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EC number: 941-730-8 | CAS number: -
From the results of this study, it is concluded that the reaction mass is non-mutagenic to any of the five strains of Salmonella typhimurium viz., TA1537, TA1535, TA98, TA100 and TA102 when tested under the specified experimental conditions.
This study was performed to evaluate mutagenic activity of the reaction mass by the bacterial reverse mutation test, using five histidine deficient mutant tester strains of Salmonella typhimurium (i.e., TA1537, TA1535, TA98, TA100 and TA102).
The substance was tested in two independent experiments, in the absence and presence of metabolic activation. Bacterial cultures were exposed totest itemat 8 concentrations (two plates/concentration) between 1.5 to 5000 µg/plate in the initial toxicity-mutation test. Normal background lawn pattern was observed up to the tested concentration of 5000 µg/plate in all tester strains (TA1537, TA1535, TA98, TA100 and TA102), no increase in the number of revertant colonies (no mutagenic effect) was observed both in the absence and presence of the metabolic activation system (5% v/v S9 mix) in all the tester strains. To confirm the negative results obtained in the initial toxicity mutation test, confirmatory mutation test was conducted with an increased S9 concentration i.e., 10% v/v S9 mix andmodified concentration spacing. Bacterial cultures were exposed to test item at 7 concentrations (three plates/concentration) between 78.125 to 5000 µg/plate both in the absence and presence (10% v/v S9 mix) of metabolic activation. After 48 hours of incubation at 37 ± 1°C, the revertant colonies were scored.
Test item did not induce any significant increase in the number of revertant colonies, in both trials, with and without S9 mix, in any of the five tester strains. All the values for the negative control were within historical control ranges of the laboratory and positive controls showed an increase in the number of revertant colonies, demonstrating the efficiency of the test system.
All criteria for a valid study were met as described in the study plan.From results of this study, under the specified experimental conditions, the reaction mass is concluded to be non-mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium.
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