TABLE OF CONTENTS SUMMARY 3 CONCLUSIONS AND REGULATORY OBLIGATIONS 3 ASSESSMENT DETAILS 6 1. APPLICANT AND NOTIFICATION DETAILS 6 2. IDENTITY OF CHEMICAL 6 3. COMPOSITION 7 4. PHYSICAL AND CHEMICAL PROPERTIES 7 5. INTRODUCTION AND USE INFORMATION 8 6. HUMAN HEALTH IMPLICATIONS 9 6.1. Exposure Assessment 9 6.1.1. Occupational Exposure 9 6.1.2. Public Exposure 9 6.2. Human Health Effects Assessment 10 6.3. Human Health Risk Characterisation 12 6.3.1. Occupational Health and Safety 12 6.3.2. Public Health 12 7. ENVIRONMENTAL IMPLICATIONS 13 7.1. Environmental Exposure & Fate Assessment 13 7.1.1. Environmental Exposure 13 7.1.2. Environmental Fate 13 7.1.3. Predicted Environmental Concentration (PEC) 14 7.2. Environmental Effects Assessment 14 7.2.1. Predicted No-Effect Concentration 14 7.3. Environmental Risk Assessment 15 Appendix A: Physical and Chemical Properties 16 Appendix B: Toxicological Investigations 18 B.1. Acute toxicity – oral 18 B.2. Acute toxicity – dermal 18 B.3. Acute toxicity – inhalation 19 B.4. Irritation – skin 20 B.5. Irritation – eye 20 B.6. Skin sensitisation – mouse local lymph node assay (LLNA) 21 B.7. Repeat dose toxicity 22 B.8. Genotoxicity – bacteria 24 B.9. Genotoxicity – in vitro 25 B.10. Genotoxicity – in vivo 26 Appendix C: Environmental Fate and Ecotoxicological Investigations 28 C.1. Environmental Fate 28 C.1.1. Ready biodegradability 28 C.2. Ecotoxicological Investigations 28 C.2.1. Acute toxicity to fish 28 C.2.2. Acute toxicity to fish 29 C.2.3. Acute toxicity to aquatic invertebrates 29 C.2.4. Algal growth inhibition test 30 BIBLIOGRAPHY 32
Appendix A: Physical and Chemical Properties Melting Point/Freezing Point < -50 °C OECD TG 102 Melting Point/Melting Range (1995). Remarks No congealing was noted down to the temperature of -50.0 ° in the preliminary test. Givaudan (2011a) Boiling Point 205 °C at 101.3 kPa OECD TG 103 Boiling Point (1995). Remarks A capillary tube was used according to the Siwoloboff principle. Givaudan (2011b) Density 961 ± 1 kg/m3 at 20 °C OECD TG 109 Density of Liquids and Solids (1995). Remarks The oscillating densitometer method was used. Givaudan (2011c) Vapour Pressure 0.04 kPa at 20 °C OECD TG 104 Vapour Pressure (2006). Remarks The gas saturation method was used. Givaudan (2011d) Water Solubility 1.05 g/L at 20 °C OECD TG 105 Water Solubility. Remarks Flask Method Givaudan (2011f) Hydrolysis as a Function of pH t½ > 1 year at 25 °C at pH 4, 7, 9 OECD TG 111 Hydrolysis as a Function of pH. pH T (°C) t½ (years) 4 25 > 1 7 25 > 1 9 25 > 1 Remarks HPLC method. A nominal concentration of 120 mg/L was prepared in acetone. The test was carried out at 50 °C with samples taken after 0, 18, 24, 120 and 144 hours. Less than 10% hydrolysis was observed after 120 h at 50°C at pH 4, 7 and 9 and therefore the estimated half-life at 25°C is > 1 year. Givaudan (2011g) Partition Coefficient log Pow = 2.4 at 35 °C OECD TG 117 Partition Coefficient (n-octanol/water). Remarks HPLC Method Givaudan (2011h)
Test – Semi Static. Species Daphnia magna Exposure Period 48 hours Auxiliary Solvent None Water Hardness 150 mg CaCO3/L Analytical Monitoring Gas chromatography Remarks - Method Conducted in accordance with the test guidelines above, and in compliance with GLP standards and principles. Concentration mg/L Number of D. magna Immobilised (%) Nominal Actual 24 h [acute] 48 h [acute] Control ND 20 0 0 6.5 ND 20 0 0 13 12 20 0 0 25.0 23 20 0 10 50.0 47 20 100 100 100.0 99 20 100 100 LC50 31 mg/L (95% CI 27-37 mg/L) at 48 h NOEC 12 mg/L at 48 h Remarks - Results All validity criteria of the test guideline were satisfied. The test solutions were renewed daily during the 48 h test period. The 48 h EC50 and NOEC for Daphnia were determined to be 31 mg/L (95% CI 27–37 mg/L) and 12 mg/L, respectively, based on mean measured concentrations. The test substance is considered to be harmful to aquatic invertebrates. Harlan (2012c) Algal growth inhibition test Mixture of notified chemicals OECD TG 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test – Static. Species Pseudokirchneriella subcapitata (green alga) Exposure Period 96 hours Concentration Nominal: 2.2–35 mg/L Actual: 0.99–34 mg/L Auxiliary Solvent None Water Hardness 15 mg CaCO3/L Analytical Monitoring Gas chromatography Remarks - Method Conducted in accordance with the test guidelines above, and in compliance with GLP standards and principles. Biomass Growth EC50 NOEC EC50 NOEC mg/L at 96 h mg/L mg/L at 96 h mg/L 11 (95% CI 10-13) 2.5 21 (95% CI 19-25) 2.5 Remarks - Results All validity criteria of the test guideline were satisfied. The actual concentrations of the test item were measured at the start of the test period. Over the 96 hours test period, the test item concentrations in the test media decreased. Thus, the mean measured time-weighted exposure concentrations were calculated taking into account the