Remarks - Method The positive controls used in the study were mitocycin C (without metabolic activation) and cyclophosphamide (with metabolic activation). Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Absent Test 1 10, 25, 50*, 125*, 250*, 500, 750, 1000 4 h 20 h Test 2 10, 25, 50*, 125*, 200, 300*, 400, 500 20 h 20 h Present Test 1 10, 25, 50, 125*, 250*, 500*, 750, 1000 4 h 20 h *Cultures selected for metaphase analysis. Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Absent Test 1 1500 250 > 1000 Negative ≥ ≥ Test 2 500 300 > 500 Negative ≥ ≥ Present Test 1 1500 500 > 1000 Negative ≥ ≥ Remarks - Results No significant increases in chromosomal aberrant aberrations were observed in any treatment group at any dose level. The positive controls caused statistically significant increases in the proportion of aberrant cells, demonstrating the sensitivity of the test system and the efficacy of the S9 mix. The notified polymer was not clastogenic to human lymphocytes treated under the conditions of the test. in vitro BioReliance (2012) Appendix C: Environmental Fate and Ecotoxicological Investigations Ready biodegradability Notified polymer OECD TG 301 B Ready Biodegradability: CO2 Evolution Test. Inoculum Domestic sewage sludge Exposure Period 28 days Auxiliary Solvent None Analytical Monitoring Carbon analysis, total inorganic carbon (TIC) analysis Remarks - Method The method was conducted according to test guidelines using good laboratory practice (GLP) with no significant deviations. The test was conducted on the product containing the notified polymer at ~60% concentration. Test substance Dextrose Day % Degradation Day % Degradation 7 34.85 7 73.51
Remarks - Method The positive controls used in the study were mitocycin C (without metabolic activation) and cyclophosphamide (with metabolic activation). Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 10, 25, 50*, 125*, 250*, 500, 750, 1000 4 h 20 h Test 2 10, 25, 50*, 125*, 200, 300*, 400, 500 20 h 20 h Present Test 1 10, 25, 50, 125*, 250*, 500*, 750, 1000 4 h 20 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 Test 1 ≥ 1500 ≥ 250 > 1000 Negative Test 2 ≥ 500 ≥ 300 > 500 Negative Present Test 1 ≥ 1500 ≥ 500 > 1000 Negative Remarks - Results No significant increases in chromosomal aberrant aberrations were observed in any treatment group at any dose level. The positive controls caused statistically significant increases in the proportion of aberrant cells, demonstrating the sensitivity of the test system and the efficacy of the S9 mix. The notified polymer was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. BioReliance (2012) Appendix C: Environmental Fate and Ecotoxicological Investigations Ready biodegradability Notified polymer OECD TG 301 B Ready Biodegradability: CO2 Evolution Test. Inoculum Domestic sewage sludge Exposure Period 28 days Auxiliary Solvent None Analytical Monitoring Carbon analysis, total inorganic carbon (TIC) analysis Remarks - Method The method was conducted according to test guidelines using good laboratory practice (GLP) with no significant deviations. The test was conducted on the product containing the notified polymer at ~60% concentration. Test substance Dextrose Day % Degradation Day % Degradation 7 34.85 7 73.51