The positive controls produced satisfactory responses, thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains. The notified chemical was not mutagenic to bacteria under the conditions of the test. WIL (2013) Genotoxicity in vitro – Notified chemical OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Species/Strain Human Cell Type/Cell Line Lymphocytes/peripheral Metabolic Activation System S9 fraction from rat liver phenobarbitone/β-naphthoflavone-induced Vehicle Dimethyl sulfoxide Remarks - Method No significant deviations from the OECD guidelines. A preliminary range finding study was conducted to measure the solubility and cytotoxic effects of test substance. Metabolic Test Substance Concentration Exposure Harvest (μg/mL) Activation Period Time Absent Test 1 1*, 10*, 100, 120*, 140 and 160 3 h 24 h Test 2 3, 10, 30, 50*, 75* and 100* 24 h 24 h 3*, 10, 30*, 50, 75* and 100 48 h 48 h Present Test 1 1*, 10, 100*, 120, 140* and 160 3 h 24 h Test 2 3, 10, 30, 50*, 100*, 150* and 200 3 h 48 h *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity Precipitation Genotoxic Effect Absent Test 1 120 160 Negative ≥ ≥ Test 2 (24 h) 100 > 100 Negative ≥ Test 2 (48 h) 75 > 100 Negative ≥ Present Test 1 160 160 Negative ≥ ≥ Test 2 > 150 200 Negative ≥ Remarks - Results No statistically significant increase in the frequency of cells with chromosomal aberrations, polyploid cells or cells with endoreduplicated chromosomes was seen at any dose levels, with and without metabolic activation. The positive and negative controls produced satisfactory responses confirming the validity of the test system. The notified chemical was not clastogenic to human lymphocytes treated under the conditions of the test. in vitro WIL (2014k)
The positive controls produced satisfactory responses, thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains. The notified chemical was not mutagenic to bacteria under the conditions of the test. WIL (2013) Genotoxicity – in vitro Notified chemical OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Species/Strain Human Cell Type/Cell Line Lymphocytes/peripheral Metabolic Activation System S9 fraction from phenobarbitone/β-naphthoflavone-induced rat liver Vehicle Dimethyl sulfoxide Remarks - Method No significant deviations from the OECD guidelines. A preliminary range finding study was conducted to measure the solubility and cytotoxic effects of test substance. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 1*, 10*, 100, 120*, 140 and 160 3 h 24 h Test 2 3, 10, 30, 50*, 75* and 100* 24 h 24 h 3*, 10, 30*, 50, 75* and 100 48 h 48 h Present Test 1 1*, 10, 100*, 120, 140* and 160 3 h 24 h Test 2 3, 10, 30, 50*, 100*, 150* and 200 3 h 48 h *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity Precipitation Genotoxic Effect Absent Test 1 ≥ 120 ≥ 160 Negative Test 2 (24 h) ≥ 100 > 100 Negative Test 2 (48 h) ≥ 75 > 100 Negative Present Test 1 ≥ 160 ≥ 160 Negative Test 2 > 150 ≥ 200 Negative Remarks - Results No statistically significant increase in the frequency of cells with chromosomal aberrations, polyploid cells or cells with endoreduplicated chromosomes was seen at any dose levels, with and without metabolic activation. The positive and negative controls produced satisfactory responses confirming the validity of the test system. The notified chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. WIL (2014k)