TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 5 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. COMPOSITION 6 4. PHYSICAL AND CHEMICAL PROPERTIES 6 5. INTRODUCTION AND USE INFORMATION 7 6. HUMAN HEALTH IMPLICATIONS 8 6.1. Exposure Assessment 8 6.1.1. Occupational Exposure 8 6.1.2. Public Exposure 8 6.2. Human Health Effects Assessment 9 6.3. Human Health Risk Characterisation 10 6.3.1. Occupational Health and Safety 10 6.3.2. Public Health 11 7. ENVIRONMENTAL IMPLICATIONS 11 7.1. Environmental Exposure & Fate Assessment 11 7.1.1. Environmental Exposure 11 7.1.2. Environmental Fate 11 7.1.3. Predicted Environmental Concentration (PEC) 12 7.2. Environmental Effects Assessment 12 7.2.1. Predicted No-Effect Concentration 13 7.3. Environmental Risk Assessment 13 Appendix A: Physical and Chemical Properties 14 Appendix B: Toxicological Investigations 16 B.1. Acute toxicity oral 16 – B.2. Irritation skin 16 – B.3. Irritation eye 17 – B.4. Skin sensitisation mouse local lymph node assay (LLNA) 17 – B.5. Repeat dose toxicity 18 B.6. Genotoxicity bacteria 20 – B.7. Genotoxicity in vitro 21 – B.8. Genotoxicity in vitro 22 – B.9. Genotoxicity in vivo 23 – B.10. Developmental toxicity 23 B.11. Metabolism 25 Appendix C: Environmental Fate and Ecotoxicological Investigations 26 C.1. Environmental Fate 26 C.1.1. Ready biodegradability 26 C.2. Ecotoxicological Investigations 26 C.2.1. Acute toxicity to fish 26 C.2.2. Acute toxicity to aquatic invertebrates 27 C.2.3. Algal growth inhibition test 28 C.2.4. Inhibition of microbial activity 29 BIBLIOGRAPHY 30
TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 5 1. APPLICANT AND NOTIFICATION DETAILS 5 2. IDENTITY OF CHEMICAL 5 3. COMPOSITION 6 4. PHYSICAL AND CHEMICAL PROPERTIES 6 5. INTRODUCTION AND USE INFORMATION 7 6. HUMAN HEALTH IMPLICATIONS 8 6.1. Exposure Assessment 8 6.1.1. Occupational Exposure 8 6.1.2. Public Exposure 8 6.2. Human Health Effects Assessment 9 6.3. Human Health Risk Characterisation 10 6.3.1. Occupational Health and Safety 10 6.3.2. Public Health 11 7. ENVIRONMENTAL IMPLICATIONS 11 7.1. Environmental Exposure & Fate Assessment 11 7.1.1. Environmental Exposure 11 7.1.2. Environmental Fate 11 7.1.3. Predicted Environmental Concentration (PEC) 12 7.2. Environmental Effects Assessment 12 7.2.1. Predicted No-Effect Concentration 13 7.3. Environmental Risk Assessment 13 Appendix A: Physical and Chemical Properties 14 Appendix B: Toxicological Investigations 16 B.1. Acute toxicity – oral 16 B.2. Irritation – skin 16 B.3. Irritation – eye 17 B.4. Skin sensitisation – mouse local lymph node assay (LLNA) 17 B.5. Repeat dose toxicity 18 B.6. Genotoxicity – bacteria 20 B.7. Genotoxicity – in vitro 21 B.8. Genotoxicity – in vitro 22 B.9. Genotoxicity – in vivo 23 B.10. Developmental toxicity 23 B.11. Metabolism 25 Appendix C: Environmental Fate and Ecotoxicological Investigations 26 C.1. Environmental Fate 26 C.1.1. Ready biodegradability 26 C.2. Ecotoxicological Investigations 26 C.2.1. Acute toxicity to fish 26 C.2.2. Acute toxicity to aquatic invertebrates 27 C.2.3. Algal growth inhibition test 28 C.2.4. Inhibition of microbial activity 29 BIBLIOGRAPHY 30
STD1583-FINAL-FR.DOCX