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EC number: 245-629-3 | CAS number: 23386-52-9
The test item Butanedioic acid, sulfo, 1,4-bis(1,3-dimethylbutyl) ester, sodium salt (80% active ingredient), dissolved in deionised water, was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro in two independent experiments up to 5000 µg/mL(approx. 10 mM of the active ingredient). In each experimental group two parallel cultures were set up. Per culture 100 metaphase plates were scored for structural chromosome aberrations and 500 cells were scored for polyploidy. Toxic effects indicated by reduced cell numbers and/or mitotic indices of about and below 50% of control were observed in all experimental parts. However, in experiment I in the absence and the presence of S9 mix concentrations showing clear cytotoxicity were not evaluable for cytogenetic damage. In both independent experiments, no biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. The observed statistical significance's and dose-dependency are regarded as being biologically irrelevant. No increase in the frequencies of polyploid metaphases was found after treatment with the test item as compared to the frequencies of the controls. Appropriate mutagens were used as positive controls. They induced statistically significant increases (p < 0.05) in cells with structural chromosome aberrations. In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce structural chromosome aberrations as determined by the chromosome aberration test in V79 cells (Chinese hamster cell line) in vitro. Therefore, the test item is considered to be non-clastagenic in this chromosome aberration test with and without S9 mix when tested up to cytotoxic concentrations.
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