Mutagenicity Test: Chromosome Aberration Test Using Cultured Mammalian Cells, Japan (simplified chromosome aberration test) The test substance was examined at 1 sample per dose level. Species/Strain Chinese hamster Cell Type/Cell Line Lung fibroblasts (CHL/IU) Metabolic Activation System S9 mix (commercially prepared from rat liver, induction system not specified) Vehicle Water Remarks - Method The study was not conducted in compliance with GLP. Metabolic Activation Test Substance Concentration Exposure Period Harvest Time (μg/mL) Absent Test 1 23.1, 46.3, 92.5, 185, 370*, 740*, 6 24 hours 1480* Test 2 23.1, 46.3, 92.5, 185, 370*, 740*, 24 hours 24 hours 1480* Present Test 1 23.1, 46.3, 92.5, 185, 370*, 740*, 6 hours 24 hours 1480* *Cultures selected for metaphase analysis Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Cytotoxicity in Main Precipitation Genotoxic Effect Preliminary Test Test Absent Test 1 - > 1,480 > 1,480 Negative Test 2 - > 1,480 > 1,480 Negative Present Test 1 - > 1,480 > 1,480 Negative Remarks - Results Positive controls produced high numbers of aberrations, indicative of sensitivity of the test system. The notified chemical was not clastogenic to Chinese hamster lung treated under the conditions of the test. in vitro CERI (2013) Genotoxicity mammalian chromosome aberration test in vitro – Notified chemical (99.98% in purity) OECD TG 473 Mammalian Chromosome Aberration Test In Species/Strain Chinese hamster Cell Type/Cell Line Lung cell line (CHL) Metabolic Activation System S9 mix (commercial Aroclor-1254 induced rat liver homogenate) Vehicle Distilled water Remarks - Method No significant deviations of the protocol were noted. Concentrations of the test substance for the main tests were determined using a range-finding test. Cytotoxicity was < 50% at all concentrations tested (up to 1,500 μg/mL). Metabolic Activation Test Substance Concentration Exposure Period Harvest Time (μg/mL)
Mutagenicity Test: Chromosome Aberration Test Using Cultured Mammalian Cells, Japan (simplified chromosome aberration test) The test substance was examined at 1 sample per dose level. Species/Strain Chinese hamster Cell Type/Cell Line Lung fibroblasts (CHL/IU) Metabolic Activation System S9 mix (commercially prepared from rat liver, induction system not specified) Vehicle Water Remarks - Method The study was not conducted in compliance with GLP. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 23.1, 46.3, 92.5, 185, 370*, 740*, 1480* 6 24 hours Test 2 23.1, 46.3, 92.5, 185, 370*, 740*, 1480* 24 hours 24 hours Present Test 1 23.1, 46.3, 92.5, 185, 370*, 740*, 1480* 6 hours 24 hours *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 - > 1,480 > 1,480 Negative Test 2 - > 1,480 > 1,480 Negative Present Test 1 - > 1,480 > 1,480 Negative Remarks - Results Positive controls produced high numbers of aberrations, indicative of sensitivity of the test system. The notified chemical was not clastogenic to Chinese hamster lung treated in vitro under the conditions of the test. CERI (2013) Genotoxicity – in vitro mammalian chromosome aberration test Notified chemical (99.98% in purity) OECD TG 473 In Mammalian Chromosome Aberration Test Species/Strain Chinese hamster Cell Type/Cell Line Lung cell line (CHL) Metabolic Activation System S9 mix (commercial Aroclor-1254 induced rat liver homogenate) Vehicle Distilled water Remarks - Method No significant deviations of the protocol were noted. Concentrations of the test substance for the main tests were determined using a range-finding test. Cytotoxicity was < 50% at all concentrations tested (up to 1,500 μg/mL). Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time
STD1524-FR-Final.DOCX