OF CONTENTS FULL PUBLIC REPORT 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 4 4. INTRODUCTION AND USE INFORMATION 4 5. PROCESS AND RELEASE INFORMATION 4 5.1. Distribution, transport and storage 4 5.2. Operation description 4 5.3. Occupational exposure 5 5.4. Release 5 5.5. Disposal 5 5.6. Public exposure 6 6. PHYSICAL AND CHEMICAL PROPERTIES 6 7. TOXICOLOGICAL INVESTIGATIONS 9 7.1. Acute toxicity oral 9 – 7.2. Acute toxicity dermal 9 – 7.3. Irritation skin 10 – 7.4. Irritation eye 10 – 7.5. Skin sensitisation local lymph node assay (LLNA) 11 – 7.6. Repeat dose toxicity 12 7.7. Genotoxicity bacteria 14 – 7.8. Genotoxicity in vitro 16 – 7.9. Genotoxicity in vivo 17 – 7.10 Genotoxicity in vivo 17 – 8. ENVIRONMENT 19 8.1. Environmental fate 19 8.1.1. Ready biodegradability 19 8.1.2. Bioaccumulation 19 8.2. Ecotoxicological investigations 19 8.2.1. Acute toxicity to fish 19 8.2.2. toxicity to aquatic invertebrates 20 8.2.3. growth inhibition test 21 8.2.4. Inhibition of microbial activity 22 9. RISK ASSESSMENT 23 9.1. Environment 23 9.1.1. Environment exposure assessment 23 – 9.1.2. Environment effects assessment 23 – 9.1.3. Environment risk characterisation 23 – 9.2. Human health 23 9.2.1. Occupational health and safety exposure assessment 24 – 9.2.2. Public health exposure assessment 24 – 9.2.3. Human health effects assessment 24 – 9.2.4. Occupational health and safety risk characterisation 25 – 9.2.5. Public health risk characterisation 26 – 10. CONCLUSIONS ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND – HUMANS 26 10.1. Hazard classification 26 10.2. Environmental risk assessment 26 10.3. Human health risk assessment 26 10.3.1. Occupational health and safety 26 10.3.2. Public health 27 11. MATERIAL SAFETY DATA SHEET 27 11.1. Material Safety Data Sheet 27 11.2. Label 27 12. RECOMMENDATIONS 27 12.1. Secondary notification 28 13. BIBLIOGRAPHY 28
OF CONTENTS FULL PUBLIC REPORT 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 4 4. INTRODUCTION AND USE INFORMATION 4 5. PROCESS AND RELEASE INFORMATION 4 5.1. Distribution, transport and storage 4 5.2. Operation description 4 5.3. Occupational exposure 5 5.4. Release 5 5.5. Disposal 5 5.6. Public exposure 6 6. PHYSICAL AND CHEMICAL PROPERTIES 6 7. TOXICOLOGICAL INVESTIGATIONS 9 7.1. Acute toxicity – oral 9 7.2. Acute toxicity – dermal 9 7.3. Irritation – skin 10 7.4. Irritation – eye 10 7.5. Skin sensitisation – local lymph node assay (LLNA) 11 7.6. Repeat dose toxicity 12 7.7. Genotoxicity – bacteria 14 7.8. Genotoxicity – in vitro 16 7.9. Genotoxicity – in vivo 17 7.10 Genotoxicity – in vivo 17 8. ENVIRONMENT 19 8.1. Environmental fate 19 8.1.1. Ready biodegradability 19 8.1.2. Bioaccumulation 19 8.2. Ecotoxicological investigations 19 8.2.1. Acute toxicity to fish 19 8.2.2. toxicity to aquatic invertebrates 20 8.2.3. growth inhibition test 21 8.2.4. Inhibition of microbial activity 22 9. RISK ASSESSMENT 23 9.1. Environment 23 9.1.1. Environment – exposure assessment 23 9.1.2. Environment – effects assessment 23 9.1.3. Environment – risk characterisation 23 9.2. Human health 23 9.2.1. Occupational health and safety – exposure assessment 24 9.2.2. Public health – exposure assessment 24 9.2.3. Human health – effects assessment 24 9.2.4. Occupational health and safety – risk characterisation 25 9.2.5. Public health – risk characterisation 26 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 26 10.1. Hazard classification 26 10.2. Environmental risk assessment 26 10.3. Human health risk assessment 26 10.3.1. Occupational health and safety 26 10.3.2. Public health 27 11. MATERIAL SAFETY DATA SHEET 27 11.1. Material Safety Data Sheet 27 11.2. Label 27 12. RECOMMENDATIONS 27 12.1. Secondary notification 28 13. BIBLIOGRAPHY 28