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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 the test material diluted in DMSO both in the presence and absence of metabolic activation system (10% liver S9 in standard co-factors) using both the Ames plate incorporation and pre-incubation methods at up to six dose levels, in triplicate. The dose range for the range-finding test was determined in a preliminary toxicity assay and was 50 to 5000 μg/plate. The
experiment was repeated on a separate day (pre-incubation method) using an amended dose range (15 to 5000 μg/plate), fresh cultures of the bacterial strains and fresh test item formulations. An additional dose level and an expanded dose range were selected in the main test in order to achieve four non-toxic dose levels and the toxic limit of the test item.
The vehicle (dimethyl sulphoxide) 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.
In the range-finding test (plate incorporation method) the test item caused no toxicity in terms of weakened bacterial background lawns. However, decreases in revertant colony frequency were noted for several of the Salmonella strains at 5000 μg/plate. In the main test (pre-incubation method) the test item induced toxicity to all of the Salmonella strains as weakened bacterial background lawns and/or decreases in revertant colony frequency, initially from 1500 μg/plate in the absence and presence of S9-mix. In the range-finding test (plate incorporation method) the test item caused no toxicity in terms of weakened bacterial background lawns. However, decreases in revertant colony frequency were noted for several of the Salmonella strains at 5000 μg/plate. In the main test (pre-incubation method) the test item induced toxicity to all of the Salmonella strains as weakened bacterial background lawns and/or decreases in revertant colony frequency, initially from 1500 μg/plate in the absence and presence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method
Under the test conditions, test item is not considered as mutagenic in S. typhimurium (TA1535, TA1537, TA98 and TA100) and E. coli WP2 uvrA strains.
This study is considered as acceptable and satisfies the requirement for reverse gene mutation endpoint.
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