Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The official EU Risk assessment for MDA (2001) concluded the following for Genotoxicity: MDA induces gene mutations in bacteria. In mammalian cell cultures in the presence of an exogenous metabolisation system, MDA is an inducer of chromosomal aberrations. Inconclusive or weak effects were obtained in other cell culture assays.

In vivo, slight increases of micronuclei frequencies were found in mice after treatment to high doses. Furthermore, a high MDA dose led to DNA fragmentation in rat liver cells. Weak marginal effects were obtained for induction SCE (mouse bone marrow) and DNA binding (rat liver). In vivo DNA repair (UDS) tests were negative for livers of rats and mice.

MDA causes concern for man owing to possible mutagenic effects. There is evidence from in vivo micronucleus tests (although only weakly positive) which is supported by the induction of DNA fragmentation in vivo and chromosomal aberrations in vitro. On the other hand, there is not sufficient evidence to place the substance in category 2. Therefore, according to the classification criteria MDA has been classified as category 3 mutagen.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

In regulation 1272/2008/EC, MDA is officially classified as mutegen 2, H341: suspected of causing genetic defect.

According to annex I, directive 67/548/EC, MDA is classified: R68 -Possible risk of irreversible effects