils pour les pompiers Refroidir les conteneurs en vaporisant de l'eau. Dans les entrepôts fermés, fournir un appareil respiratoire autonome aux pompiers en mode de pression positive. 6. Mesures en cas de dispersion accidentelle 6.1. Précautions personnelles, équipements de protection et procédures d'urgence Porter un appareil de protection respiratoire, des lunettes de protection chimiques, des gants et des bottes en caoutchouc. 6.2. Précautions environnementales Empêcher les émissions du produit dans l'environnement, y compris l'air, les sols et tous les cours d'eau. 6.3. Méthodes et matériaux pour Ramasser à la pelle dans des emballages intacts et les jeter comme déchets dangereux ou en vue d'une éventuelle réutilisation. Eviter de soulever de la contenir et nettoyer poussière. Aérer la zone et laver le site du déversement après ramassage complet des matériaux. 6.4 Renvoi à d'autres sections Aucune. Page 4 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ 7. Manipulation et Stockage 7.1. Précautions à prendre pour Eviter tout contact avec le corps. Veiller à ce que les conteneurs soient une manipulation sans danger hermétiquement fermés. 7.2. Conditions de stockage en Entreposer dans un lieu sec et bien aéré à l'écart des matières incompatibles (cf. section 10). toute sécurité, y compris les incompatibilités 7.3. Usage final spécifique Pas d'exigences spécifiques 8. Contrôle d'exposition/Protection individuelle 8.1. Paramètres de contrôle Composants % en poids Données ACGIH - TLV Hexabromocyclododécane 3194-55-6 99.5 Non déterminé Recommandation du fabricant DONNÉES SELON RU EH40 MEL (TABLE 1) TWA Non déterminé Valeurs limite du TRGS data Non déterminé TWA- 1 mg/m³ Les DNEL (Niveaux sans effets dérivés) et PNEC (Concentrations sans effets prédits) pour les voies et les compartiments sujets d'inquiétude sont présentés ci-dessous : DNELS pour les travailleurs Effets systémiques à long terme 2040 mg/kg bw/jour (dermique) 1.43 mg/m³ (inhalation) DNEL pour la population générale Effets systémiques à long terme 1020 mg/kg bw/jour (dermique) 0.719 mg/m³ (inhalation) 0.719 mg/kg bw/jour (oral) PNEC eau 0.31 µg/l (eau potable) 0.062 µg/l (eau de mer) PNEC sédiments 10 mg/kg sédiments dw (eau potable) 1 mg/kg sédiment dw (eau de mer) Page 5 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ PNEC sol 12.8 mg/kg sol dw PNEC centrale d'épuration des eaux (STP) 0.15 mg/l 8.2. Contrôles d'exposition Exigences d'aération Equipements de protection individuelle : - Protection respiratoire La ventilation doit suffire à maintenir une concentration atmosphérique au-Dessous de la limite d'exposition recommandée. Casque respiratoire homologué - Protection des mains - Protection des yeux - Protection de la peau et du corps Gants de protection chimique Lunettes de protection chimique Combinaison et bottes Mesures d'hygiène Ne pas manger, fumer ou boire pendant la manipulation, le traitement ou le stockage du produit. Se laver les mains completement apres toute manipulation et avant de manger ou de fumer. Une douche de sécurité et un bain oculaire doivent être fournis. 9. Propriétés physiques et chimiques 9.1. Informations sur les propriétés physiques et chimiques de base Aspect Point/intervalle de fonte Point/intervalle d'ébullition Point d'éclair Taux d'évaporation (éther=1) Pression de vapeur Densité de vapeur Solubilité : - Solubilité dans l'eau - Solubilité dans d'autres solvants Coefficient de répartition octanol/eau Température d'autoignition Dangers d'explosion Poudre cristalline de couleur blanc à blanc cassé s'écoulant librement 175-185°C Non applicable (se décompose) Sans objet Non applicable aux conditions standards 6.45 x 10(-5) Pa (21°C) Non applicable aux conditions standards 66 µg/l (20°C) Styrène : 10 g/100g à 25°C Acétone : 7g/100g à 25°C Toluène : 6,5 g/100g à 25°C Puissance enregistrée - 5.625 (25°C) Sans objet Pas explosif Page 6 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ Propriétés comburantes Température de décomposition Limites d'explosion/d'inflammation Gravité spécifique Pas d'oxydation > 230°C Non inflammable 2.18 10. Stabilité et Réactivité 10.1 Réactivité Aucun à notre connaissance. 10.2 Stabilité chimique Stable sous conditions normales. 10.4 Conditions à éviter Chauffage au-dessus de 230 °C 10.5 Matières incompatibles Agents oxydants 10.6 Produits de décomposition HBr dangereux 11. Informations toxicologiques 11.1 Informations sur les effets toxicologiques Toxicité aiguë : - Rat, oral DL50 >5,000 mg/kg - Lapin, cutané DL50 >8,000 mg/kg - Rat, inhalation CL50 >200 mg/l/1 hour Grave détérioration/irritation des Non irritant yeux Corrosion/irritation de la peau Non irritant Sensibilisation des voies respiratoires ou de la peau N'est pas un agent sensibilisant Mutagénicité Non mutagène selon le test d'Ames Non clastogène au cours des tests réalisés sur les aberrations chromosomiques des lymphocytes humains Cancérogénicité Non classé par l'IARC. Pas inclus dans le Rapport des produits cancérigènes NTP 12 Page 7 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ Teratogénèse Non tératogène, NOAEL=1000 mg/kg poids du corps (rat, gavage) NOAEL 300 mg/kg/jour (4 semaines, oral, rat). NOAEL 1000 mg/kg/jour (13 Toxicité d'organes cibles spécifiques (STOT) - exposition semaines, oral, rat). répétée 12. Informations écologiques 12.1 Toxicité Toxicité aquatique : - 96 heures-LC50 - Poisson >6.8 ug/L, nominal, (Rainbow trout) 72 heures - EC50 -- Algue marine52 ug/l (Skeletonema costatum) >6.8 ug/L, 96 Hours, nominal (Selenastrum capricornutum) - EC50, Algues d'eau douce 12.2 Persistance et dégradabilité Biodégradable inhérente Dans des sédiments, HBCD n'est pas persistant dans des conditions aérobies ou anaérobies avec des valeurs de demi-vie de 11 à 32 jours et de 1,1 à 1,5 jours, respectivement. Dans le sol, HBCD n'est pas persistant dans des conditions anaérobies mais est persistant dans des conditions aérobies avec des valeurs de demi-vie de 6,9 jours et 64 à 441 jours, respectivement. 12.3 Potentiel bioaccumulatif HBCD est considéré comme bioaccumulatif. Une valeur BCF d'état constant de 8,974 a été obtenue dans un test de bioconcentration à flux traversant avec la truite arc-en-ciel. 12.4 Mobilité dans le sol L'adsorption/désorption de la substance a été démontrée comme étant élevée (log Koc >5) En raison de la solubilité dans l'eau et du coefficient d'adsorption/désorption de HBCD, la distribution dans les sols n'est anticipée qu'à partir de particules en suspension et au cours d'événements d'inondations. 12.5 Résultats d'évaluation PBT Critères PBT remplis et vPvB 12.6 Autres effets négatifs Aucun à notre connaissance Page 8 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ 13. Considerations relatives a l'elimination 13.1 Méthodes de traitement des déchets Traiter les déchets solides et les déchets d'emballage dans un incinérateur équipé Elimination des déchets d'un système adéquat de nettoyage de gaz ou les envoyer à une décharge contrôlée. Eliminer soigneusement conformément aux réglementations locales/nationales. 14. Informations relatives au transport Numéro ONU 3077 ADR/RID Appellation réglementaire d'expédition : Substance dangereuse pour l'environnement, solide, sans autres précisions (Bromure hexacyclodécane) Catégorie : 9 - Substances et articles dangereux divers Modèle d'étiquette de signalisation de danger n° : 9 Identification de risque N° 90 Groupe d'emballage : III Code de classification : M74 Marquage : Substance dangereuse pour l'environnement IMO Appellation réglementaire d'expédition : Substance dangereuse pour l'environnement, solide, sans autres précisions (Bromure hexacyclodécane) Catégorie : 9 - Substances et articles dangereux divers. Etiquette : 9 Groupe d'emballage : III Marquage : POLLUANT MARIN ICAO/IATA Appellation réglementaire d'expédition : Substance dangereuse pour l'environnement, solide, sans autres précisions (Bromure hexacyclodécane) Catégorie : 9 Etiquette(s) de risque : Divers Groupe d'emballage : III Marquage : Substance dangereuse pour l'environnement Page 9 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ 15. Informations réglementaires 15.1 Réglementations et législations de sécurité, de santé et de protection de l'environnement pour la substance ou le mélange UE HBCDD a été ajouté à ANNEXE XIV, Substances soumises à autorisation, selon Administratif norvégien Répertorié dans la liste d'observation des produits chimiques 2002 Substance prioritaire pour la réduction des émissions d'ici 2010. Etats-Unis Répertorié dans l'inventaire EPA TSCA Australie Répertorié dans AICS Canada Répertorié dans DSL Inventaire de Chine Répertorié Japon ENCS n° 3-2254 ISHL n° 3-2254 Type III Contrôle des substances chimiques. Corée Répertorié dans l'ECL (KE-18398) Nouvelle-Zélande Répertorié dans NZIoC Philippines Répertorié dans PICCS 15.2 Évaluation de sécurité chimique Une évaluation de sécurité chimique a été effectuée conformément à la réglementation REACH. Scénario d'exposition disponible. 16. Information complémentaire Cette fiche de données de sécurité comporte des modifications par rapport à la version précédente dans la (les) section(s) 8 Page 10 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ Politique de protection de la santé, de la sécurité et de l'environnement Nous nous efforçons de nous assurer que nos opérations et nos produits répondent aux besoins de la communauté internationale actuelle sans compromettre la capacité des générations futures à répondre à leurs besoins Nous reconnaissons que le succès de notre entreprise dépend de la fourniture de produits et de services qui bénéficient à la société tout en assurant la sécurité des êtres humains et la protection de l'environnement et des ressources naturelles Dans le cadre de notre engagement en faveur du programme de responsabilité d'entreprise, nous fournissons un environnement de travail protégeant la sécurité et la santé des employés et nous gérons en toute responsabilité nos produits à tous les niveaux de leur cycle de vie pour protéger la santé des êtres humains et l'environnement tout en maintenant des normes élevées de production et d'exploitation POUR TENIR CET ENGAGEMENT NOUS : Nous respecterons ou irons au-delà des exigences réglementaires nationales et internationales en vigueur et des autres exigences auxquelles nous adhérons communiquerons ouvertement et encouragerons activement le dialogue avec les employés, les clients et la communauté en ce qui promeuvent l'éthique de la responsabilité d'entreprise développerons et fournirons des produits qui peuvent être fabriqués, transportés, utilisés et éliminés en toute sécurité tout en répondant au mieux aux besoins de nos clients évalurons régulièrement, améliorerons continuellement et gérerons de manière responsable les risques de santé, de sécurité