Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

L-alanine did not show mutagenicity in the Ames test under the conditions of the study.

L-alanine is a normal constituent in living cells occurring as a free amino acid, bound to RNA and incorporated in proteins and peptides. In vitro gene mutation studies did not reveal any mutagenic activity of L-alanine.

These results were foreseeable as L-alanine is a naturally occurring none essential amino acid. It is ingested daily in significant amounts. Therefore human exposure through food is orders of magnitude higher than the anticipated levels of exposure from the uses covered by this dossier. L-alanine is present in significant amounts in human body fluids as well as in human cells. It is a basic metabolite and building block of all living organisms and therefore a genotoxic/mutagenic potential could be excluded.

Justification for selection of genetic toxicity endpoint
Key study

Short description of key information:
L-alanine is not mutagenic in a bacterial reverse mutation assay.
L-alanine is not considered as a mutagen.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

L-alanine is negative in bacterial mutation tests. Furthermore, as L-alanine is a ubiquitously occurring substance in food, the environment and even in human bodyfluids there is no concern with respect to mutagenicity. L-alanine should not be classified as a mutagen.