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EC number: 947-876-9 | CAS number: -
The test item was tested with regard to a potential mutagenic activity using the Bacterial Reverse Mutation Assay according to OECD guideline 471. The experiments were carried out using histidine-requiring auxotroph strains ofSalmonella typhimurium(Salmonella typhimurium TA98, TA100, TA1535 and TA1537), and the tryptophan-requiring auxotroph strain of Escherichia coli (Escherichia coli WP2uvrA) in the presence and absence of a post mitochondrial supernatant (S9) prepared from livers of Phenobarbital/β-naphthoflavone-induced rats (the additional complementary pre-incubation test was performed withSalmonella typhimuriumTA98, TA1535 and TA1537, in the absence of S9, only). The study included a preliminary solubility test, preliminary concentration range finding tests (informatory toxicity tests), an initial mutation test (plate incorporation test), a confirmatory mutation test (pre-incubation test) and an additional complementary pre-incubation test. Based on the results of the solubility test and the concentration range finding tests the test item was suspended/dissolved in dimethyl sulfoxide (DMSO). At the formulation of test item solutions a correction of the concentrations for the purity (96.59 %) of test item was made in the experiments. Based on the cytotoxicity and solubility results of the preliminary concentration range finding tests (informatory toxicity tests) and based on the recommendations in OECD 471 guideline, the following concentrations of the test item were prepared and investigated in the initial and confirmatory mutation tests: 5000; 1600; 500; 160; 50; 16 and 5 μg/plate. The results of the preliminary concentration range finding tests allowed the applying of the recommended maximum test concentration of 5000 μg/plate. Because of the strong inhibitory effect of the test item noticed in the confirmatory mutation test an experimental repeat (completion) with a modified concentration range was considered necessary withS. typhimurium TA98, TA1535 and TA1537 strains in the absence of exogenous metabolic activation (-S9 mix). The examined concentration levels were: 50; 16; 5; 1.6 and 0.5 μg/plate.
When evaluated by naked eye, non-interfering test item precipitate (test item particles) was noticed after about 48 hours incubation on the plates in the examined strains at the concentrations of 5000 and 1600 μg/plate in the absence and presence (±S9 mix) of exogenous metabolic activation following the plate incorporation and pre-incubation procedures. The test item did not show inhibitory, cytotoxic effects in the initial mutation test. The colony and background lawn development was not affected in any case; the obtained revertant colony number decreases (compared to the revertant colony numbers of the solvent control) remained within the biological variability range of the applied test system. However, unequivocal inhibitory effect of the test item was observed in the confirmatory mutation test and in the additional complementary pre-incubation test in the investigatedSalmonella typhimuriumstrains in the absence of exogenous metabolic activation (-S9 mix). The inhibitory effect was indicated by absent or decreased revertant colony counts (most of them below the corresponding historical control data ranges) and/or affected background lawn development: reduced or slightly reduced background lawn. In general, 16 μg/plate (noticed in S. typhimurium TA1537, in absence of exogenous metabolic activation) was considered as the lowest concentration showing cytotoxicity.
The revertant colony numbers of solvent control dimethyl sulfoxide (DMSO) plates with and without S9 mix demonstrated the characteristic mean number of spontaneous revertants that was in line with the corresponding historical control data ranges. The reference mutagen treatments (positive controls) showed the expected, biological relevant increases (more than 3-fold increase) in induced revertant colonies and the number of revertants fell in the corresponding historical control ranges, thereby meeting the criteria for the positive control in all experimental phases, in all tester strains. No biologically relevant increases were observed in the 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. The reported data of this mutagenicity assay show that under the experimental conditions applied, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. In conclusion, the test itemhas no mutagenic activity on the applied bacterium tester strains under the test conditions used in this study.
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