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EC number: 235-834-6 | CAS number: 13001-38-2
The potential of test substance to induce gene mutations was investigated in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate.
In experiment II, the colony counts of the negative and solvent controls of strain TA 1535 were far beyond the historical range in the presence and absence of metabolic activation. Therefore, the results were dismissed and an additional experiment with strain TA 1535 was performed. The results of this additional experiment are included in experiment II.
The test item was tested at the following concentrations: 33; 100; 333; 1000; 2500; and 5000 µg/plate The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments.
Appropriate reference mutagens were used as positive controls.
No toxic effects, evident as a reduction in the number of reventants, occurred in the test groups with and without metabolic activation. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with test substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Positive controls showed a distinct increase of induced revertant colonies.
Overall, test substance was considered as non mutagenic in the AMES assay.
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