Registration Dossier
Registration Dossier
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EC number: 500-036-1 | CAS number: 25214-70-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Justification on read-across of data for the 4,4´-isomer of MDA for oligomeric MDA in the scope of REACH is documented in IUCLID Toxicological information and described in sections 5.1 and 5.11 of the CSR.
Discussion
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).
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 mutagen 2, H341: suspected of causing genetic defect.
According to annex I, directive 67/548/EC, MDA is classified: R68 -Possible risk of irreversible effects
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