Notified chemical (~59% purity) OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Species/Strain Chinese hamster Cell Type/Cell Line V79 cells Metabolic Activation System S9 mix derived from Phenobarbital induced Wistar rat liver. Vehicle Deionised water Remarks - Method No significant protocol deviations Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Absent Test 1 75*, 150*, 300*, 600, 900, 1200 4 hr 18 hr Test 2 25, 50, 100*, 150, 200*, 250* 18 hr 18 hr Test 3 100, 150*, 200*, 250 28 hr 28 hr Present Test 1 12.5, 25, 50*, 100*, 150*, 200 4 hr 18 hr Test 2 12.5, 25, 50*, 100*, 150, 200* 4 hr 28 hr *Cultures selected for metaphase analysis. Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ~300 >1200 Negative Test 2 >250 >250 Negative Test 3 100-150 >250 Negative Present Test 1 100-150 >200 Positive Test 2 150-200 >200 Positive Remarks - Results In the presence of S9 mix the aberration rates (Test 1: 8.0% and 7.5%, respectively; Test 2: 19.5%) were biologically relevant and statistically significant increases were observed after treatment with 100 and 150 (Test 1) and with 200 (Test 2) compared to the solvent μg/mL μg/mL control (Test 1: 1%; Test 2: 1.5%). The notified chemical was clastogenic to Chinese hamster V79 cells treated in vitro under the conditions of the test. RCC Ltd Genotoxicity in vivo – Notified chemical (~59% purity) OECD TG 474 Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/NMRI Route of Administration Oral gavage. – Vehicle Deionised water Remarks Method No significant protocol deviations. – Dose Number and Sex Sacrifice Time mg/kg bw of Animals hours 0 6/sex 24 500 6/sex 24
Notified chemical (~59% purity) OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Species/Strain Chinese hamster Cell Type/Cell Line V79 cells Metabolic Activation System S9 mix derived from Phenobarbital induced Wistar rat liver. Vehicle Deionised water Remarks - Method No significant protocol deviations Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 75*, 150*, 300*, 600, 900, 1200 4 hr 18 hr Test 2 25, 50, 100*, 150, 200*, 250* 18 hr 18 hr Test 3 100, 150*, 200*, 250 28 hr 28 hr Present Test 1 12.5, 25, 50*, 100*, 150*, 200 4 hr 18 hr Test 2 12.5, 25, 50*, 100*, 150, 200* 4 hr 28 hr *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ~300 >1200 Negative Test 2 >250 >250 Negative Test 3 100-150 >250 Negative Present Test 1 100-150 >200 Positive Test 2 150-200 >200 Positive Remarks - Results In the presence of S9 mix the aberration rates (Test 1: 8.0% and 7.5%, respectively; Test 2: 19.5%) were biologically relevant and statistically significant increases were observed after treatment with 100 and 150 μg/mL (Test 1) and with 200 μg/mL (Test 2) compared to the solvent control (Test 1: 1%; Test 2: 1.5%). The notified chemical was clastogenic to Chinese hamster V79 cells treated in vitro under the conditions of the test. RCC Ltd Genotoxicity – in vivo Notified chemical (~59% purity) OECD TG 474 Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/NMRI Route of Administration Oral – gavage. Vehicle Deionised water Remarks – Method No significant protocol deviations. Dose mg/kg bw Number and Sex of Animals Sacrifice Time hours 0 6/sex 24 500 6/sex 24
STD1271-FR.docx