Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA1535, TA1537 and TA1538 of S. typhimurium were exposed to ethyl-S-lactate at concentrations of 667, 1000, 3333, 6667 and 10000 µg/plate in the presence and absence of mammalian metabolic activation (plate co-incubation). Ethyl-S-lactate was tested up to the limit concentration of 10000 µg/plate. There was no dose-related increase in the number of revertants in any of the test strains with and without activation. The result was negative.

In a mammalian cell cytogenetics assay (chromosome aberration), primary peripheral human lymphocytes cultures were exposed to ethyl-S-lactate at concentrations of 0, 100, 333 and 1180 µg/ml with and without metabolic activation. There was no evidence of chromosome aberration induced over background. Ethyl-S-lactate is not clastogenic in human lymphocytes.

In a mammalian cell gene mutation assay (thymidine kinase (TK) locus), L5178Y mouse lymphoma cells cultured in vitro were exposed to ethyl-S-lactate, at concentrations of 0, 0.3, 1, 3, 10, 33, 100, 333 and 1180 µg/ml in the presence and absence of mammalian metabolic activation. There was no evidence of induced mutant colonies over background.

Ethyl-S-lactate was negative in all three in vitro genotoxicity tests with bacteria and mammalian cells.The substance does not have any genotoxic potential. Therefore, there is no reason to do further studies.

Short description of key information:
Three in vitro genotoxicity studies (Ames test, L5178Y mouse lymphoma test, and chromosome aberration test) were performed with ethyl-S-lactate. All studies gave negative results. The substance is not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Ethyl-S-lactate was negative in the in vitro gene mutation tests with bacteria and mammalian cells. From this it is concluded that ethyl-S-lactate is not genotoxic. No classification is required.