et d'environnement associés aux produits et aux processus à travers leur cycle de vie partagerons nos connaissances et notre expertise avec autrui et chercherons à apprendre et à incorporer des pratiques améliorées dans nos propres opérations éduquerons et formerons nos employés, nos sous-traitants et nos clients pour améliorer leurs performances en matière de protection de la santé, de la sécurité et de l'environnement (HSE) communiquerons des informations à jour pour permettre à nos employés, nos clients et aux autres parties intéressées de manipuler nos produits d'une manière responsable sur le plan environnemental et en toute sécurité ferons tout ce qui est en notre pouvoir pour travailler avec les clients, les fournisseurs, les distributeurs et les sous-traitants pour favoriser l'utilisation, le transport et l'élimination de nos produits chimiques en toute sécurité Programmes de responsabilité sociale de l'entreprise en matière de support de produits en coopération avec les clients, les distributeurs et les transporteurs Bien que les informations et les recommandations stipulées dans les présentes (ci-Après désignées les « informations ») soient présentées de bonne foi et considérées comme étant correctes à la date des présentes, ICL-IP Terneuzen BV ne prend aucun engagement en ce qui concerne l'exhaustivité ou l'exactitude desdites informations. Les informations sont fournies à la condition que les personnes les recevant feront usage de leurs propres déterminations quand à la sûreté et quand à l`aptitude à leur propres objectifs, avant usage. ICL-IP Terneuzen BV décline toute responsabilité quant à tout dommage découlant de la confiance en ces renseignements et de leur utilisation. AUCUNE ASSERTION NI GARANTIE, EXPRESSE OÙ TACITE, DE QUALITÉ MARCHANDE, DE CONVENANCE UN USAGE PARTICULIER, OÙ DE TOUTE AUTRE NATURE, NE SONT FAITES PAR LES PRÉSENTES QUANT AUX RENSEIGNEMENTS ET AU PRODUIT S`Y RAPPORTANT. En cas de différence entre le contenu de cette MSDS et sa version anglaise, la version anglaise prévaut. Page 11 sur 12 FICHE DE DONNEES DE SECURITE Conformément à la réglementation (UE) N° 1907/2006, Annexe II _____________________________________________________________________________________________ Nom du produit FR-1206 8303 Id produit 17/03/2014 Date de révision Révision 13 30/10/2012 Remplace _____________________________________________________________________________________________ Préparé par Division HERA en ISRAEL tel. : +/972-8-6297835 telefax : +/972-8-6297832 www.icl-Ip.com e-mail:[email protected] Fin de la Fiche de Données de Sécurité Page 12 sur 12 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Annex Index 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Introduction Overview of uses that were identified and assessed ES2a – Manufacture of Expanded Polystyrene (EPS) and EPS articles ES2b – Use of Expanded Polystyrene (EPS) articles ES3a - Manufacture of Extruded polystyrene (XPS) and XPS articles ES3b - Use of Extruded Polystyrene (XPS) articles ES4a – Manufacture of high impact polystyrene (HIPS) and masterbatch and manufacture of HIPS articles ES4b – Use of high impact polystyrene (HIPS) articles ES5a – Manufacture of polymer dispersion for textiles and textile articles ES5b – Use of textile articles containing polymer dispersion ES6a – Manufacture of flexible elastomeric foam (FEF) and FEF articles ES6b – Use of flexible eslatomeric foam (FEF) articles ES7 - Additional formulation use (no further information available) Introduction According to REACH Art. 37(5) downstream users of chemical substances shall identify, apply and where suitable, recommend, appropriate measures to adequately control risks identified in the safety data sheet supplied to them. This identification and application of the appropriate measures is often called a compliance check. In this Annex to the SDS we have gathered all relevant exposure scenarios for the substance hexabromocyclododecane (HBCDD). In order for you to perform your compliance check an overview table is given below (Table 1) of all uses of HBCDD that were identified and for which an exposure scenario was generated. After you have localised your use in the table, you should check your compliance with the conditions described in the corresponding exposure scenario further down in this document. All assessments were carried out using the modeling tools ECETOC TRA (for human exposure) and EUSES (for environmental exposure). For human health, should you not be able to demonstrate compliance with the conditions described in the exposure scnearios below, there is an option to perform scaling running ECETOC TRA with your own data. Since scaling is not allowed with EUSES for environmental health1, your options in case of non-compliance are either to contact your supplier or to prepare your own Downstream User Chemical Safety Report. 1 The complexity of the EUSES model is of such a nature that it cannot be guaranteed that the Downstream User has used the exact same parameter values as the registrant (besides the plant-specific data he has input), allowing a correct scaling to be performed. Version 04-03-2013 1 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Table 1. Overview of uses that were identified and assessed Resulting life cycle stage ES2a – Manufacture of Expanded Polystyrene (EPS) and EPS articles x ES6a – Manufacture of flexible elastomeric foam (FEF) and FEF articles x x x x x x AC* x SU 3 SU 12 SU18 PC 32 AC 13 x SU 19 SU 21 SU 22 SU 23 SU 12 n/a PROC 3 PROC4 PROC 5 PROC 8b PROC 9 PROC 14 PROC 21 PROC 21 AC 3 AC 13 SU 19 SU 21 SU 22 SU 23 SU 10 SU12 SU 16 n/a PROC 5 PROC 12 PROC 14 PROC 21 AC 3 x SU 19 n/a PROC 3 PROC4 PROC 5 PROC 8b PROC 9 PROC 14 PROC 21 x SU 5 SU10 SU 18 PC 32 PC 34 AC 5 x SU 21 SU 22 n/a PROC 5 PROC 10 PROC 13 PROC 19 PROC 19 x SU 10 SU11 PC 32 AC 10 x SU 19 PC 32 PROC 2 PROC 3 PROC4 PROC 10 PROC 14 PROC 21 x SU 3 SU 10 PC 19 Waste stage PROC* x x PC 32 PC 0 (B450 0) PC 32 PROC 2 PROC 6 PROC 8a PROC 8b PROC 9 PROC 10 PROC 24c *SU = Sector of use; PC = Product Category; PROC = Process Category; AC = Article Category Version 04-03-2013 x PC* x x ES6b – Use of flexible eslatomeric foam (FEF) articles ES7 - Additional formulation use (no further information available) x x ES5b – Use of textile articles containing polymer dispersion SU* x x ES4b – Use of high impact polystyrene (HIPS) articles ES5a – Manufacture of polymer dispersion for textiles and textile articles x x ES3b - Use of Extruded Polystyrene (XPS) articles ES4a – Manufacture of high impact polystyrene (HIPS) and masterbatch and manufacture of HIPS articles Consumer use x ES2b – Use of Expanded Polystyrene (EPS) articles ES3a - Manufacture of Extruded polystyrene (XPS) and XPS articles End use Formulation ES number Service life (for articles) Identified uses AC 13 AC 3 AC 13 AC 3 AC 5 AC 10 AC 13 2 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 2a: Manufacture of Expanded Polystyrene (EPS) and EPS articles. The flame retardant, expanded polystyrene (EPS) is manufactured by mixing the registered substance (HBCDD) with styrene at low temperatures before charging into a reactor and polymerising at reaction temperature. HBCDD is trapped within the polymer matrix during polymerisation. An expansion agent is added to the reactor during the reaction and is absorbed by the polymer droplets (or beads). Manufacture of EPS beads takes place within a closed system with little potential for exposure. EPS beads can be used on-site to manufacture EPS articles, or can be stored, bagged/packaged and shipped to an EPS article manufacturer. Two different life cycle stages are distinguished in the Exposure Scenario: Manufacture of the expanded polystyrene and manufacture of expanded polystyrene articles. 2a.1. Exposure Scenario: Manufacture of Expanded Polystyrene (EPS) and EPS articles. Title Manufacture of Expanded Polystyrene (EPS) and EPS articles. Sector of use SU 3, 12, 18 Process category Manufacture of EPS: PROC 3, 4 Manufacture of EPS articles: 5, 8b, 9, 14, 21 Product category PC 32 Article category AC 13 Environmental release category Manufacture of Expanded Polystyrene (EPS) -‐ ERC 2, 3 Manufacture of EPS Articles – ERC 5 Specific environmental release category Not available Processes, tasks, activities covered All activities involved in manufacturing EPS and EPS articles. 2a.2. Operational conditions and risk management measures 2a.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)2 Annual site use: 188.88 tonnes, both for manufacturing EPS and EPS articles. Based upon a total annual EU tonnage for this use of 3400 tonnes, 18 use sites and 300 use days per annum Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data Environmental release data are available, indicating that release of HBCDD to the environment through manufacture of EPS beads and EPS articles will be very low Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 2 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 3 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor Emission factor water Manufacture of EPS: 0.02 (ERC 2) Manufacture of EPS articles: 0.5 (ERC 5) Emission factor air Manufacture of EPS: 0.30 (ERC 3) Manufacture of EPS articles: 0.5 (ERC 5) Emission factor soil Manufacture of EPS: 0.001 (ERC3) Manufacture of EPS articles: 0.01 (ERC 5) Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil EPS manufacture: All manufacturing facilities use an on-‐site STP to clean up waste-‐water. Releases via dust to air must be reduced, by filtering exhaust gases. Manufacture of EPS articles: The main release to soil is through disposal of contaminated packaging to landfill. This release can be reduced or eliminated by sending contaminated packaging to incineration. Emissions to air are minimal, however can be regulated by scrubbing and filtering emission gases (not required) Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal EPS manufacture: Waste water (daily emission: 4.4g/day for both manufacture of EPS and manufacture of EPS articles) can be treated by on-site or municipal STP. The registered substance is not harmful to sewage micro-organisms and is rapidly degraded in anaerobic conditions. Solid waste such as contaminated packaging is expected to be sent to incineration. Manufacture of EPS articles: A STP connection rate of 80% is assumed for the total, regional and continental release estimation. Conditions and measures related to external recovery of waste Not available, recovery of the registered substance from aqueous and solid wastes is not commercially feasible at the present time due to the low concentration of the registered substance in waste streams. 2a.