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EC number: 701-326-2 | CAS number: -
Table 7.6.1/2: Test results: Preliminary toxicity test
In a reverse gene mutation assay performed according to the OECD test guideline No. 471 and in compliance with GLP, S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and E.coli strain WP2 uvrA- were exposed to ST 10 C 08 diluted in acetone both in the presence and absence of metabolic activation system (10% liver S9 in standard co-factors) using the plate incorporation method. The dose range for the range-finding test was determined in a preliminary toxicity assay and ranged between 15 and 5000 µg/plate, depending on bacterial strain type. The experiment was repeated on a separate day using a modified dose range, 50 to 5000 µg/plate based on the results of the range-finding test.
The vehicle (acetone) control plates gave counts of revertant colonies within the normal range. 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.
ST 10 C 08 caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. A stringy, oily precipitate, was observed at and above 1500 µg/plate, this did not prevent the scoring of revertant colonies.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
Under the test condition, ST 10 C 08 is not mutagenic with and without metabolic activation in S. thyphimurium strains TA1535, TA1537 TA98 & TA100, and E.coli WP2 uvrA-.
This study is considered as acceptable and satisfies the requirement for reverse gene mutation endpoint.
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