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EC number: 446-240-3 | CAS number: -
Table 1 : Test Results: Experiment 1 – Preliminary Toxicity Test : with and without metabolic activation and results of concurrent positive controls
Without S9 Mix
With S9 Mix
Revertants per plate
0 = vehicle control (Ethanol)
T = toxicity : score = 0, none, 1 = slight, 2 = moderate, 3 = considerable to total
E = Emulsion of test item: score = 0, none, 1 = slight, 2 = moderate, 3 = strong
Table 2 : Test Results: Experiment 2 – Main Test (pre-incubation method) : with and without metabolic activation and results of concurrent positive controls
The study was performed to the requirements of OECD Guideline 471, Japanese guidelines for bacterial mutagenicity testing and EU Method B.14, under GLP, to evaluate the potential mutagenicity of the test item in a bacterial reverse mutation assay using S.typhimurium strains TA98, TA100, TA1535, TA1537 and E.coli strain WP2uvrA- in both the presence and absence of S-9 mix activation system. The test strains were treated in two independent experiments with the test item, utilising the Ames plate incorporation method and then preincubation method, respectively at up to five dose levels, in triplicate, both with and without the addition of a rat liver microsomal metabolic activation system (10% liver S9). The vehicle was ethanol. The dose range for Experiment 1 was predetermined based on the results of a preliminary toxicity assay. The evaluation of toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn. The Experiment 1 dose levels were 312.5, 625, 1250, 2500 and 5000 µg/plate for all Salmonella strains: TA98, TA100, TA1535, TA1537 and for E.coli strain WP2uvrA-. The experiment was repeated using the same dose range by the pre-incubation method in Experiment 2. All of the positive controls used in the test induced expected increases in the frequency of revertant colonies, both with or without metabolic activation. The vehicle controls were considered acceptable. Therefore the assay was considered valid. The maximum dose level of the test item in the Experiment 1 and Experiment 2 was the maximum recommended dose level of 5000 μg/plate in all tester strains. A slight emulsion was observed in the plates when scoring the revertants mainly at the highest dose-level. Without S9 mix, a slight to moderate toxicity was generally induced, depending on the dose-levels and the tester strains. With S9 mix, except for a slight decrease in the number of revertants, noted in the second experiment (preincubation method) in the TA1537 and TA100 strains at the highest dose-level, no noteworthy toxicity was induced in both experiments. There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9 mix). It was concluded that, under the conditions of this assay, the test item gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA98, TA100, TA1535, TA1537 and E.coli strain WP2uvrA- in the presence and absence of S-9 mix.
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