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Additional information

The mutagenic potential of the test article (Clear colorless liquid, Lot 529783, 99% CASRN 4303-67-7) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA1535, and TA1537 and E. coli strain WP2 uvrA in the presence and absence of a metabolic activation system (Aroclor induced S9-mix). The study was performed in compliance with FDA GLP 21 CFR Part 58 and OECD GLP regulations. The test method was based on OECD 471 (1997). Ethanol was used as the vehicle at all test article doses. A toxicity-mutation assay was conducted with the test article up to 5000 ug/plate with all tester strains in the presence and absence of metabolic activation to establish the dose-range for the confirmatory mutagenicity assay. In the confirmatory mutagenicity assay, the test article was tested up to 150 ug/plate in the absence of S9 and up to 500 ug/plate in the presence of S9 with all tester strains. Strain specific positive controls and vehicle controls were tested in parallel.  No increase in revertant colonies was observed in either the presence or absence of metabolic activation in any strain tested. All criteria for a valid test were met as described in the protocol.  Under the conditions of this study, the test material was not mutagenic in the Bacterial Reverse Mutation Assay.

 

The mutagenic activity of the test material (supplied as a liquid, no data on purity, CASRN 4303-67-7, batch 001) was evaluated in the Salmonella typhimurium reverse mutation assay (strains TA1535, TA1537, TA1538, TA98, and TA100) in the presence and absence of a metabolic activation system (S9-mix) following the plate incorporation methodology described by Ames et al. (1975). The test material was prepared in ethanol to the appropriate concentrations. A dose rangefinder determined that the test material was toxic at doses higher than 15 ug/plate. The test material was tested at concentrations up to 15 ug/plate with and without S9-mix. The test material and appropriate positive and negative controls were evaluated in triplicate in each strain. All criteria for a valid study were met as described in the protocol. In all strains, there was no increase in revertant colonies either in the presence or absence of S9-mix relative to the controls. Under the conditions of this study, the test material was not mutagenic in the Salmonella typhimurium reverse mutation assay in the presence or absence of S9-mix.

 

 The mutagenic activity of the test article (supplied as liquid, no data on purity, CASRN 4303-67-7, batch P4505001) was evaluated in the Salmonella typhimurium reverse mutation assay (strains TA98 and TA100) in the presence and absence of a metabolic activation system (S9-mix: phenobarbital and B-napthoflavone-induced rat liver) following the plate incorporation methodology described by Ames et al (1975) and updated by Maron and Ames (1983). The test article was tested as received at concentrations up to 5000 ug/plate with and without S9-mix. The test material and appropriate positive and negative controls were evaluated in triplicate in each strain. Toxic effects were noted at concentrations greater than and equal to 33 ug/plate. Due to these toxic effects a second assay was performed to test concentrations ranging from 0.125 to 3 ug/plate. In both experiments, no substantial increase in revertant colonies was observed in the presence and absence of S9-mix. All criteria for a valid study were met as described in the protocol. Under the conditions of this study, the test article was not mutagenic in the Salmonella typhimurium reverse mutation assay in the presence or absence of S9-mix.


Short description of key information:
In vitro genetic toxicity studies have been conducted on Laurylimidazole.
The results of the studies are: Bacterial Reverse Mutation Assay: Not mutagenic when tested according to to OECD 471.

Bacterial Reverse Mutation Assay: Not mutagenic when tested according to a protocol equivalent to OECD 471.

Screening Bacterial Reverse Mutation Assay: Not mutagenic when tested according to a protocol equivalent to OECD 471.

Endpoint Conclusion:

Justification for classification or non-classification

Criteria for classifying the test article as mutagenic were not met.