Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

All the studies on in-vitro gene mutation in bacteria with N-Methylaniline show negative results. A comet assay and a chromosomal aberration test with mamalian cells are also available, but these assays give a negative and positive result, respectively. However, the publication of the comet assay refers to earlier publications, which indicate N-methylaniline as mutagenic and carcinogenic. In addition, aniline and N,N-dimethylaniline, present as impurities above 1%, are both classified as carcinogenic (Carc. 2). Hence, N-methylaniline as described in this dossier is considered to be potentially genetic toxic.

Short description of key information:
Various Ames tests on multiple strains show that N-Methylaniline does not induce genetic toxicity in bacterial in-vitro tests. Two different mamalian in-vitro tests show contradictionary results. The key value is based on a chromosomal aberration test most recently performed.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

According to the CLP regulation 1272/2008, classification of N-methylaniline (pure) does not include carcinogeneity. However, according to the same regulation, the test substance presented in this dossier should be classified as potential carcinogenic based on its impurities. In addition, this classification is further justified by the high similarity between N-methylaniline and these two impurities, aniline and N,N-dimethylaniline, together with the reported positive result in a chromosomal aberration test with mamalian cells.