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EC number: 452-570-9 | CAS number: -
This study according to OECD Guideline 471 was performed to investigate the potential of the test item to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II and III) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102.
The experiments were performed with and without liver microsomal activation. In experiment II, no unambiguous positive response was reached in strain TA 100 with S9 mix (factor 2.1) and in strain TA 102 with (factor 2.2) and without S9 mix (factor 2.4) Therefore, these result were dismissed and an additional experiment was performed with strains TA 100 with S9 mix and TA 102 with and without S9 mix. The results of this additional experiment are reported as experiment II. Each concentration, including the controls, was tested in triplicate. The test article was tested at the following concentrations:
33, 100, 333, 1000, 2500, and 5000 µg/plate.
No relevant toxic effects, evident as a reduction in the number of revenants, occurred in the test groups with and without metabolic activation.
The plates incubated with the test article showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item 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.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, the test item is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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