TABLE OF CONTENTS Full Public Report 3 1. APPLICANT AND NOTIFICATION DETAILS 3 2. IDENTITY OF CHEMICAL 3 3. COMPOSITION 4 4. PHYSICAL AND CHEMICAL PROPERTIES 4 5. INTRODUCTION AND USE INFORMATION 5 6. HUMAN HEALTH IMPLICATIONS 6 6.1 Exposure assessment 6 6.1.1 Occupational exposure 6 6.1.2. Public exposure 6 6.2 Human health effects assessment 6 Acute toxicity, Irritation and Sensitisation 7 Health hazard classification 7 6.3. health risk characterisation 8 6.3.1. Occupational health and safety 8 6.3.2. Public health 8 7. ENVIRONMENTAL IMPLICATIONS 8 7.1. Environmental Exposure & Fate Assessment 8 7.1.1 Environmental Exposure 8 7.1.2 Environmental fate 9 7.1.3 Predicted Environmental Concentration (PEC) 9 7.2. Environmental effects assessment 9 7.2.1 Predicted No-Effect Concentration 9 7.3. Environmental risk assessment 9 8. CONCLUSIONS AND REGULATORY OBLIGATIONS 9 Hazard classification 9 Human health risk assessment 9 Environmental risk assessment 9 Recommendations 10 Regulatory Obligations 10 Appendix A: Physical and Chemical Properties 12 Appendix B: Toxicological Investigations 14 B.1. toxicity – oral 14 B.2. Acute toxicity – dermal 14 B.3. Irritation - skin 15 B.4. Irritation – eye 15 B.5. Skin sensitisation 16 B.6. Repeat dose toxicity 17 B.7. Genotoxicity – bacteria 18 B.8. Genotoxicity – in vitro 18 B.9. Genotoxicity – in vivo 19 Appendix C: Environmental Fate and Ecotoxicological Investigations 21 C.1. Environmental Fate 21 C.1.1. Ready biodegradability 21 C.2. Ecotoxicological Investigations 21 C.2.1. Acute toxicity to fish 21 C.2.2. Acute toxicity to aquatic invertebrates 22 C.2.3. Algal growth inhibition test 23 Bibliography 24
Vehicle Dimethyl sulfoxide Remarks - Method No significant protocol variations. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 >2500 - Negative Test 2 - Negative Present Test 1 >2500 >2500 - Negative Test 2 >2500 - Negative Remarks - Results No mutagenic effects were observed with or without metabolic activation. Results with positive controls demonstrated the validity of the test system. The notified chemical was not mutagenic to bacteria under the conditions of the test. JAI Research Foundation (2009j) Genotoxicity – in Notified chemical OECD TG 476 In vitro Mammalian Cell Gene Mutation Test. Species/Strain Chinese hamster ovary Cell Type/Cell Line Cell line CHO-K1 Metabolic Activation System Extract of rat liver (treated with Aroclor 1254) called S9 fraction was used. The S9 fraction was buffered and supplemented with the essential co-factors β NADP, KCl and glucose-6-phosphate to form S9 mix. Vehicle Dimethyl sulfoxide Remarks - Method No significant protocol variations. Concentrations for testing were selected on the basis of a preliminary cytotoxicity test. S9 was used at 2% in Test 2 with metabolic activation, and at 1% in the remaining tests. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Expression Time Selection Time Absent Test 1 31.25, 62.5*, 125*, 250*, 500* 4 h 24 h 48 h Test 2 31.25, 62.5*, 125*, 250*, 500* 23 h 24 h 48 h Present Test 1 31.25, 62.5*, 125*, 250*, 500* 4 h 24 h 48 h Test 2 31.25, 62.5*, 125*, 250*, 500* 4 h 24 h 48 h *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent >500 Test 1 >500 >500 Negative