No cytotoxicity was observed in Experiment 1. Comment: In both experiments the test substance did not cause any significant increases in the incidence of mutant colonies in the presence or absence of metabolic activation from that of the negative control. Positive controls used in the test caused marked increases in the incidence of mutant colonies and the activity of the S9 fraction was to be satisfactory. The notified chemical did not induce gene mutations in CHO Result: cells. 9.4.3 Chromosomal Aberration Assay (Health and Environmental Services 1989a) Rat lymphocytes Cells: Liver S9 fraction from Sprague-Dawley rats pre treated with Aroclor Auxillary Metabolic activation 1254 at 500 mg/kg. system: Each concentration was tested in duplicate, in two independent Dosing schedule: experiments for a treatment time of 4 hours in the presence or absence of metabolic activation at test concentrations of 0, 166.7, 500*, 1666.7*, 5000* g/mL. Appropriate clastogenic control substances were used. *cultures selected for metaphase analysis. OECD TG 473; EC Method B10. Test method: Cytotoxicity was not observed at any concentration. Comment: The test substance did not cause any significant increases in the incidence of cells with chromosomal aberrations, polyploidy or endoreplication, at the concentrations analysed in the presence or absence of metabolic activation. Positive controls used in the test caused marked increases in the incidence of aberrant cells and the activity of the S9 fraction was found to be satisfactory. The notified chemical was not considered clastogenic the Result: conditions of the test. 9.4.4 Micronucleus in the Bone Marrow Cells of the Mouse (Health and Environmental Services 1992) (ICR) BR Species/strain: 5/sex/test group Number and sex of animals: Test substance: 0, 200, 666, 2000 mg/kg. Study design: Positive control, cyclophosphamide (CP): 120 mg/kg.
Comment: No cytotoxicity was observed in Experiment 1. In both experiments the test substance did not cause any significant increases in the incidence of mutant colonies in the presence or absence of metabolic activation from that of the negative control. Positive controls used in the test caused marked increases in the incidence of mutant colonies and the activity of the S9 fraction was to be satisfactory. Result: The notified chemical did not induce gene mutations in CHO cells. 9.4.3 Chromosomal Aberration Assay (Health and Environmental Services 1989a) Cells: Rat lymphocytes Auxillary Metabolic activation system: Liver S9 fraction from Sprague-Dawley rats pre treated with Aroclor 1254 at 500 mg/kg. Dosing schedule: Each concentration was tested in duplicate, in two independent experiments for a treatment time of 4 hours in the presence or absence of metabolic activation at test concentrations of 0, 166.7, 500*, 1666.7*, 5000* g/mL. Appropriate clastogenic control substances were used. *cultures selected for metaphase analysis. Test method: OECD TG 473; EC Method B10. Comment: Cytotoxicity was not observed at any concentration. The test substance did not cause any significant increases in the incidence of cells with chromosomal aberrations, polyploidy or endoreplication, at the concentrations analysed in the presence or absence of metabolic activation. Positive controls used in the test caused marked increases in the incidence of aberrant cells and the activity of the S9 fraction was found to be satisfactory. Result: The notified chemical was not considered clastogenic the conditions of the test. 9.4.4 Micronucleus in the Bone Marrow Cells of the Mouse (Health and Environmental Services 1992) Species/strain: (ICR) BR Number and sex of animals: 5/sex/test group Study design: Test substance: 0, 200, 666, 2000 mg/kg. Positive control, cyclophosphamide (CP): 120 mg/kg.
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