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: HBCDD TRA dustiness: particle size distribution: 99% < 280µm Physical property: solid Amounts used Covers percentage substance in the product up to: EPS manufacture: Substance used as supplied in powder or granule form (i.e. 100%) Manufacture of EPS articles: 0.7 % Frequency and duration of use/exposure Covers daily exposures up to 8 hours (both scenarios) Other given operational conditions affecting workers exposure Indoor use, both uses Technical conditions and measures at process level (source) to prevent release EPS manufacture: Substance is loaded into an intermediate storage bin then drawn into a closed formulation process. Water used for preparation of EPS beads is reused in order to conserve the substance, which maybe present and reduce the amount released to the environment. Exposure during tabletting/compression/ extrusion/pellettisation is unlikely due to the low volatility of the substance and Version 04-03-2013 4 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 the closed nature of the processes. Any exposure would be negligible during low-energy manipulation of the polymer article as the substance will be held within the polymer matrix under normal working conditions. Manufacture of EPS articles: Processing takes place in a closed system; although the preparation is heated, the substance is unlikely to be released to air due to the low vapour pressure of the substance. Technical conditions and measures to control dispersion from source towards the worker EPS manufacture: Indoors with Local Exhaust Ventilation 90% efficiency (default ecetoc TRA) Manufacture of EPS articles: Indoors with Local Exhaust Ventilation 90% efficiency (default ecetoc TRA) Conditions and measures related to personal protection, hygiene and health evaluation EPS manufacture: Respiratory protection (90% effectiveness), used continuously wherever exposure is possible. Manufacture of EPS articles: Respiratory protection (90% effectiveness), used continuously wherever exposure is possible. Additional good practice advice beyond REACH Chemical Safety Assessment Not available 2a.3. Exposure estimation and reference to its source 2a.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance Solid Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment (calculated with ECETOC TRA) Value unit Local total daily intake for humans, total 7.21E-‐01 [mg.kg-‐1.day-‐1] Local PECs Unit AIR Annual average local PEC in air (total) 8.62E-‐07 [mg.m-‐3] WATER, SEDIMENT Local PEC in surface water during emission episode (dissolved) 4.26E-‐05 [mg.l-‐1] Annual average local PEC in surface water (dissolved) 3.51E-‐05 [mg.l-‐1] Local PEC in fresh-‐water sediment during emission episode 4.21E-‐02 [mg.kgwwt-‐1] Local PEC in seawater during emission episode (dissolved) 2.06E-‐05 [mg.l-‐1] Annual average local PEC in seawater (dissolved) 1.69E-‐05 [mg.l-‐1] Local PEC in marine sediment during emission episode 2.03E-‐02 [mg.kgwwt-‐1] SOIL, GROUNDWATER Local PEC in agric. soil (total) averaged over 30 days 6.39E-‐02 [mg.kgwwt-‐1] Local PEC in agric. soil (total) averaged over 180 days 6.39E-‐02 [mg.kgwwt-‐1] Local PEC in grassland (total) averaged over 180 days 2.52E-‐02 [mg.kgwwt-‐1] Local PEC in groundwater under agricultural soil 7.98E-‐05 [mg.l-‐1] STP PEC for micro-‐organisms in the STP 2.50E-‐01 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 2a.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation Version 04-03-2013 ECETOC TRA v2 5 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 General parameter set Type of setting: Industrial Duration of exposure: > 4hr/day Use of ventilation: Local Exhaust Ventilation 90% efficiency (default ECETOC TRA) Use of respiratory protection: Respiratory protection (90% effectiveness), used continuously wherever possible Use of dermal protection: none Concentration in preparation: > 25% (manufacture of EPS); 0.7% (manufacture of EPS articles) Exposure Estimations PROC 3 4 5 8b 9 14 21 Contributing scenarios 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 dedicated facilities Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Production of preparations or articles by tabletting, compression, extrusion, palletisation Low energy manipulation of substances bound in materials and/or articles Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs, in addition to those mentioned in 2a.2.2. 1.00E-‐02 3.43E-‐02 2.50E-‐02 6.86E-‐01 2.50E-‐01 6.86E-‐02 LEV Respiratory protection (90%) LEV Respiratory protection (90%) LEV Respiratory protection (90%) 1.25E-‐01 6.86E-‐01 LEV Respiratory protection (90%) 2.00E-‐01 6.86E-‐01 1.00E-‐01 3.43E-‐01 1.00E-‐01 2.83E-‐01 LEV Respiratory protection (90%) LEV Respiratory protection (90%) LEV Respiratory protection (90%) 2a.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 2a.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in manufacturing of Expanded Polystyrene (EPS) and EPS articles. 2a.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 6 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 2b: Use of Expanded Polystyrene (EPS) articles. 2b.1. Exposure Scenario: Use of Expanded Polystyrene (EPS) articles. Title Use of Expanded Polystyrene (EPS) articles. Sector of use SU 19, 21, 22, 23 Process category PROC 21 Product category Not available Article category AC 13 Environmental release category ERC 11a, 12a Specific environmental release category Emission factor to air: 3.5E-‐07 Emission factor to soil: 1E-‐04 Emission factors are based on the EU Risk Assessment. Processes, tasks, activities covered All activities involved in the use of expanded Polystyrene (EPS) articles. 2b.2. Operational conditions and risk management measures 2b.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)3 A worst case value of 1 tonne of EPS insulation board is estimated for a single site. The worst case value for the HBCDD concentration in EPS is 0.7% (w/w), therefore a worst case annual use amount per site is 7 kg. Due to the highly disperse use of the compound the environmental assessment was carried out on a regional scale. Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data Not available Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 2,000 Indoor/outdoor use of the substance Indoor and outdoor use Emission Factor Water Not applicable Emission Factor Air 3.5E-07 Emission Factor Soil 1E-04 Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil Not available 3 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 7 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Conditions and measures related to waste water treatment Size of STP (m3/day) 18,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal at the end of service life 100% of the EPS insulation board is discarded at the end of the life cycle (~20-50 years). 30-50% of the EPS in insulation boards is expected to be recycled while 50-70% is expected to go to landfill. An unknown amount of EPS insulation board is incinerated, either in unregulated burning (example: bonfires at households or at construction/demolition sites). Conditions and measures related to external recovery of waste Approximately 30-50% of the EPS insulation board is expected to be recycled. No labelling for recovered EPS material is currently available. Polymer waste streams are expected to be contaminated with HBCDD in low concentrations. 2b.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: hexabromocyclododecane TRA dustiness: low Physical property: solid (encapsulated in articles) Amounts used Covers percentage substance in the product up to 0.7 % Frequency and duration of use/exposure Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Indoor and outdoor use Technical conditions and measures at process level (source) to prevent release during service life The substance is bound within the polymer matrix reducing the amount of substance released to the environment. Conditions and measures at level of article production to prevent release during service life EPS insulation boards are ‘cured’ for approximately 1 week prior to supply for use. The HBCDD contained within the EPS insulation board is bound within the polymer matrix and is not expected to be bio-available. The EPS beads make the EPS insulation board friable during sawing and abrasive cutting, particles produced are not expected to be of an inhalable size. Any amount of the registered substance within the particles created would be held within the polymer matrix of the particles and would not be available for exposure. Human factors not influenced by risk management Exposure to the registered substance is negligible during installation of EPS articles as the substance will be held within the polymer matrix. Any residual or settled amount of the registered substance on the surface of the EPS article or any release during cutting of the EPS article is expected to be negligible as the substance is present at a maximum concentration of 0.7 % in the EPS beads. Conditions and measures related to personal protection, hygiene and health evaluation Not available Due to the size and weight of the EPS particulates formed during cutting and installation of the EPS board (>10μm) dermal exposure is considered to be the only significant route of exposure from particulates. Additional good practice advice beyond REACH Chemical Safety Assessment Sweep up any particles/beads of EPS created during cutting and dispose of to incineration or landfill. 2b.3. Exposure estimation and reference to its source 2b.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance Solid (encapsulated in articles) Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment (ECETOC TRA) Value Unit total daily intake for humans, total 2.39E-‐4 [mg.kg-‐1.day-‐1] Regional PECs Unit AIR Version 04-03-2013 8 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Annual average PEC in air (total) 2.17E-‐11 [mg.m-‐3] WATER, SEDIMENT PEC in surface water during emission episode (dissolved) 1.91E-‐09 [mg.l-‐1] PEC in fresh-‐water sediment during emission episode 3.44E-‐06 [mg.kgwwt-‐1] PEC in seawater during emission episode (dissolved) 2.02E-‐10 [mg.l-‐1] PEC in marine sediment during emission episode 3.70E-‐07 [mg.kgwwt-‐1] SOIL, GROUNDWATER PEC in agric. soil (total) 2.48E-‐07 [mg.kgwwt-‐1] PEC in grassland (total) averaged over 180 days 2.59E-‐07 [mg.kgwwt-‐1] PEC in groundwater under agricultural soil n.a. [mg.l-‐1] STP PEC for micro-‐organisms in the STP (ECETOC TRA ERC 12a) 1690 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 2b.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial Dustiness: Low Duration of exposure: > 4hr/day Use of ventilation: no Use of respiratory protection: no Use of dermal protection: no Concentration in preparation: 0.7 % Exposure Estimations PROC 21 Contributing scenarios Low energy manipulation of substances bound in materials and/or articles Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs, in addition to those mentioned in section 2b.2.2. 