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The official EU Risk assessment for TDA (2007) concluded the following for Genotoxicity: 2,4-Toluenediamine induces genotoxic effects in bacteria (gene mutations) and cultivated mammalian cells (chromosomal aberrations, SCE, UDS, DNA strand breaks, DNA adducts).

In general, rodent in vivo micronucleus tests were negative in bone marrow or peripheral blood; a weak positive effect in a rat strain was limited to a dose with high acute toxicity. However, in other tissues clear genotoxic effects were obtained which were not limited to highly toxic doses, e.g. gene mutations, UDS, DNA strand breaks and DNA adducts were observed in rodent livers.

Negative results were found in dominant lethal and sperm morphology tests; however, due to low sensitivity these findings are not adequate for exclusion of germ cell mutagenesis.

Although there is some indication for effects on the testes from a non-standard assay measuring a reduction of murine testicular DNA synthesis after 2,4-TDA we do not regard the available mutagenicity data as sufficient to classify 2,4-TDA as a category-2 mutagen.

On the basis of the positive findings on somatic cells in vitro and in vivo we rather propose to classify the substance as a category-3 mutagen.

Endpoint Conclusion:

Justification for classification or non-classification