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EC number: 946-899-1 | CAS number: -
The test item was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy. The test was performed according to the OECD Guideline 471 (1997) and the EU method B.13/14 of EC 440/2008. The five tester strains TA1535, TA1537, TA98, TA100 and WP2 uvrA were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone. The test item was used as a solution in sterile water for injection. The test item was assayed in the toxicity test at a maximum concentration of 5000 µg/plate and at four lower concentrations spaced at approximately half-log intervals. On the basis of toxicity test results, in the Main Assay using the plate incorporation method, the test item was assayed at five dose levels from 313 to 5000 µg/plate. Neither precipitation of the test item, nor toxicity was observed at the end of the incubation period, with any tester strain, at any concentration tested, in the absence or presence of S9 metabolism.
The test item induced dose-related and large increases in the number of revertant colonies in TA1537, TA98 and TA100 tester strains both in the absence and presence of S9 metabolism. Positive increases in the number of revertant colonies (2.9-fold) were also observed with TA1535 tester strain in the presence of S9 metabolism. All the validity criteria were met. Since a clear positive response was observed, no further experiment was undertaken. It is concluded that the test item induces reverse mutation in bacteria both in the absence and presence of S9 metabolism, under the reported experimental conditions.
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