3.00 2.83 None 2b.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 2b.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in Expanded Polystyrene (EPS) articles. 2b.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 9 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 3a: Manufacture of Extruded Polystyrene (XPS) and XPS articles. HBCDD in powder or granules is mixed into the polymer in a semi-closed or open system, foaming agents are added and the preparation extruded and cut into granules and packaged for shipping to article manufacturers. The manufacture of XPS articles involves the foaming of the polymer preparations in semi-closed or open systems, followed by extrusion, cutting and shaping of the resulting polymer foam to the desired shape. XPS articles (mainly in the form of boards) are packed onto pallets and cured for 1 week prior to shipping. This exposure scenario covers both the manufacturing of the extruded polystyrene and manufacturing the articles. 3a.1. Exposure Scenario: Manufacture of Extruded Polystyrene (XPS) and XPS articles. Title Manufacture of Extruded Polystyrene (XPS) and XPS articles. Sector of use SU 12 Process category Manufacture XPS: PROC 5,14 Manufacture XPS articles: PROC 12, 14 Product category PC 32 Article category AC 3, 13 Environmental release category Manufacturing XPS: ERC 2, 3 Manufacturing XPS articles: ERC 5 Specific environmental release category Not available Processes, tasks, activities covered All activities involved in manufacturing XPS and XPS articles. 3a.2. Operational conditions and risk management measures 3a.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)4 Annual use per site: 123.6 tonnes, based on a total annual EU tonnage use 1730 / number of use sites (14). Both for manufacturing XPS and manufacturing XPS articles Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data Not available Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor use of substance in partially open system (open during loading and extrusion). 4 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 10 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Emission Factor Water Manufacturing XPS: 0.02 (ERC 2) Manufacturing XPS articles: 0.50 (ERC 5) Emission Factor Air Manufacturing XPS: 0.30 (ERC 3) Manufacturing XPS articles: 0.50 (ERC 5) Emission Factor Soil Manufacturing XPS: 0.001 (ERC 3) Manufacturing XPS articles: 0.01 (ERC 5) Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil XPS manufacture: Not available Manufacture of XPS articles: Waste generated by the foaming and trimming processes is recycled back into the process. Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal A waste water must be directed to a municipal waste water treatment plant. Conditions and measures related to external recovery of waste Not available 3a.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: hexabromocyclododecane Physical property: solid Amounts used XPS manufacture: Covers percentage substance in the product up to 100 % Manufacture of XPS articles: Covers percentage substance in the product up to 40 % Frequency and duration of use/exposure Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Indoor use Technical conditions and measures at process level (source) to prevent release XPS manufacture: Bags or supersacks are loaded into hopper designed to minimise dust emissions. The substance is then drawn into a closed system for mixing with polystyrene and extruded. Manufacture of XPS articles: XPS containing HBCDD or mixed with HBCDD during the melting and mixing process is further mixed with foaming or blowing agents to form a foam which can be extruded and cut to its final shape. The XPS board is cured for approximately 1 week prior to shipping and use. Technical conditions and measures to control dispersion from source towards the worker XPS manufacture: Local Exhaust Ventilation 90% efficiency (default ECETOC TRA) Manufacture of XPS articles: Local Exhaust Ventilation 90% efficiency (default ECETOC TRA) Conditions and measures related to personal protection, hygiene and health evaluation XPS manufacture: Respiratory protection (90% effectiveness), used continuously wherever exposure is possible. Manufacture of XPS articles: Version 04-03-2013 11 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Respiratory protection (90% effectiveness), used continuously wherever exposure is possible. Additional good practice advice beyond REACH Chemical Safety Assessment Not available 3a.3. Exposure estimation and reference to its source 3a.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance Solid Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment Value unit Local total daily intake for humans, total 1.06E-‐04 [mg.kg-‐1.day-‐1] Local PECs Unit AIR Annual average local PEC in air (total) 5.65E-‐07 [mg.m-‐3] WATER, SEDIMENT Local PEC in surface water during emission episode (dissolved) 2.79E-‐05 [mg.l-‐1] Annual average local PEC in surface water (dissolved) 2.29E-‐05 [mg.l-‐1] Local PEC in fresh-‐water sediment during emission episode 2.75E-‐02 [mg.kgwwt-‐1] Local PEC in seawater during emission episode (dissolved) 1.35E-‐05 [mg.l-‐1] Annual average local PEC in seawater (dissolved) 1.11E-‐05 [mg.l-‐1] Local PEC in marine sediment during emission episode 1.33E-‐02 [mg.kgwwt-‐1] SOIL, GROUNDWATER Local PEC in agric. soil (total) averaged over 30 days 4.18E-‐02 [mg.kgwwt-‐1] Local PEC in agric. soil (total) averaged over 180 days 4.18E-‐02 [mg.kgwwt-‐1] Local PEC in grassland (total) averaged over 180 days 1.65E-‐02 [mg.kgwwt-‐1] Local PEC in groundwater under agricultural soil 5.22E-‐05 [mg.l-‐1] STP PEC for micro-‐organisms in the STP 2.98E-‐04 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial Duration of exposure: > 4hr/day Use of ventilation: Local Exhaust Ventilation 90% efficiency (default ECETOC TRA) Use of individual respiratory protection: Respiratory protection (90% effectiveness), used wherever exposure is possible Use of dermal protection: none Concentration in preparation: > 25% Exposure Estimations PROC 5 Contributing scenarios Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) Version 04-03-2013 Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs, in addition to those listed in section 3a.2.2. 5.00E-‐03 6.86E-‐02 LEV Respiratory protection 12 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 12 Use of blowing agents in manufacture of foam 14 Production of preparations or articles by tabletting, compression, extrusion, palletisation 3.21E-‐02 3.43E-‐02 1.00E-‐03 3.41E-‐01 LEV Respiratory protection LEV Respiratory protection 3a.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 3a.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in the manufacture of Extruded Polystyrene (XPS) and XPS articles. 3a.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 13 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 3b: Use of Extruded Polystyrene (XPS) articles. 3b.1. Exposure Scenario: Use of Extruded Polystyrene (XPS) articles. Title Use of Extruded Polystyrene (XPS) articles. Sector of use SU 19, 21, 22, 23 Process category PROC 21 Product category Not available Article category Not available Environmental release category ERC 11a, 12a Specific environmental release category Not available Processes, tasks, activities covered All activities involved in the use of Extruded Polystyrene (XPS) articles. 3b.2. Operational conditions and risk management measures 3b.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)5 A worst case value of 1 tonne of XPS is expected to be cut by workers per site per day (300 tonnes/year). The worst-‐case concentration of the registered substance in XPS is 3% therefore a worst-‐case daily site use of 30 kg/day (or 900 kg/year) is expected. Since the use is widely dispersive in nature, the environmental assessment is based on regional concentrations Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data Not available Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor and outdoor Emission Factor Water 0.025 Emission Factor Air 0.025 Emission Factor Soil 0.025 Risk Management Measures Technical measures at the production level to limit or reduce discharges during service life Many of the construction articles that are made of XPS do not require any trimming or cutting during installation, 5 This is the tonnage that is maximally allowed to be used by the Downsteam User on his site Version 04-03-2013 14 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 and so reduce overall waste and emissions to the environment. Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal A sewage treatment plant is considered to be in place Conditions and measures related to external recovery of waste Not available 3b.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: hexabromocyclododecane TRA dustiness: low Physical property: solid Amounts used Covers percentage substance in the product up to 3 % (realistic worst case) Frequency and duration of use/exposure Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Indoor and outdoor use Technical conditions and measures at article production level (source) to prevent release during service life The substance is bound within the polymer matrix and will not be released. The XPS boards are cured for approximately 1 week prior to shipping and use. Technical conditions and measures to control dispersion from source towards the worker Not available Conditions and measures related to personal protection, hygiene and health evaluation Not available Additional good practice advice beyond REACH Chemical Safety Assessment Not available 3b.3. Exposure estimation and reference to its source 3b.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance solid Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment Value unit Total daily intake for humans (ECETOC TRA) 1.22E-‐04 [mg.kg-‐1.day-‐1] Regional PECs Unit AIR Annual average PEC in air (total) 1.22E-‐12 [mg.m-‐3] WATER, SEDIMENT PEC in surface water during emission episode (dissolved) 1.36E-‐10 [mg.l-‐1] PEC in fresh-‐water sediment during emission episode 2.46E-‐07 [mg.kgwwt-‐1] PEC in seawater during emission episode (dissolved) 1.31E-‐11 [mg.l-‐1] PEC in marine sediment during emission episode 2.59E-‐08 [mg.kgwwt-‐1] SOIL, GROUNDWATER PEC in agric. soil (total) 1.39E-‐08 [mg.kgwwt-‐1] PEC in grassland (total) averaged over 180 days 1.46E-‐08 [mg.kgwwt-‐1] PEC in groundwater under agricultural soil n.a. [mg.l-‐1] Version 04-03-2013 15 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 STP PEC for micro-‐organisms in the STP (ECETOC TRA, ERC 11a) 859 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 3b.