OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 7 1. APPLICANT AND NOTIFICATION DETAILS 7 2. IDENTITY OF CHEMICAL 7 3. COMPOSITION 7 4. PHYSICAL AND CHEMICAL PROPERTIES 8 5. INTRODUCTION AND USE INFORMATION 8 6. HUMAN HEALTH IMPLICATIONS 9 6.1. Exposure Assessment 9 6.1.1. Occupational Exposure 10 6.1.2. Public Exposure 10 6.2. Human Health Effects Assessment 10 6.3. Human Health Risk Characterisation 13 6.3.1. Occupational Health and Safety 13 6.3.2. Public Health 14 7. ENVIRONMENTAL IMPLICATIONS 14 7.1. Environmental Exposure & Fate Assessment 14 7.1.1. Environmental Exposure 14 7.1.2. Environmental Fate 16 7.1.3. Predicted Environmental Concentration (PEC) 17 7.2. Environmental Effects Assessment 20 7.2.1. Predicted No-Effect Concentration 20 7.3. Environmental Risk Assessment 21 Appendix A: Physical and Chemical Properties 23 Appendix B: Toxicological Investigations 24 B.1. Acute toxicity oral 24 – B.2. Acute toxicity oral 24 – B.3. Acute toxicity oral 25 – B.4. Acute toxicity dermal 25 – B.5. Acute toxicity dermal 26 – B.6. Acute toxicity inhalation 26 – B.7. Irritation skin 27 – B.8. Irritation skin 27 – B.9. Irritation skin 28 – B.10. Irritation eye 28 – B.11. Irritation eye 29 – B.12. Skin sensitisation mouse local lymph node assay (LLNA) 29 – B.13. Skin sensitisation mouse local lymph node assay (LLNA) 30 – B.14. Genotoxicity bacteria 31 – B.15. Toxicity to reproduction 90-day gavage study with one generation study 32 – B.16. Toxicity to reproduction one generation study 35 – Appendix C: Environmental Fate and Ecotoxicological Investigations 37 C.1. Environmental Fate 37 C.1.1. Ready biodegradability 37 C.2. Ecotoxicological Investigations 37 C.2.1. Acute toxicity to fish (Test 1) 37 C.2.2. Acute toxicity to fish (Test 2) 38 C.2.3. Acute toxicity to aquatic invertebrates 39 C.2.4. Algal growth inhibition test 39 Appendix D: Toxicology of Perfluorohexanoic Acid (PFHxA) 41 BIBLIOGRAPHY 43
OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 7 1. APPLICANT AND NOTIFICATION DETAILS 7 2. IDENTITY OF CHEMICAL 7 3. COMPOSITION 7 4. PHYSICAL AND CHEMICAL PROPERTIES 8 5. INTRODUCTION AND USE INFORMATION 8 6. HUMAN HEALTH IMPLICATIONS 9 6.1. Exposure Assessment 9 6.1.1. Occupational Exposure 10 6.1.2. Public Exposure 10 6.2. Human Health Effects Assessment 10 6.3. Human Health Risk Characterisation 13 6.3.1. Occupational Health and Safety 13 6.3.2. Public Health 14 7. ENVIRONMENTAL IMPLICATIONS 14 7.1. Environmental Exposure & Fate Assessment 14 7.1.1. Environmental Exposure 14 7.1.2. Environmental Fate 16 7.1.3. Predicted Environmental Concentration (PEC) 17 7.2. Environmental Effects Assessment 20 7.2.1. Predicted No-Effect Concentration 20 7.3. Environmental Risk Assessment 21 Appendix A: Physical and Chemical Properties 23 Appendix B: Toxicological Investigations 24 B.1. Acute toxicity – oral 24 B.2. Acute toxicity – oral 24 B.3. Acute toxicity – oral 25 B.4. Acute toxicity – dermal 25 B.5. Acute toxicity – dermal 26 B.6. Acute toxicity – inhalation 26 B.7. Irritation – skin 27 B.8. Irritation – skin 27 B.9. Irritation – skin 28 B.10. Irritation – eye 28 B.11. Irritation – eye 29 B.12. Skin sensitisation – mouse local lymph node assay (LLNA) 29 B.13. Skin sensitisation – mouse local lymph node assay (LLNA) 30 B.14. Genotoxicity – bacteria 31 B.15. Toxicity to reproduction – 90-day gavage study with one generation study 32 B.16. Toxicity to reproduction – one generation study 35 Appendix C: Environmental Fate and Ecotoxicological Investigations 37 C.1. Environmental Fate 37 C.1.1. Ready biodegradability 37 C.2. Ecotoxicological Investigations 37 C.2.1. Acute toxicity to fish (Test 1) 37 C.2.2. Acute toxicity to fish (Test 2) 38 C.2.3. Acute toxicity to aquatic invertebrates 39 C.2.4. Algal growth inhibition test 39 Appendix D: Toxicology of Perfluorohexanoic Acid (PFHxA) 41 BIBLIOGRAPHY 43
STD-1409-FR-Final.docx