The notified chemical was not mutagenic to under the S. typhimurium conditions of the test. RCC (2001v) 7.9. Genotoxicity in vitro – Notified chemical OECD TG 473 In Mammalian Chromosome Aberration Test. EC Directive 2000/32/EC B.10 Mutagenicity - In vitro Mammalian Chromosome Aberration Test. Cell Type/Cell Line Chinese Hamster lung fibroblast Cell line V79 Metabolic Activation System Phenobarbital and induced rat liver S9 fraction β–Naphthoflavone Vehicle Minimal Essential Medium Remarks - Method No significant protocol deviations. Statement of GLP included. Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Absent Test 1 78.1, 156.3, 312.5, 625*, 1250*, 2500* 4 18 Test 2 156.3, 312.5, 625*, 1250*, 2500* 18 18 Test 3 625, 1250, 1875, 2500* 28 28 Present Test 1 78.1, 156.3, 312.5, 625*, 1250*, 2500* 4 18 Test 2 148.4, 297, 594*, 1188*, 1875, 2375* 4 28 *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 >2500 >2500 >2500 Negative Test 2 >2500 >2500 >2500 Negative Test 3 >2500 >2500 >2500 Negative Present Test 1 >2500 >2500 >2500 Negative Test 2 >2375 >2375 >2375 Negative Remarks - Results Cytotoxicity was not observed at any test concentration. No statistically or biologically significant increases in the percentage of aberrant cells above the vehicle control levels, were recorded for any cultures treated with the notified chemical in either the presence or absence of metabolic activation. Positive controls confirmed the sensitivity of the test system. The notified chemical was not clastogenic to Chinese Hamster lung fibroblast Cell line V79 treated in vitro under the conditions of the test. RCC (2001w)
The notified chemical was not mutagenic to S. typhimurium under the conditions of the test. RCC (2001v) 7.9. Genotoxicity – in vitro Notified chemical OECD TG 473 In Mammalian Chromosome Aberration Test. EC Directive 2000/32/EC B.10 Mutagenicity - In vitro Mammalian Chromosome Aberration Test. Cell Type/Cell Line Chinese Hamster lung fibroblast Cell line V79 Metabolic Activation System Phenobarbital and β–Naphthoflavone induced rat liver S9 fraction Vehicle Minimal Essential Medium Remarks - Method No significant protocol deviations. Statement of GLP included. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 78.1, 156.3, 312.5, 625*, 1250*, 2500* 4 18 Test 2 156.3, 312.5, 625*, 1250*, 2500* 18 18 Test 3 625, 1250, 1875, 2500* 28 28 Present Test 1 78.1, 156.3, 312.5, 625*, 1250*, 2500* 4 18 Test 2 148.4, 297, 594*, 1188*, 1875, 2375* 4 28 *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 >2500 >2500 >2500 Negative Test 2 >2500 >2500 >2500 Negative Test 3 >2500 >2500 >2500 Negative Present Test 1 >2500 >2500 >2500 Negative Test 2 >2375 >2375 >2375 Negative Remarks - Results Cytotoxicity was not observed at any test concentration. No statistically or biologically significant increases in the percentage of aberrant cells above the vehicle control levels, were recorded for any cultures treated with the notified chemical in either the presence or absence of metabolic activation. Positive controls confirmed the sensitivity of the test system. The notified chemical was not clastogenic to Chinese Hamster lung fibroblast Cell line V79 treated in vitro under the conditions of the test. RCC (2001w)