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial Dustiness: Low (exposure is to cut off waste, which high particle sizes) Duration of exposure: > 4hr/day Use of ventilation: no Use of respiratory protection: no Use of dermal protection: no Concentration in preparation: 3 % Exposure Estimations PROC 21 Contributing scenarios Low energy manipulation of substances bound in materials and/or articles Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs 3.00E-‐03 2.83E-‐03 none 3b.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 3b.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in Extruded Polystyrene (XPS) articles. 3b.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 16 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 4a: Manufacture of High Impact Polystyrene (HIPS) and masterbatch and manufacture of HIPS articles High Impact Polystyrene (HIPS) can be manufactured either by the mixing of HBCDD into the polystyrene at the desired formulation or in higher concentrations to create a “masterbatch” which can then be blended with ‘virgin’ polystyrene to create HIPS with the desired concentration of the registered substance. HIPS articles are manufactured by extrusion, moulding and/or cutting/shaping to form the desired shape. This exposure scenario covers both the actual manufacturing of HIPS and the manufacturing of HIPS articles. 4a.1. Exposure Scenario: Manufacture of High Impact Polystyrene (HIPS) and masterbatch and manufacture of HIPS articles Title Manufacture of High Impact Polystyrene (HIPS) and masterbatch and manufacture of HIPS articles Sector of use SU 10, 12, 16 Process category HIPS manufacture and masterbatch PROC 3, 4, 5, 8b, 9 Manufacture of HIPS articles PROC 5, 8b, 14 Product category PC 32 Article category AC 3 Environmental release category HIPS manufacture and masterbatch ERC 2, 3 Manufacture of HIPS articles ERC 5 Specific environmental release category Not available Processes, tasks, activities covered All activities involved in manufacturing High Impact Polystyrene (HIPS) and masterbatch and HIPS articles 4a.2. Operational conditions and risk management measures 4a.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)6 Annual use per site = 250 tonnes/year Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data 6 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 17 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Measured data for environmental exposure is available which shows that emissions from all uses of the registered substance across the entire EU area are very low (VECAP, 2010). Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor. Where applicable mixing of HIPS with masterbatch takes place in a closed system. Manufacture of HIPS articles takes place in closed systems. Emission Factor Water HIPS manufacture and masterbatch: 0.02 (ERC 2) Manufacture of HIPS articles: 0.50 (ERC 5) Emission Factor Air HIPS manufacture and masterbatch: 0.30 (ERC 3) Manufacture of HIPS articles: 0.50 (ERC 5) Emission Factor Soil HIPS manufacture and masterbatch: 0.001 (ERC 3) Manufacture of HIPS articles: 0.01 (ERC 5) Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil HIPS manufacture: An on-‐site STP is indicated by some users, if an on-‐site STP is not in use a municipal STP must be used. Releases via dust to air are reduced by filtering exhaust gases (Size and effectiveness of filter not determined). Manufacture of HIPS articles: HIPS articles are designed specifically not to be drilled, cut or otherwise modified. Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal Not available Conditions and measures related to external recovery of waste Not available 4a.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: hexabromocyclododecane Physical property: solid Amounts used Substance contained at ca. 7% (w/w) in HIPS and at higher yet unspecified concentrations in masterbatch. Frequency and duration of use/exposure Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Indoor use Technical conditions and measures at process level (source) to prevent release HIPS manufacture and masterbatch: Formulation of preparations and blending operations are expected to be carried out in semi-‐closed or open systems. Closed process for metering and compounding at high temperature. Manufacture of HIPS articles: Reformulation and manufacture (heating, mixing and moulding) takes place in closed systems. Technical conditions and measures to control dispersion from source towards the worker HIPS manufacture and masterbatch: Local Exhaust Ventilation (LEV) 90% efficiency (default ECETOC TRA) Version 04-03-2013 18 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Manufacture of HIPS articles: Local Exhaust Ventilation (LEV) 90% efficiency (default ECETOC TRA) Conditions and measures related to personal protection, hygiene and health evaluation HIPS manufacture and masterbatch: Respiratory protection (90% effectiveness), used continuously wherever exposure is possible. Manufacture of HIPS articles: Respiratory protection (90% effectiveness), used continuously wherever exposure is possible. Additional good practice advice beyond REACH Chemical Safety Assessment Not available 4a.3. Exposure estimation and reference to its source 4a.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance Solid Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment Value unit Local total daily intake for humans, total (ECETOC TRA) 6.10E-‐05 [mg.kg-‐1.day-‐1] Local PECs Unit AIR Annual average local PEC in air (total) 3.27E-‐07 [mg.m-‐3] WATER, SEDIMENT Local PEC in surface water during emission episode (dissolved) 1.65E-‐05 [mg.l-‐1] Annual average local PEC in surface water (dissolved) 1.35E-‐05 [mg.l-‐1] Local PEC in fresh-‐water sediment during emission episode 1.62E-‐02 [mg.kgwwt-‐1] Local PEC in seawater during emission episode (dissolved) 7.96E-‐06 [mg.l-‐1] Annual average local PEC in seawater (dissolved) 6.54E-‐06 [mg.l-‐1] Local PEC in marine sediment during emission episode 7.86E-‐03 [mg.kgwwt-‐1] SOIL, GROUNDWATER Local PEC in agric. soil (total) averaged over 30 days 2.47E-‐02 [mg.kgwwt-‐1] Local PEC in agric. soil (total) averaged over 180 days 2.47E-‐02 [mg.kgwwt-‐1] Local PEC in grassland (total) averaged over 180 days 9.74E-‐03 [mg.kgwwt-‐1] Local PEC in groundwater under agricultural soil 3.08E-‐05 [mg.l-‐1] STP PEC for micro-‐organisms in the STP 1.76E-‐04 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 4a.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial Duration of exposure: > 4hr/day Use of ventilation: Local Exhaust Ventilation (90% efficiency, default ECETOC TRA) Use of respiratory protection: Respiratory protection (90% effectiveness), used wherever exposure is possible Use of dermal protection: no Concentration in preparation: < 25% Version 04-03-2013 19 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Estimations PROC 3 4 5 8b 9 14 Contributing scenarios 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 dedicated facilities Transfer of substance or preparation into small containers (dedicated filling line, including weighing) Production of preparations or articles by tabletting, compression, extrusion, palletisation Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs, in addition to those listed in section 4a.2.2. 1.00E-‐02 3.43E-‐02 2.50E-‐01 6.86E-‐01 2.50E-‐01 6.86E-‐02 LEV Respiratory protection LEV Respiratory protection LEV Respiratory protection 1.25E-‐01 6.86E-‐01 LEV Respiratory protection 2.00E-‐01 6.86E-‐01 1.00E-‐01 3.43E-‐01 LEV Respiratory protection LEV Respiratory protection 4a.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 4a.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in manufacturing High Impact Polystyrene (HIPS) and masterbatch and manufacture of HIPS articles 4a.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 20 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 4b: Use of High Impact Polystyrene (HIPS) articles. 4b.1. Exposure Scenario: Use of High Impact Polystyrene (HIPS) articles. Title Use of High Impact Polystyrene (HIPS) articles. Sector of use SU 19 Process category PROC 21 Product category Not available Article category AC 3 Environmental release category ERC 11a, 12a Specific environmental release category Not available Processes, tasks, activities covered Use of High Impact Polystyrene (HIPS) articles. 4b.2. Operational conditions and risk management measures 4b.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)7 Annual tonnage 1000 tonnes/year is used as realistic worst-‐case value. The article is not expected to be processed at the site apart from assembly of moulded parts and installation. HIPS articles are expected to be small and contain HBCDD at a maximum concentration of 7%. As the use is wide dispersive the environmental assessment is based on a regional scale. Fraction of main local source 0.15 Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data Not available Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor use Emission Factor Water 0.025 Emission Factor Air 0.025 Emission Factor Soil 0.025 Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil 7 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 21 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Not available Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal All waste water must be directed to an STP Conditions and measures related to external recovery of waste Not available 4b.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: hexabromocyclododecane TRA dustiness: low Physical property: solid Amounts used Covers percentage substance in the product up to 7 % Frequency and duration of use/exposure Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Indoor use Technical measures at the article production level (source) to prevent release during service life HIPS articles are designed for use without, drilling, cutting or other modification. The substance is bound within the polymer matrix and is not released. No containment is necessary to limit exposure as the substance cannot be released from the polymer matrix under normal working conditions. Technical conditions and measures to control dispersion from source towards the worker No engineering controls required as there is no exposure from use of the article under normal working conditions. Conditions and measures related to personal protection, hygiene and health evaluation No personal protective equipment PPE required as there is no expected exposure from use of the article under normal working conditions. Additional good practice advice beyond REACH Chemical Safety Assessment Not available 4b.3. Exposure estimation and reference to its source 4b.