Genotoxicity in vitro – Notified chemical OECD TG 473 Mammalian Chromosome Aberration Test. In vitro EC Directive 440/2008 B.10 Mutagenicity - Mammalian In vitro Chromosome Aberration Test. EPA OPPTS 870.5375- Mammalian Chromosome Aberration In Vitro Test, EPA 712-C-98-223, 1998 Cell Type/Cell Line Chinese Hamster V79 cells Metabolic Activation System S9 microsomal fraction from rat β-naphthoflavone/phenobarbital-induced liver Vehicle Cell culture medium Remarks - Method No significant protocol deviation Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Absent Test 1 125, 250, 500, 1000*, 2500*, 5000* 4 h 20 h Test 2 31.3, 62.5, 125, 250*, 500*, 1000*, 2500, 5000 20 h 20 h Present Test 1 125, 250, 500, 1000*, 2500*, 5000* 4 h 20 h Test 2 500, 1000, 2000, 3000*, 4000*, 5000* 4 h 20 h *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 5000 > 5000 > 1000 Negative ≥ Test 2 1000 > 250 Negative ≥ Present Test 1 > 5000 > 5000 > 1000 Negative Test 2 > 5000 > 3000 Negative Remarks - Results There were no statistically significant increases in the frequency of cells with chromosomal aberrations in either test, with or without metabolic activation. The negative controls were within the historical range and the positive controls demonstrated the sensitivity of the test. The notified chemical was not clastogenic to Chinese Hamster V79 cells treated under the conditions of the test. in vitro Confidential
Genotoxicity – in vitro Notified chemical OECD TG 473 In vitro Mammalian Chromosome Aberration Test. EC Directive 440/2008 B.10 Mutagenicity - In vitro Mammalian Chromosome Aberration Test. EPA OPPTS 870.5375- In Vitro Mammalian Chromosome Aberration Test, EPA 712-C-98-223, 1998 Cell Type/Cell Line Chinese Hamster V79 cells Metabolic Activation System S9 microsomal fraction from β-naphthoflavone/phenobarbital-induced rat liver Vehicle Cell culture medium Remarks - Method No significant protocol deviation Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 125, 250, 500, 1000*, 2500*, 5000* 4 h 20 h Test 2 31.3, 62.5, 125, 250*, 500*, 1000*, 2500, 5000 20 h 20 h Present Test 1 125, 250, 500, 1000*, 2500*, 5000* 4 h 20 h Test 2 500, 1000, 2000, 3000*, 4000*, 5000* 4 h 20 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 ≥ 5000 > 5000 > 1000 Negative Test 2 ≥ 1000 > 250 Negative Present Test 1 > 5000 > 5000 > 1000 Negative Test 2 > 5000 > 3000 Negative Remarks - Results There were no statistically significant increases in the frequency of cells with chromosomal aberrations in either test, with or without metabolic activation. The negative controls were within the historical range and the positive controls demonstrated the sensitivity of the test. The notified chemical was not clastogenic to Chinese Hamster V79 cells treated in vitro under the conditions of the test. Confidential
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