the validity of the test system. The notified chemical was not mutagenic to bacteria under the conditions of the test. WIL (2014d) Genotoxicity in vitro – Notified chemical OECD TG 473 Mammalian Chromosome Aberration Test. In vitro Species/Strain Human peripheral lymphocytes Cell Type/Cell Line Lymphocytes Metabolic Activation System S9 mix prepared from induced rat liver phenobarbital/β-naphthoflavone Vehicle Dimethyl sulfoxide (DMSO) Remarks - Method The test substance contains > 10% impurities and no correction was made for the purity/composition. A dose range-finding study was carried out at 5.4-512 h μg/mL (3 exposure) and 1.7-1600 (24 h or 48 h exposure). The dose selection μg/mL for the main experiments was based on the solubility and results from the preliminary study. Vehicle and positive controls (mitomycin C and cyclophosphamide) were run concurrently with the notified chemical. Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Absent Test 1 52*, 164*, 512* 3 h 24 h Test 2 50, 75*, 100*, 125*, 150, 175, 200 24 h 24 h Test 3 50*, 75*, 100*, 125, 150, 175, 200 48 h 48 h Present Test 1 52*, 164*, 512* 3 h 24 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 > 512 > 512 512 negative ≥ Test 2 125 200 negative ≥ 164 ≥ ≥ Test 3 164 100 200 negative ≥ ≥ ≥ Present Test 1 > 512 > 512 512 negative ≥ Remarks - Results In the tests, no effect of the test substance on the number of polyploidy cells and cells with endoreduplicated chromosomes were noted in the presence or absence of metabolic activation. The notified chemical was not clastogenic to human lymphocytes treated under the conditions of the test. in vitro WIL (2014e)
the validity of the test system. The notified chemical was not mutagenic to bacteria under the conditions of the test. WIL (2014d) Genotoxicity – in vitro Notified chemical OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Species/Strain Human peripheral lymphocytes Cell Type/Cell Line Lymphocytes Metabolic Activation System S9 mix prepared from phenobarbital/β-naphthoflavone induced rat liver Vehicle Dimethyl sulfoxide (DMSO) Remarks - Method The test substance contains > 10% impurities and no correction was made for the purity/composition. A dose range-finding study was carried out at 5.4-512 μg/mL (3 h exposure) and 1.7-1600 μg/mL (24 h or 48 h exposure). The dose selection for the main experiments was based on the solubility and results from the preliminary study. Vehicle and positive controls (mitomycin C and cyclophosphamide) were run concurrently with the notified chemical. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 52*, 164*, 512* 3 h 24 h Test 2 50, 75*, 100*, 125*, 150, 175, 200 24 h 24 h Test 3 50*, 75*, 100*, 125, 150, 175, 200 48 h 48 h Present Test 1 52*, 164*, 512* 3 h 24 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 > 512 > 512 ≥ 512 negative Test 2 ≥ 164 ≥ 125 ≥ 200 negative Test 3 ≥ 164 ≥ 100 ≥ 200 negative Present Test 1 > 512 > 512 ≥ 512 negative Remarks - Results In the tests, no effect of the test substance on the number of polyploidy cells and cells with endoreduplicated chromosomes were noted in the presence or absence of metabolic activation. The notified chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. WIL (2014e)
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