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance Solid (encapsulated in articles) Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment Value unit Local total daily intake for humans, total (ECETOC TRA) 7.02E-‐05 [mg.kg-‐1.day-‐1] Regional PECs Unit AIR Annual average PEC in air (total) 2.5E-‐15 [mg.m-‐3] WATER, SEDIMENT PEC in surface water during emission episode (dissolved) 1.35E-‐14 [mg.l-‐1] PEC in fresh-‐water sediment during emission episode 2.63E-‐11 [mg.kgwwt-‐1] PEC in seawater during emission episode (dissolved) 3.49E-‐15 [mg.l-‐1] PEC in marine sediment during emission episode 6.62E-‐12 [mg.kgwwt-‐1] SOIL, GROUNDWATER PEC in agric. soil (total) 2.88E-‐11 [mg.kgwwt-‐1] Version 04-03-2013 22 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 PEC in grassland (total) averaged over 180 days 3.01E-‐11 [mg.kgwwt-‐1] PEC in groundwater under agricultural soil n.a. [mg.l-‐1] STP PEC for micro-‐organisms in the STP (ECETOC TRA, ERC 12a) 497 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 4b.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial Dustiness: Low Duration of exposure: > 4hr/day Use of ventilation: no Use of respiratory protection: no Use of dermal protection: no Concentration in preparation: < 25 % Exposure Estimations PROC 21 Contributing scenarios Low energy manipulation of substances bound in materials and/or articles Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs 3.00 2.83 No 4b.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 4b.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in High Impact Polystyrene (HIPS) articles. 4b.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 23 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 5a: Manufacture of Polymer dispersion for textiles and textile articles. The polymer based back coating is formulated in the polymer industry for supply to textiles and furniture manufacturers. HBCDD is formulated in an open batch system by mixing the fine powder of the registered substance into a dispersion of the polymer in water (commonly synthetic latex, acrylates or PVC) together with thickeners and dispersion agents. The polymer dispersion is then supplied to textile or furniture manufacturers for use as a back coating. This scenario covers both the manufacturing of polymer dispersion for textiles and the manufacturing of textile articles. 5a.1. Exposure Scenario: Manufacture of Polymer dispersion for textiles and textile articles. Title Manufacture of Polymer dispersion for textiles and textile articles. Sector of use SU 5, 10, 18 Process category Manufacture of polymer dispersion for textiles PROC 5 Manufacture of textile articles PROC 10, 13, 19 Product category PC 32, 34 Article category AC 5 Environmental release category Manufacture of polymer dispersion for textiles ERC 2 Manufacture of textile articles ERC 5 Specific environmental release category Not available Processes, tasks, activities covered All activities involved in the manufacturing of polymer dispersion for textiles and textile articles. 5a.2. Operational conditions and risk management measures 5a.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)8 65.6 tonnes/year Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data Not available Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 8 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 24 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor Emission Factor Water Manufacture of polymer dispersion for textiles, 0.02 (ERC 2) Manufacture of textile articles: 0.50 (ERC 5) Emission Factor Air Manufacture of polymer dispersion for textiles: 0.025 (ERC 2) Manufacture of textile articles: 0.50 (ERC 5) Emission Factor Soil Manufacture of polymer dispersion for textiles: 0.0001 (ERC 2) Manufacture of textile articles: 0.01 (ERC 5) Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil Manufacture of polymer dispersion for textiles Not available Manufacture of textiles Solid waste including sludge from on-‐site STPs at textile backcoaters is either incinerated or put on controlled landfills, due to the potential of heavy metal contamination. Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal Not available Conditions and measures related to external recovery of waste Not available 5a.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: Hexabromocyclododecane TRA dustiness: high Physical property: solid Amounts used Manufacture of polymer dispersion for textiles: Covers percentage substance in the product up to 100 % Manufacture of textile articles: Covers percentage substance in the product up to 25 % Frequency and duration of use/exposure Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Indoor use Technical conditions and measures at process level (source) to prevent release Not available Technical conditions and measures to control dispersion from source towards the worker Manufacture of polymer dispersion for textiles: Local Exhaust Ventilation (LEV), 90% efficiency (default ECETOC TRA) Manufacture of textile articles: Local Exhaust Ventilation (LEV), 90% efficiency (default ECETOC TRA) Conditions and measures related to personal protection, hygiene and health evaluation Manufacture of polymer dispersion for textiles: respiratory protection (90% effectiveness) Manufacture of textile articles: Version 04-03-2013 25 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 respiratory protection (90% effectiveness) Additional good practice advice beyond REACH Chemical Safety Assessment Not available 5a.3. Exposure estimation and reference to its source 5a.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance solid Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment Value unit Local total daily intake for humans, total (ECETOC TRA) 5.2E-‐05 [mg.kg-‐1.day-‐1] Local PECs Unit AIR Annual average local PEC in air (total) 3.02E-‐07 [mg.m-‐3] WATER, SEDIMENT Local PEC in surface water during emission episode (dissolved) 1.48E-‐05 [mg.l-‐1] Annual average local PEC in surface water (dissolved) 1.22E-‐05 [mg.l-‐1] Local PEC in fresh-‐water sediment during emission episode 1.46E-‐02 [mg.kgwwt-‐1] Local PEC in seawater during emission episode (dissolved) 7.16E-‐06 [mg.l-‐1] Annual average local PEC in seawater (dissolved) 5.89E-‐06 [mg.l-‐1] Local PEC in marine sediment during emission episode 7.07E-‐03 [mg.kgwwt-‐1] SOIL, GROUNDWATER Local PEC in agric. soil (total) averaged over 30 days 2.22E-‐02 [mg.kgwwt-‐1] Local PEC in agric. soil (total) averaged over 180 days 2.22E-‐02 [mg.kgwwt-‐1] Local PEC in grassland (total) averaged over 180 days 8.77E-‐03 [mg.kgwwt-‐1] Local PEC in groundwater under agricultural soil 2.77E-‐05 [mg.l-‐1] STP PEC for micro-‐organisms in the STP 1.58E-‐04 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 5a.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial Dustiness: high Duration of exposure: > 4hr/day Use of ventilation: yes, local exhaust ventilation (90% efficiency default ECETOC TRA) Use of respiratory protection: yes, 90 % effectiveness Use of dermal protection: no Concentration in preparation: > 25% manufacturing polymer, < 25% manufacture textiles Exposure Estimations Version 04-03-2013 26 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 PROC Contributing scenarios 5 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) 10 Roller application or brushing 13 Treatment of articles by dipping and pouring 19 Hand-‐mixing with intimate contact and only PPE available Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs, in addition to those listed in section 5a.2.2. 2.50E-‐01 6.86E-‐02 LEV Respiratory protection 1.00E-‐01 1.37 1.60E-‐02 6.86E-‐01 2.50E-‐01 1.41E+01 LEV Respiratory protection LEV Respiratory protection LEV Respiratory protection 5a.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 5a.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in the manufacturing of Polymer dispersion for textiles and textile articles. 5a.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 27 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 5b: Use of textile articles containing polymer dispersion. 5b.1. Exposure Scenario: Use of textile articles containing polymer dispersion. Title Use of textile articles containing polymer dispersion. Sector of use SU 21, 22 Process category PROC 19 Product category Not available Article category AC 5 Environmental release category ERC 11, 12 Specific environmental release category Not available Processes, tasks, activities covered Use of textile articles containing polymer dispersion. 5b.2. Operational conditions and risk management measures 5b.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)9 0.268 tonnes/year (EU risk assessment) Frequency and duration of use Type of release Continuous Environmental exposure may be possible through both particulate releases and through washing. The registered substance will be bound within the polymer matrix which is coated to the back of the textiles and incorporated into the inside of the textile articles. Emission days (days/year) 365 Site specific monitoring data Not available Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor use Emission Factor Water 5E-06 (environmental exposure is dominated by emissions through washing) Emission Factor Air Negligible Emission Factor Soil Negligible Risk Management Measures 9 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 28 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil Not available Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal It is assumed that during service life 80% of emissions to waste water will be directed to an STP. During washing all waste water is directed to an STP. Solid waste after service life will be sent to a landfill. Conditions and measures related to external recovery of waste Not available 5b.2.2. Contributing scenario controlling HUMAN EXPOSURE Product characteristics Substance name: hexabromocyclododecane TRA dustiness: low Physical property: solid Amounts used Covers percentage substance in the product up to 7.7 % (As the primary use of the textiles treated with the back coating is upholstery for furniture and automotive seats the 7.7 w.t-% concentration is considered to represent a worst case value for fabrics). Frequency and duration of use/exposure Covers daily exposures up to 8 hours for workers Covers daily exposures up to 8 hours for consumers Other given operational conditions affecting human exposure Indoor use, human exposure is expected only through textile particulates released during abrasive wear, such exposure is expected to be negligible Technical measures at the article production level (source) to prevent release during service life Not available Technical conditions and measures to control dispersion from source towards the worker Not available Conditions and measures related to personal protection, hygiene and health evaluation No personal protective equipment (PPE) required. Additional good practice advice beyond REACH Chemical Safety Assessment Not available 5b.3. Exposure estimation and reference to its source 5b.