+S9 1 6 treatment: Positive: CPH. 0, 20, 39, 78, 156, 313, 625, 1250, 2 500 and 5 000. Negative: DMSO. 2 6 hours treatment (24 hour harvest): Positive: CPH. 0, 39, 78, 625, 1 250 and 2 500. Negative: DMSO. 6 treatment (48 hour harvest): 0, 39, 78, 625, 1 250 and 2 500. - cultures selected for metaphase analysis DMSO: Dimethyl sulphoxide CPH: cyclophosphamide OECD TG 473 Test method: Precipitation increased gradually from 78 g/mL. Comment: Cytotoxicity was observed at 156 and 625 g/mL and above with and without S9 mix, respectively in the first test, and at 625 and 156 g/mL and above with and without S9 mix, respectively in the second test. The test substance did not induce any significant or increases in the frequency of cells with aberrations in either experiment. All positive and negative controls responded appropriately. The notified chemical was considered to be non-clastogenic Result: under the conditions of the study. 9.3.3 Micronucleus Assay in the Bone Marrow Cells of the Mouse (Watson & Innes, 2000) Mice/CD-1 Species/strain: Test group: 10/sex, Number and sex of animals: Vehicle control 5/sex, Positive control group: 5 males. Dosing: 2 000 mg/kg at 0 and 24 hours. Sampling: 48 hours. Vehicle: maize oil. Positive control: CPH. Oral (gavage). Method of administration: OECD TG 474 Test method:
+S9 1 6 treatment: 0, 20, 39, 78, 156, 313, 625, 1250, 2 500 and 5 000. Positive: CPH. Negative: DMSO. 2 6 hours treatment (24 hour harvest): 0, 39, 78, 625, 1 250 and 2 500. 6 treatment (48 hour harvest): 0, 39, 78, 625, 1 250 and 2 500. Positive: CPH. Negative: DMSO. - cultures selected for metaphase analysis DMSO: Dimethyl sulphoxide CPH: cyclophosphamide Test method: OECD TG 473 Comment: Precipitation increased gradually from 78 g/mL. Cytotoxicity was observed at 156 and 625 g/mL and above with and without S9 mix, respectively in the first test, and at 625 and 156 g/mL and above with and without S9 mix, respectively in the second test. The test substance did not induce any significant or increases in the frequency of cells with aberrations in either experiment. All positive and negative controls responded appropriately. Result: The notified chemical was considered to be non-clastogenic under the conditions of the study. 9.3.3 Micronucleus Assay in the Bone Marrow Cells of the Mouse (Watson & Innes, 2000) Species/strain: Mice/CD-1 Number and sex of animals: Test group: 10/sex, Vehicle control 5/sex, Positive control group: 5 males. Dosing: 2 000 mg/kg at 0 and 24 hours. Sampling: 48 hours. Vehicle: maize oil. Positive control: CPH. Method of administration: Oral (gavage). Test method: OECD TG 474
NA869FR.docx