strain TA98 in the presence of S-9 only, under the typhimurium conditions of the test. Covance Laboratories Ltd (2010) Genotoxicity in vitro – Notified Polymer (72.7%) OECD TG 487 Draft guideline for In vitro Mammalian Cell Micronucleus Test. Species/Strain Human Cell Type/Cell Line Lymphocyte cells Metabolic Activation System S-9 Aroclor 1254 Vehicle Purified water Remarks - Method The test method used by notifier is in line with the OECD test guideline. The negative control was sterile purified water. The positive controls used were mitomycin C, cyclophosphamide and vinblastine. A correction factor of 1.376 was applied to all concentrations to account for the purity value of 72.7%. Metabolic Test Substance Concentration Exposure Harvest (μg/mL) Activation Period Time Absent Test 1 10, 20*, 40*, 60, 80*, 100, 120, 140*, 160, 180, 200, 250 3 24 Test 2 5, 10*, 20, 30*, 40, 50*, 60*, 70, 80, 90, 100, 120 24 24 Present Test 1 50, 100*, 125*, 150*, 175, 200, 225, 250, 275, 300, 350, 3 24 400 *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 (>60%) (>60%) Absent Test 1 >250 Negative ≥233 ≥160 Test 2 >400 Negative ≥84 ≥60 Present Test 1 >120 Negative ≥389 ≥175 Test 2 Remarks - Results Statistically significant increases in the number of MNBN (micronucleated binucleate) cells were seen at the highest concentration tested following 3+21 hour and 24+0 hour treatments, in the absence of metabolic activation. These increases were discounted because they only occurred in one of two replicate cultures. No statistically significant increases in the number of MNBN cells were seen in other test groups The notified polymer did not induce micronuclei in cultured human peripheral blood lymphocytes treated under the conditions of the in vitro test.
typhimurium strain TA98 in the presence of S-9 only, under the conditions of the test. Covance Laboratories Ltd (2010) Genotoxicity – in vitro Notified Polymer (72.7%) OECD TG 487 Draft guideline for In vitro Mammalian Cell Micronucleus Test. Species/Strain Human Cell Type/Cell Line Lymphocyte cells Metabolic Activation System S-9 Aroclor 1254 Vehicle Purified water Remarks - Method The test method used by notifier is in line with the OECD test guideline. The negative control was sterile purified water. The positive controls used were mitomycin C, cyclophosphamide and vinblastine. A correction factor of 1.376 was applied to all concentrations to account for the purity value of 72.7%. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 10, 20*, 40*, 60, 80*, 100, 120, 140*, 160, 180, 200, 250 3 24 Test 2 5, 10*, 20, 30*, 40, 50*, 60*, 70, 80, 90, 100, 120 24 24 Present Test 1 50, 100*, 125*, 150*, 175, 200, 225, 250, 275, 300, 350, 400 3 24 *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test (>60%) Cytotoxicity in Main Test (>60%) Precipitation Genotoxic Effect Absent Test 1 ≥233 ≥160 >250 Negative Test 2 ≥84 ≥60 >400 Negative Present Test 1 ≥389 ≥175 >120 Negative Test 2 Remarks - Results Statistically significant increases in the number of MNBN (micronucleated binucleate) cells were seen at the highest concentration tested following 3+21 hour and 24+0 hour treatments, in the absence of metabolic activation. These increases were discounted because they only occurred in one of two replicate cultures. No statistically significant increases in the number of MNBN cells were seen in other test groups The notified polymer did not induce micronuclei in cultured human peripheral blood lymphocytes treated in vitro under the conditions of the test.