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance Solid (encapsulated in articles) Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment Value unit Local total daily intake for humans, total (ECETOC TRA) 7.4E-‐05 [mg.kg-‐1.day-‐1] Local PECs Unit AIR Annual average PEC in air (total) 1.09E-‐09 [mg.m-‐3] WATER, SEDIMENT PEC in surface water during emission episode (dissolved) 3.34E-‐07 [mg.l-‐1] PEC in fresh-‐water sediment during emission episode 3.30E-‐04 [mg.kgwwt-‐1] PEC in seawater during emission episode (dissolved) 3.45E-‐08 [mg.l-‐1] Version 04-03-2013 29 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 PEC in marine sediment during emission episode 3.34E-‐04 [mg.kgwwt-‐1] SOIL, GROUNDWATER PEC in agric. soil (total) 1.54E-‐05 [mg.kgwwt-‐1] PEC in grassland (total) averaged over 180 days 1.54E-‐05 [mg.kgwwt-‐1] PEC in groundwater under agricultural soil 1.92E-‐08 [mg.l-‐1] STP PEC for micro-‐organisms in the STP (ECETOC TRA, ERC 12a) 1.66E-‐08 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 5b.3.2. Exposure estimations contributing scenario for WORKERS/CONSUMERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial/Consumer Dustiness: Low Duration of exposure: > 4hr/day Use of ventilation: no Use of respiratory protection: no Use of dermal protection: no Concentration in preparation: < 25 % Exposure Estimations PROC 14 14 14 14 Contributing scenarios Production of preparations or articles by tabletting, compression, extrusion, palletisation Worker exposure Production of preparations or articles by tabletting, compression, extrusion, palletisation Consumer exposure, clothing Production of preparations or articles by tabletting, compression, extrusion, palletisation Consumer exposure, bedding matresses Production of preparations or articles by tabletting, compression, extrusion, palletisation Consumer exposure, seats, flooring Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs, in addition to those listed in section 5b.2.2. 5E-‐01 1.41E+2 No 1.96 1.03E+03 No 22.8 23.9 No 14.6 1.46E+02 No 5b.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 5b.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in the use of textile articles containing polymer dispersion.. 5b.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER and CONSUMER EXPOSURE The worker and consumer exposure have been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Version 04-03-2013 30 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 31 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 6a: Manufacture of Flexible Elastomeric Foam (FEF) and FEF articles. This exposure scenario covers both the actual manufacturing of Flexible Elastomeric Foam (FEF) and the manufacturing of FEF articles. The manufacture of FEF and FEF articles takes place in closed and partially-open systems. Although opportunity for exposure arises in some systems, such exposure is limited and can be reduced by correct use of personal protective equipment (PPE) and other risk management measures. The formulated FEF is either applied to surfaces by low energy techniques such as rolling or extruded and shaped to form finished articles. As with the manufacture of Expanded Polystyrene (EPS) and Extruded Polystyrene (XPS) articles any exposure to workers is expected through the dermal route during the cutting and handling of the extruded FEF articles. Environmental emission data has been based upon the measured known emission data for the total emission of HBCDD for all uses for the whole EU area and the estimated tonnage for this use. 6a.1. Exposure Scenario: Manufacture of Flexible Elastomeric Foam (FEF) and FEF articles. Title Manufacture of Flexible Elastomeric Foam (FEF) and FEF articles. Sector of use SU 10, 11 Process category Manufacture of FEF PROC 2, 3, 4 Manufacturing of FEF articles 10, 14 Product category PC 32 Article category AC 10 Environmental release category Manufacturing FEF ERC 2, 3 Manufacturing of FEF articles ERC 5 Specific environmental release category Environmental releases are based on the VECAP survey Processes, tasks, activities covered All activities involved in the manufacture of FEF and FEF articles 6a.2. Operational conditions and risk management measures 6a.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)10 400 tonnes/year The annual use per site is based upon a representative total EU tonnage / the fraction of main local source 0.4 (standard EUSES default value). Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data Measured data are available in the VECAP survey Other Operational Conditions of use affecting environmental exposure 10 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 32 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor Emission Factor Water 7E-06 (VECAP Survey) Emission Factor Air 6E-06 (VECAP Survey) Emission Factor Soil 22E-06 (VECAP Survey) Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil Not available Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal Not available Conditions and measures related to external recovery of waste Not available 6a.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: hexabromocyclododecane Physical property: solid Amounts used Covers percentage substance in the product > 25 % Frequency and duration of use/exposure Both manufacture of FEF and FEF articles: Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Both manufacture of FEF and FEF articles: Indoor use Technical conditions and measures at process level (source) to prevent release Manufacture of FEF: Used in closed systems with limited release to air Manufacture of FEF articles: Not available Technical conditions and measures to control dispersion from source towards the worker Manufacture of FEF: Local exhaust ventilation (LEV), 90% efficiency (default ECETOC TRA) Manufacture of FEF articles: Local Exhaust Ventilation (LEV), 90% efficiency (default ECETOC TRA) Conditions and measures related to personal protection, hygiene and health evaluation Manufacture of FEF: Respiratory protection (90% effectiveness), used continuously wherever exposure is possible. Manufacture of FEF articles: Respiratory protection (90% effectiveness), used continuously wherever exposure is possible. Additional good practice advice beyond REACH Chemical Safety Assessment Not available 6a.3. Exposure estimation and reference to its source 6a.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES General parameter set State of the substance Solid Biodegradability Inherently biodegradable Version 04-03-2013 33 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure estimations Indirect exposure of humans via the environment Value unit Local total daily intake for humans, total 6.10E-‐05 [mg.kg-‐1.day-‐1] Local PECs Unit AIR Annual average local PEC in air (total) 1.83E-‐06 [mg.m-‐3] WATER, SEDIMENT Local PEC in surface water during emission episode (dissolved) 9.03E-‐05 [mg.l-‐1] Annual average local PEC in surface water (dissolved) 7.42E-‐05 [mg.l-‐1] Local PEC in fresh-‐water sediment during emission episode 8.91E-‐02 [mg.kgwwt-‐1] Local PEC in seawater during emission episode (dissolved) 4.37E-‐05 [mg.l-‐1] Annual average local PEC in seawater (dissolved) 3.59E-‐05 [mg.l-‐1] Local PEC in marine sediment during emission episode 4.31E-‐02 [mg.kgwwt-‐1] SOIL, GROUNDWATER Local PEC in agric. soil (total) averaged over 30 days 1.35E-‐01 [mg.kgwwt-‐1] Local PEC in agric. soil (total) averaged over 180 days 1.35E-‐01 [mg.kgwwt-‐1] Local PEC in grassland (total) averaged over 180 days 5.34E-‐02 [mg.kgwwt-‐1] Local PEC in groundwater under agricultural soil 1.69E-‐04 [mg.l-‐1] STP PEC for micro-‐organisms in the STP 9.64E-‐04 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] Secondary poisoning 6a.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial Duration of exposure: > 4hr/day Use of ventilation: Local Exhaust Ventilation, 90% efficiency (default ECETOC TRA) Use of respiratory protection: Respiratory protection (90% effectiveness), used continuously wherever possible Use of dermal protection: none Concentration in preparation: > 25% Exposure Estimations PROC Contributing scenarios 2 Use in closed, continuous process with occasional controlled exposure 3 Use in closed batch process (synthesis or formulation) 4 Use in batch and other process (synthesis) where opportunity for exposure arises 10 Roller application or brushing Version 04-03-2013 Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs, in addition to those listed in section 6a.2.2 1.00E-‐02 1.37E-‐01 1.00E-‐02 3.43E-‐02 2.50E-‐01 6.86E-‐01 1.60E-‐02 1.37E00 LEV Respiratory protection LEV Respiratory protection LEV Respiratory protection LEV Respiratory protection 34 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 14 Production of preparations or articles by tabletting, compression, extrusion, pelletisation 1.00E-‐01 3.43E-‐01 LEV Respiratory protection 6a.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 6a.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model, with emissions based on measurements, carried out within the framework of the VECAP survey. Within the conditions described above, there are no further limitations on the use of the substance in the manufacture of Flexible Elastomeric Foam (FEF) and FEF articles. 6a.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 35 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 6b: Use of Flexible Elastomeric Foam (FEF) articles 6b.1. Exposure Scenario: Use of Flexible Elastomeric Foam (FEF) articles Title Use of Flexible Elastomeric Foam (FEF) articles Sector of use SU 19 Process category PROC 21 Product category PC 32 Article category AC 10 Environmental release category ERC 11 Specific environmental release category Not available Processes, tasks, activities covered All activities involved in the use of FEF articles 6b.2. Operational conditions and risk management measures 6b.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)11 100 kg/site (worst case estimate) Frequency and duration of use Type of release Continuous Emission days (days/year) 365 Site specific monitoring data Not available Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor Emission Factor Water 5E-04 Emission Factor Air 5E-04 Emission Factor Soil 0 Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil Not available Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 11 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 36 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal Environmental exposure from use and installation of the FEF articles is expected to be negligible as minimal quantities of waste will be produced due to cost considerations. Any wastes are likely to be sent to landfill, leachates are unlikely to be formed due to the highly insoluble nature of the registered substance in water. Conditions and measures related to external recovery of waste Not available 6b.