The analogue chemical was not mutagenic to bacteria under the conditions of the test. Covance Laboratories Inc (1998e) bacteria – Analogue D OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 97/69/EC Mutagenicity Reverse Mutation Test using – Bacteria. Plate incorporation procedure Species/Strain TA1535, TA1537, TA98, TA100 S. typhimurium: WP2uvrA E. coli: Metabolic Activation System Aroclor 1254 induced rat liver S9 fraction Concentration Range in a) With metabolic activation: 100, 250, 500, 1000, 5000, µg/plate Main Test b) Without metabolic activation: 100, 250, 500, 1000, 5000, 10000 µg/plate Vehicle None Remarks - Method No significant protocol deviations Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Absent Test 1 None None 1000μg/plate None ≥ Test 2 None 1000μg/plate None ≥ Present Test 1 None None 1000μg/plate None ≥ Test 2 None 1000μg/plate None ≥ Remarks - Results Positive control substances had the appropriate response. Negative controls were within historical limits. The analogous chemical was not mutagenic to bacteria under the conditions of the test. CHV (1997) 7.12. Genotoxicity in vitro – Analogue A OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Cell Type/Cell Line Human lymphocytes Metabolic Activation System Aroclor 1254 induced rat liver S9fraction. Vehicle DMSO Remarks - Method No significant protocol deviations. Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Absent Test 1 34.7, 49.5, 70.7, 101, 144*, 205*, 293*, 419, 598, 854, 3 h 22 h 1220, 1740, 2480, 3540, 5050 μg/mL Test 2 12.5, 25, 50, 100, 150*, 200*, 250*, 300, 350, 400 19.3 h 22 h μg/mL Test 3 12.5, 25*, 50*, 100*, 150, 200, 250, 300, 350, 400 43.3 h 46 h μg/mL Present
The analogue chemical was not mutagenic to bacteria under the conditions of the test. Covance Laboratories Inc (1998e) – bacteria Analogue D OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 97/69/EC Mutagenicity – Reverse Mutation Test using Bacteria. Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100 E. coli: WP2uvrA Metabolic Activation System Aroclor 1254 induced rat liver S9 fraction Concentration Range in Main Test a) With metabolic activation: 100, 250, 500, 1000, 5000, µg/plate b) Without metabolic activation: 100, 250, 500, 1000, 5000, 10000 µg/plate Vehicle None Remarks - Method No significant protocol deviations Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 None None ≥ 1000μg/plate None Test 2 None ≥ 1000μg/plate None Present Test 1 None None ≥ 1000μg/plate None Test 2 None ≥ 1000μg/plate None Remarks - Results Positive control substances had the appropriate response. Negative controls were within historical limits. The analogous chemical was not mutagenic to bacteria under the conditions of the test. CHV (1997) 7.12. Genotoxicity – in vitro Analogue A OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Cell Type/Cell Line Human lymphocytes Metabolic Activation System Aroclor 1254 induced rat liver S9fraction. Vehicle DMSO Remarks - Method No significant protocol deviations. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 34.7, 49.5, 70.7, 101, 144*, 205*, 293*, 419, 598, 854, 1220, 1740, 2480, 3540, 5050 μg/mL 3 h 22 h Test 2 12.5, 25, 50, 100, 150*, 200*, 250*, 300, 350, 400 μg/mL 19.3 h 22 h Test 3 12.5, 25*, 50*, 100*, 150, 200, 250, 300, 350, 400 μg/mL 43.3 h 46 h Present
STD1201FR.docx