Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The FDA report, mutagenic evaluation of compound FDA 71 -55, comprises several studies investigating genotoxicity of this substance in vitro and in vivo. In thein vitro studies, 4 host-mediated assays including two bacteria (S. typhimurium) and two yeast (Saccharomyces cerevisiae) tests, and a mammalian chromosome aberration test (Human embryonic lung cultures) were conducted at different concentration levels. In the in vivo studies, two dominant lethal tests and two mammalian bone marrow chromosome aberration tests were carried out in different series of concentrations in rats. No genetic toxicity was found in those tests in all investigated concentrations. So it can be concluded that L (+)-tartaric acid is non-mutagenic.


Short description of key information:
no genetic toxicity of tartaric acid was found through in vitro and in vivo experiments.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

non-classification