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EC number: 942-655-3 | CAS number: 1802727-84-9
The test item was investigated for its genotoxic potential in a bacterial reverse mutation assay according to GLP and OECD 471. The test item was dissolved in ultrapure water (ASTM Type 1). In the Initial and Confirmatory Mutation Tests the following concentrations were examined: ±S9 Mix: 5000, 1600, 500, 160, 50 and 16 μg/plate. In the Initial and Confirmatory Mutation Tests Salmonella typhimurium TA98, TA1537, TA1535 and TA100 strains and Escherichia coli WP2 uvrA were investigated. For the analysis of the test item concentrations, representative samples from the stock solutions (with a concentration of 100 mg/mL) before each main experiment and vehicle control were taken and analysed. Test item concentrations in the samples were 93 % and 99 % on the analytical occasions in comparison to the nominal values. The analytical control of the test item content was performed with a previously validated analytical method by the Analytical Laboratory of TOXI-COOP ZRT. The test item concentration in the samples was determined by a HPLC method with MS detection. Five bacterial strains were used to investigate the mutagenic potential of SIKA Amine PB (SIKA Amin PB) in two independent experiments, in a plate incorporation test (experiment I, Initial Mutation Test) and in a pre-incubation test (experiment II, Confirmatory Mutation Test). Each assay was conducted with and without metabolic activation (±S9 Mix). The concentrations, including the controls, were tested in triplicate. In the performed experiments positive and negative (vehicle) controls were run concurrently.
In the performed experiments all of the validity criteria, regarding the investigated strains, negative (vehicle) and positive controls, S9 activity and number of investigated analyzable concentration levels were fulfilled. No biological relevant increases were observed in revertant colony numbers of any of the five test strains following treatment with the test item at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments. In the Initial Mutation Test in Salmonella typhimurium TA100, the obtained revertant colony number increases were above the corresponding historical control data range and remained just below the relevant genotoxicological threshold for being positive at 5000 µg/plate, without exogenous metabolic activation ( S9 Mix). However, the revertant colony number increases at this treatment were considered rather as unique, and were not evaluated as biological relevant.
In any other cases, in both independently performed main experiments, the observed sporadic increases in revertant colony numbers compared to the vehicle control values remained within the actual historical control data ranges. There was no tendency of higher mutation rates with increasing concentrations beyond the generally acknowledged border of biological relevance in the performed experiments.
In the Confirmatory Mutation Test (using pre-incubation method) inhibitory effect of the test item (decreased number of revertant colony numbers and affected background lawn development) was observed in all examined Salmonella typhimurium strains at the highest examined concentration of 5000 µg/plate in the absence and presence of exogenous metabolic activation (±S9 Mix).
No precipitation of the test item was observed on the plates in the examined bacterial strains at any examined concentration level (±S9 Mix) throughout the study.
The reported data of this mutagenicity assay show, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the tester strains used. Therefore, the test item is considered non-mutagenic in this bacterial reverse mutation assay.
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