Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Betaine has been tested in various in vitro and in vivo settings against genetic toxicity. Betaine has not indicated genetic or clastogenic toxicity even with the relatively high doses used in all of the testing.

Short description of key information:
Betaine has been tested for genetic toxicity in vitro and in vivo, and no toxicity was found. In vitro-testing include EEC Method B14 of Annex V, which was performed in accordance with GLP, EU B.10 standardized method also performed following GLP, and OECD TF 476 performed following GLP. For in vivo-testing OECD TG 474 study in accordance with GLP was performed.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Not classified according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 based on negative results from Ames, chromosome aberration, and mouse lymphoma tests in vitro, as well as mouse micronucleus in vivo.