Positive control: (without S9-mix) 2-nitrofluorene for TA98 and TA1538; sodium azide for TA100 and TA1535; 9-aminoacridine for TA1537; and methyl methanesulfonate for strains. E. coli Positive control: (with S9-mix) Sterigmatocystin for WP2 (pKM101); and 2-aminoanthracene for the remaining strains. OECD TG 471 Test method: Test article was soluble at 100 mg/mL, the maximum Comment: concentration tested. Toxicity was observed at 5 000 and 1800 g per plate, with and without S9-mix, respectively when using preincubation method. No appreciable toxicity was observed in the tests using plate incorporation method. were no significant increases in revertant colony numbers at any concentration, in the presence or absence of metabolic activation. Concurrent positive controls used in the tests induced marked increases in the frequency of revertant colonies and the activity of the S9 fraction was found to be satisfactory. Historic data were included to support the study findings. The notified chemical was non mutagenic the Result: conditions of the test. 9.3.2 Clonal Transformation Assay in Syrian Golden Hamster Embryo (SHE) Cells (Custer, 1999) Syrian golden hamster embryo (SHE) cells Cells: Each experiment consisted of 40 dishes per treatment group Dosing schedule: including at least one vehicle control and one positive control. Experiment Test concentration (g/mL) Controls treatment time = 24 hours 0, 15*, 35*, 40, 50*, 150*, 250*, 350 Positive: and 625 g/mL. Benzo(a)pyrene in DMSO Vehicle: DMEM culture medium treatment time = 7 days 0, 5*, 20*, 35*, (42*), 50*, (60*), 65, Positive: 80 and 100 g/mL. Benzo(a)pyrene in DMSO Vehicle: DMEM culture medium
Positive control: (without S9-mix) 2-nitrofluorene for TA98 and TA1538; sodium azide for TA100 and TA1535; 9-aminoacridine for TA1537; and methyl methanesulfonate for E. coli strains. Positive control: (with S9-mix) Sterigmatocystin for WP2 (pKM101); and 2-aminoanthracene for the remaining strains. Test method: OECD TG 471 Comment: Test article was soluble at 100 mg/mL, the maximum concentration tested. Toxicity was observed at 5 000 and 1800 g per plate, with and without S9-mix, respectively when using preincubation method. No appreciable toxicity was observed in the tests using plate incorporation method. were no significant increases in revertant colony numbers at any concentration, in the presence or absence of metabolic activation. Concurrent positive controls used in the tests induced marked increases in the frequency of revertant colonies and the activity of the S9 fraction was found to be satisfactory. Historic data were included to support the study findings. Result: The notified chemical was non mutagenic the conditions of the test. 9.3.2 Clonal Transformation Assay in Syrian Golden Hamster Embryo (SHE) Cells (Custer, 1999) Cells: Syrian golden hamster embryo (SHE) cells Dosing schedule: Each experiment consisted of 40 dishes per treatment group including at least one vehicle control and one positive control. Experiment Test concentration (g/mL) Controls treatment time = 24 hours 0, 15*, 35*, 40, 50*, 150*, 250*, 350 and 625 g/mL. Positive: Benzo(a)pyrene in DMSO Vehicle: DMEM culture medium treatment time = 7 days 0, 5*, 20*, 35*, (42*), 50*, (60*), 65, 80 and 100 g/mL. Vehicle: DMEM culture medium Positive: Benzo(a)pyrene in DMSO
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