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EC number: 849-166-3
CAS number: 83841-00-3
Table: summary of results of plate incorporation test
Table: summary of results of pre-incubation test
The mutagenic potential of the substance was studied under GLP to OECD TG 471 with histidine-dependent auxotrophic mutants of Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a tryptophan-dependent mutant of Escherichia coli, strain WP2uvrApKM101. The bacteria were exposed to the substance diluted in sterile distilled water. Two independent mutation experiments were performed in the presence and absence of liver preparations (S9-mix) from rats treated with phenobarbital and β-naphthoflavone. Experiment 1 was a standard plate incorporation assay and experiment 2 a pre-incubation test. The maximum concentration of the test item in experiment 1 was 5000 µg/plate, the standard limit concentration recommended in the regulatory guideline that this assay follows. This maximum concentration was also selected for experiment 2. There was no toxicity, evident as a reduction in the number of revertants (below an induction factor of 0.5) or a reduction in the background lawn, in any of the five tester strains either with or without S9 mix following exposure to the substance in either the plate incubation or pre-incubation experiments. No test item precipitate was observed on the plates at any of the concentrations tested in either the presence or absence of metabolic activation (S9-mix) in experiments 1 and 2. The vehicle (sterile distilled water) control plates gave counts of revertant colonies generally within the normal range. There were no biologically relevant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any concentration of the test item, either with or without metabolic activation (S9-mix) in experiments 1 and 2. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
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