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Annexes Table of Content Annexes Table of content Annexes ................................................................................................................... 1 Table of content ........................................................................................................ 1 List of tables ............................................................................................................. 6 List of figures ............................................................................................................ 8 Annex A: Manufacture and uses ................................................................................. 10 A.1. Manufacture, import and export ........................................................................... 10 A.1.1. Manufacture, import and export of textiles and leather ........................................ 10 A.1.2. Estimated volumes on of the chemicals used in textile and leather articles ............. 12 A.2. Uses ................................................................................................................. 13 A.2.1. The use of chemicals in textile and leather processing ......................................... 13 A.2.1.1. Textile processing ................................................................................... 13 A.2.1.2. Leather processing ................................................................................. 19 A.2.1.3. Textile and leather formulations ............................................................... 20 A.2.1.4. Chemicals used in textile and leather ........................................................ 23 A.2.2. Identification of relevant chemicals in finished textile and leather products ............ 30 A.2.2.1. Screening of substances with a possible use in textile and leather ................ 30 A.2.2.2. Identification of substances in finished articles ........................................... 31 A.3. Uses advised against by the registrants ................................................................ 32 Annex B: Information on hazard and risk..................................................................... 33 B.1. Identity of the substance(s) and physical and chemical properties ........................... 33 B.1.1. Name and other identifiers of the substance(s) ................................................... 33 B.1.2. Composition of the substance(s) ....................................................................... 36 B.1.3. Physicochemical properties ............................................................................... 37 B.1.4. Justification for grouping .................................................................................. 39 B.2. Manufacture and uses (summary) ........................................................................ 39 B.3. Classification and labelling .................................................................................. 39 1 B.3.1. Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) ........................................................................................................ 39 B.3.2. Classification and labelling in classification and labelling inventory/ Industry’s self classification(s) and labelling1 .............................................................................. 39 B.4. Environmental fate properties ............................................................................. 39 B.5. Human health hazard assessment ........................................................................ 39 B 5.1 Skin irritation ................................................................................................. 39 B 5.2 Skin corrosion ................................................................................................. 39 B.5.3. Skin sensitisation ............................................................................................ 39 B.5.3.1. Development of allergic contact dermatitis ................................................ 40 B.5.3.2. Allergic contact dermatitis acquired from textiles and leather ....................... 40 B.5.3.3. Diagnosis of allergic contact dermatitis ...................................................... 41 B.5.3.4. Prevention of allergic contact dermatitis .................................................... 41 B.5.3.5. Classification of skin sensitisers according to the CLP Regulation .................. 41 B.5.3.6. The dose-response relationship of skin sensitisers....................................... 41 B.5.4. Reference dose ............................................................................................... 43 B.5.4.1. Information gathering and search strategy ................................................. 43 B.5.4.2. Hazard information related to targeted substances or groups of substances ... 44 B.5.4.3. Default elicitation threshold dose .............................................................. 47 B.5.4.4 Conclusion on reference dose ................................................................... 48 B.6. Human health hazard assessment of physicochemical properties ............................. 48 B.6.1. Explosivity ..................................................................................................... 48 B.6.2. Flammability................................................................................................... 48 B.6.3. Oxidising potential .......................................................................................... 48 B.7. Environmental hazard assessment ....................................................................... 48 B.8. PBT and vPvB assessment ................................................................................... 49 B.9. Exposure assessment ......................................................................................... 49 B.9.1. General information on releases and exposure .................................................... 49 B.9.1.1. Summary of the existing legal requirements .............................................. 49 B.9.1.2. Summary of the effectiveness of the implemented operational conditions and risk management measures ..................................................................... 49 2 B.9.2. Uses: Textile ............................................................................................... 53 B.9.2.1. General information on exposure to chemical substances from textile ........... 53 B.9.2.2. Information gathering and search strategy ................................................. 54 B.9.2.3. Exposure information related to targeted substances or groups of substances 55 B.9.2.4. Exposure assessment .............................................................................. 62 B.9.2.5. Exposure scenario ................................................................................... 65 B.9.2.6. Workers exposure .................................................................................. 66 B.9.2.7. Consumer exposure ................................................................................ 66 B 9.2.8. Indirect exposure of humans via the environment ...................................... 66 B.9.2.9. Environmental exposure .......................................................................... 66 B.9.3. Uses: Leather, hide and fur ........................................................................... 66 B.9.3.1. General information on exposure to chemical substances in leather, hide and fur 66 B.9.3.2. Information gathering and search strategy ................................................. 67 B.9.3.3. Exposure information related to targeted substances or groups of substances 67 B.9.3.4. Exposure assessment .............................................................................. 73 B.9.3.5. Exposure scenario ................................................................................... 77 B.9.3.6. Workers exposure .................................................................................. 77 B.9.3.7. Consumer exposure ................................................................................ 77 B 9.3.8. Indirect exposure of humans via the environment ...................................... 77 B.9.3.9. Environmental exposure .......................................................................... 77 B.9.4. Other sources (for example natural sources, unintentional releases) ...................... 77 B.9.5. Overall environmental exposure assessment ...................................................... 78 B.9.6. Combined human exposure assessment ............................................................. 78 B.10. Risk characterisation ........................................................................................ 78 B.10.1. Human health risk from exposure to skin sensitisers in textile articles .................. 79 B.10.1.1. Equations to derive concentration limits in textile ................................ 79 B.10.1.2. Concentration limits for substances or groups of substances with information on elicitation threshold doses and migration: Quantitative, substance specific approach ..................................................................... 80 3 B.10.1.3. Concentration limits for substances/groups of substances with information on elicitation threshold doses or migration: Quantitative, substance semi- specific approach .................................................................................... 81 B.10.1.4.
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