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EC number: 302-853-7 | CAS number: 94134-83-5
The study was performed to evaluate mutagenic activity of 11-methyldodecyl laurate by the bacterial reverse mutation test, using five histidine deficient mutant tester strains of Salmonella typhimurium (i.e., TA1537, TA1535, TA98, TA100 and TA102).
11-Methyldodecyl laurate was tested in two independent experiments, in the absence and presence of metabolic activation. Bacterial cultures were exposed to test item at 8 concentrations (two plates/concentration) between 0.0015 and 5 µL/plate in the initial toxicity-mutation test. Normal growth was observed up to the tested concentration of 5 µL/plate both in absence and presence of the metabolic activation (5% v/v S9 mix) in the tester strains TA1537, TA1535, TA98, TA100, and TA102. No increase in the number of revertant colonies (no mutagenic effect) was observed both in 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 and modified concentration spacing. Bacterial cultures were exposed to 11-methyldodecyl laurate at 6 concentrations (three plates/concentration) between 0.16 and 5 µL/plate for the tester strains TA1537, TA1535, TA98, TA100, and TA102 both in absence and presence (10% v/v S9 mix) of the metabolic activation. After 48 hours of incubation at 37 ± 1°C, the revertant colonies were scored.
11-Methyldodecyl laurate 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 (95% ethanol) in all strains were comparable with untreated control of respective strains and also with the laboratory historical data of distilled water and other solvents, which shows that the solvent does not have any impact on the growth of the test system, 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 the results of this study, under the specified experimental conditions, test item is concluded to be non-mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium.
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