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: hexabromocyclododecane Physical property: solid Amounts used Covers percentage substance in the product up to 10 % (worst case estimate) Frequency and duration of use/exposure Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Indoor use Technical conditions and measures at process level (source) to prevent release Not available Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation (LEV), 90% efficiency (default ECETOC TRA) Conditions and measures related to personal protection, hygiene and health evaluation Not available Additional good practice advice beyond REACH Chemical Safety Assessment Not available 6b.3. Exposure estimation and reference to its source 6b.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation Expert judgement Considerations The soft rubber which FEF is made from ensures that the registered substance will be contained within the polymer matrix during installation and use. In addition to this no particulate emissions will be generated from the cutting of FEF articles during installation or removal. There is therefore no anticipated release of HBCDD during the use or life-‐ cycle of FEF articles. Wastes generated from cutting and installation of the FEF articles and at the end of the service-‐life are likely to be sent to landfill. The substance has a high molecular weight and is therefore expected to remain trapped within the polymer matrix. Should any of the HBCDD be released through degradation of the polymer matrix leachates are unlikely to be formed, based upon the highly insoluble nature of the substance in water. Exposure estimations Indirect exposure of humans via the environment Value Unit Local total daily intake for humans, total (ECETOC TRA, ERC 11) 1.01E-‐05 [mg.kg-‐1.day-‐1] Local PECs Unit AIR Annual average local PEC in air (total) 0 [mg.m-‐3] WATER, SEDIMENT Local PEC in surface water during emission episode (dissolved) 0 [mg.l-‐1] Annual average local PEC in surface water (dissolved) 0 [mg.l-‐1] Version 04-03-2013 37 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Local PEC in fresh-‐water sediment during emission episode 0 [mg.kgwwt-‐1] Local PEC in seawater during emission episode (dissolved) 0 [mg.l-‐1] Annual average local PEC in seawater (dissolved) 0 [mg.l-‐1] Local PEC in marine sediment during emission episode 0 [mg.kgwwt-‐1] SOIL, GROUNDWATER Local PEC in agric. soil (total) averaged over 30 days 0 [mg.kgwwt-‐1] Local PEC in agric. soil (total) averaged over 180 days 0 [mg.kgwwt-‐1] Local PEC in grassland (total) averaged over 180 days 0 [mg.kgwwt-‐1] Local PEC in groundwater under agricultural soil 0 [mg.l-‐1] STP PEC for micro-‐organisms in the STP 0 [mg.l-‐1] Conc in fish for secondary poisoning (freshwater) 0 [mg.kgwwt-‐1] Conc in earthworms from agricultural soil 0 [mg.kg-‐1] Conc in fish for secondary poisoning (marine) 0 [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators 0 [mg.kgwwt-‐1] Secondary poisoning 6b.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA v2 General parameter set Type of setting: Industrial Duration of exposure: > 4hr/day Use of ventilation: Local Exhaust Ventilation, 90% efficiency (default ECETOC TRA) Use of respiratory protection: none Use of dermal protection: none Concentration in preparation: < 10% Exposure Estimations PROC 21 Contributing scenarios Low energy manipulation of substances bound in materials and/or articles Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs 3.00 2.83 LEV 6b.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 6b.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using expert judgement. Within the conditions described above, there are no further limitations on the use of the substance in Flexible Elastomeric Foam articles 6b.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. Version 04-03-2013 38 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Exposure Scenario 7: Additional formulation use 7.1. Exposure Scenario: Additional formulation use Title Additional formulation use. Sector of use SU 3, 10 Process category PROC 2, 6, 8a, 8b, 9, 10 Product category PC 19 Article category AC 13 Environmental release category ERC 2, 3, 10 a, 11a Specific environmental release category Emission factors are based on the VECAP survey Processes, tasks, activities covered This scenario covers the formulation of HBCDD into polymer preparations in closed and partially open systems that are not covered by the previous exposure scenarios. 7.2. Operational conditions and risk management measures 7.2.1. Contributing scenario controlling ENVIRONMENTAL EXPOSURE Operational conditions Amounts used Tonnage used at a local scale (tonnes/year)12 400 tonnes/year (based upon a total EU tonnage of 1000 tpa and a fraction of main local source of 0.4 (standard EUSES) Frequency and duration of use Type of release Continuous Emission days (days/year) 300 Site specific monitoring data Measured data are available in the VECAP Survey Other Operational Conditions of use affecting environmental exposure Local freshwater dilution factor 10 Flow rate of the receiving surface water (m3/day) 18,000 Indoor/outdoor use of the substance Indoor Emission Factor Water 7E-06 Emission Factor Air 6E-06 Emission Factor Soil 22E-06 Risk Management Measures Technical on-‐site conditions and measures to limit or reduce discharges, air emissions and releases to soil Not available Conditions and measures related to waste water treatment Size of STP (m3/day) 2,000 12 This is the maximum tonnage that is allowed to be used by the Downsteam User on his site Version 04-03-2013 39 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Degradation potential of the substance Inherently biodegradable Conditions and measures related to external treatment of waste for disposal Not available Conditions and measures related to external recovery of waste Not available 7.2.2. Contributing scenario controlling WORKER EXPOSURE Product characteristics Substance name: hexabromocyclododecane Physical property: solid Amounts used Not available Frequency and duration of use/exposure Covers daily exposures up to 8 hours Other given operational conditions affecting workers exposure Indoor use Technical conditions and measures at process level (source) to prevent release Not available Technical conditions and measures to control dispersion from source towards the worker Local Exhaust Ventilation (LEV), 90% efficiency (default ECETOC TRA) Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection (90 % effectiveness), to be used wherever exposure is possible Additional good practice advice beyond REACH Chemical Safety Assessment Not available 7.3. Exposure estimation and reference to its source 7.3.1. Exposure estimations contributing scenario for ENVIRONMENT Tool used for evaluation EUSES vs 2.1 General parameter set State of the substance Solid Biodegradability Inherently biodegradable Exposure estimations Indirect exposure of humans via the environment Value Unit Local total daily intake for humans, total (ECETOC TRA) 1.24E-‐04 [mg.kg-‐1.day-‐1] Local PECs Unit AIR Annual average local PEC in air (total) 1.83E-‐06 [mg.m-‐3] WATER, SEDIMENT Local PEC in surface water during emission episode (dissolved) 9.03E-‐05 [mg.l-‐1] Annual average local PEC in surface water (dissolved) 7.42E-‐05 [mg.l-‐1] Local PEC in fresh-‐water sediment during emission episode 8.91E-‐02 [mg.kgwwt-‐1] Local PEC in seawater during emission episode (dissolved) 4.37E-‐05 [mg.l-‐1] Annual average local PEC in seawater (dissolved) 3.59E-‐05 [mg.l-‐1] Local PEC in marine sediment during emission episode 4.31E-‐02 [mg.kgwwt-‐1] SOIL, GROUNDWATER Local PEC in agric. soil (total) averaged over 30 days 1.35E-‐01 [mg.kgwwt-‐1] Local PEC in agric. soil (total) averaged over 180 days 1.35E-‐01 [mg.kgwwt-‐1] Local PEC in grassland (total) averaged over 180 days 5.34E-‐02 [mg.kgwwt-‐1] Local PEC in groundwater under agricultural soil 1.69E-‐04 [mg.l-‐1] STP PEC for micro-‐organisms in the STP 9.64E-‐04 [mg.l-‐1] Version 04-03-2013 40 EC number: 247-148-4 Substance name: Hexabromocyclododecane CAS number: 25637-99-4 Secondary poisoning Conc in fish for secondary poisoning (freshwater) n.a. [mg.kgwwt-‐1] Conc in earthworms from agricultural soil n.a. [mg.kg-‐1] Conc in fish for secondary poisoning (marine) n.a. [mg.kgwwt-‐1] Conc in fish-‐eating marine top-‐predators n.a. [mg.kgwwt-‐1] 7.3.2. Exposure estimations contributing scenario for WORKERS Tool used for evaluation ECETOC TRA vs 2 Exposure to workers is not expected to occur during formulation of polymer preparations due to the low vapour pressure of the registered substance. General parameter set Type of setting: Industrial Duration of exposure: > 4hr/day Use of ventilation: Local Exhaust Ventilation, 90% efficiency (default ECETOC TRA) Use of respiratory protection: Respiratory protection , 90% efficiency Use of dermal protection: none Exposure Estimations PROC Contributing scenarios 2 Use in closed, continuous process with occasional controlled exposure 6 Calendering operations 8a 8b 9 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) 10 Roller application or brushing 24c High (mechanical) energy work-‐up of substances bound in materials and/or articles Predicted Inhalative Exposure - (mg/m3) Predicted Dermal exposure (mg/kg/d) RMMs, in addition to those listed in section 7.2.2 1.00E-‐02 1.37E-‐01 2.50E-‐01 1.37 5.00E-‐01 1.37E-‐01 LEV Respiratory protection LEV Respiratory protection LEV Respiratory protection 1.25E-‐01 6.86E-‐01 LEV Respiratory protection 2.00E-‐01 6.86E-‐01 1.60E-‐02 1.37 2.00E-‐01 2.83E-‐01 LEV Respiratory protection LEV Respiratory protection LEV Respiratory protection 7.4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES 7.4.1. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for ENVIRONMENTAL EXPOSURE Environmental exposure has been evaluated using the EUSES model. Within the conditions described above, there are no further limitations on the use of the substance in additional formulation use. 7.4.2. Guidance to DU to evaluate whether he works inside the boundaries set by contributing scenario for WORKER EXPOSURE The workers exposure has been evaluated using ECETOC TRA integrated tool version 2. Evaluate whether you work within the boundaries of the operational conditions and risk management measures described in the tables above. Within those conditions safe use was shown. Should you however not be able to demonstrate compliance with the conditions described above, scaling of the results is possible using the ECETOC TRA model that was run to generate the above assessment. 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