Present Test 1 5, 10*, 20*, 30*, 40, 60 4 h 18 h Test 2 3.1, 6.3, 12.5*, 25*, 50*, 100 4 h 28 h *Cultures selected for metaphase analysis. Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect PreliminaryTest Main Test Absent Test 1 23.4 25 > 12.5 not observed ≥ Test 2 10 > 25 not observed ≥ Present Test 1 46.9 > 30 60 not observed Test 2 50 > 12.5 slight effect at 12.5 ≥ Remarks - Results The aberration rates of treated cells exclusive of gaps (0.5 3%) were – close to those of the solvent controls (0 2.0%) and within the range of – historical control data (0 4.0%). One statistically significant response – (2.5% aberrant cells) was seen in one dose and condition: 12.5g/mL in experiment 2, 4 h/28 h only and is not considered biologically significant as the response was not dose related and aberration rates were within historical control data. Positive controls showed distinct increases in aberrant cells. The notified chemical was not clastogenic to Chinese Hamster V79 cells treated in vitro under the conditions of the test. RCC (2002s) 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. biodegradability Notified chemical OECD TG 301 B Ready Biodegradability: CO2 Evolution Test. Inoculum Aerobic activated sludge. Exposure Period 28 days. Auxiliary Solvent None. Analytical Monitoring Inorganic Carbon analysis a Shimadzu TOC-500 Analyzer Remarks - Method Inoculum was aerated overnight in culture medium prior to the addition of test materials. Samples were collected from the first CO2 absorber vessel on Days 2, 5, 7, 9, 12, 14, 19, 23, 27, 28 and 29. On day 28 test vessels were treated with 1 mL of concentrated hydrochloric acid to drive of any inorganic carbonates formed. Test substance Sodium Benzoate Day % degradation Day % degradation 28 0 28 78.4
Present Test 1 5, 10*, 20*, 30*, 40, 60 4 h 18 h Test 2 3.1, 6.3, 12.5*, 25*, 50*, 100 4 h 28 h *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in PreliminaryTest Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 23.4 ≥ 25 > 12.5 not observed Test 2 ≥ 10 > 25 not observed Present Test 1 46.9 > 30 60 not observed Test 2 ≥ 50 > 12.5 slight effect at 12.5 Remarks - Results The aberration rates of treated cells exclusive of gaps (0.5 – 3%) were close to those of the solvent controls (0 – 2.0%) and within the range of historical control data (0 – 4.0%). One statistically significant response (2.5% aberrant cells) was seen in one dose and condition: 12.5g/mL in experiment 2, 4 h/28 h only and is not considered biologically significant as the response was not dose related and aberration rates were within historical control data. Positive controls showed distinct increases in aberrant cells. The notified chemical was not clastogenic to Chinese Hamster V79 cells treated in vitro under the conditions of the test. RCC (2002s) 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. biodegradability Notified chemical OECD TG 301 B Ready Biodegradability: CO2 Evolution Test. Inoculum Aerobic activated sludge. Exposure Period 28 days. Auxiliary Solvent None. Analytical Monitoring Inorganic Carbon analysis a Shimadzu TOC-500 Analyzer Remarks - Method Inoculum was aerated overnight in culture medium prior to the addition of test materials. Samples were collected from the first CO2 absorber vessel on Days 2, 5, 7, 9, 12, 14, 19, 23, 27, 28 and 29. On day 28 test vessels were treated with 1 mL of concentrated hydrochloric acid to drive of any inorganic carbonates formed. Test substance Sodium Benzoate Day % degradation Day % degradation 28 0 28 78.4
STD-1053-FR-final.docx