EBS (1996e) 7.11. Genotoxicity in – Analogous chemical. OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Cell Type/Cell Line CHO cells (WBL) Metabolic Activation System Aroclor 1254 rat liver induced S9 fraction. Vehicle tetrahydrofuran Remarks - Method Maximum concentrations were determined based on solubility. Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Absent Test 1 2, 4, 8, 16*, 32* ,64* 16 hours 36 hours μg/mL Test 2 2, 4, 8, 16*, 32*, 64* 16 hours 40 hours μg/mL Present Test 1 2, 4, 8, 16*, 32*, 64* 16 hours 36 hours μg/mL Test 2 2, 4, 8, 16*, 32*, 64* 16 40 hours μg/mL *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 None. None. >32 None. μg/mL Test 2 None. None. >16 None. μg/mL Present Test 1 None. None. >32 None. μg/mL Test 2 None. None. 64 None. μg/mL Remarks - Results DMBA and MNNG were used as positive controls and induced distinct increases in the proportion of cells with structural chromosomal aberrations. The analogous chemical was not clastogenic to CHO cells treated in vitro under the conditions of the test. EBS (1996f) 7.12. Genotoxicity in vivo – Analogous chemical. OECD TG 475 Mammalian Bone Marrow Chromosome Aberration Test. Species/Strain Mouse/CD-1 Route of Administration Oral gavage – Vehicle Peanut oil Remarks - Method No significant protocol deviations. Group Number and Sex Dose Sacrifice Time of Animals mg/kg bw hours
EBS (1996e) 7.11. Genotoxicity – in Analogous chemical. OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Cell Type/Cell Line CHO cells (WBL) Metabolic Activation System Aroclor 1254 rat liver induced S9 fraction. Vehicle tetrahydrofuran Remarks - Method Maximum concentrations were determined based on solubility. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 2, 4, 8, 16*, 32* ,64* μg/mL 16 hours 36 hours Test 2 2, 4, 8, 16*, 32*, 64* μg/mL 16 hours 40 hours Present Test 1 2, 4, 8, 16*, 32*, 64* μg/mL 16 hours 36 hours Test 2 2, 4, 8, 16*, 32*, 64* μg/mL 16 40 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 None. None. >32 μg/mL None. Test 2 None. None. >16 μg/mL None. Present Test 1 None. None. >32 μg/mL None. Test 2 None. None. 64 μg/mL None. Remarks - Results DMBA and MNNG were used as positive controls and induced distinct increases in the proportion of cells with structural chromosomal aberrations. The analogous chemical was not clastogenic to CHO cells treated in vitro under the conditions of the test. EBS (1996f) 7.12. Genotoxicity – in vivo Analogous chemical. OECD TG 475 Mammalian Bone Marrow Chromosome Aberration Test. Species/Strain Mouse/CD-1 Route of Administration Oral – gavage Vehicle Peanut oil Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time hours
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