Registration Dossier
Registration Dossier
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EC number: 202-870-9 | CAS number: 100-61-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro studies
As reported in SCOEL/SUM/178 of December 2012 for N-methylaniline with reference to CCRIS Chemical Carcinogenesis Research Information system, N-methylanile published online (http://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~mYKzKq:4), update 2006 N-methylaniline was not mutagenic in Ames tests with Salmonella typhimurium strains in the absence or presence of S9 mix from different species (Note: online CCRIS refers to Zeiger et all, Environ. Mol. Mutagen. 11(Suppl.12):1-158, 1988). N-methylaniline did not induce unscheduled DNA-synthesis in primary cultures of rat hepatocytes (see online CCRIS with reference to Yoshimi et all, Mutat. Res. 206(2):183-191, 1988). The only positive study regarding genotoxicity of N-methylaniline is reported by NIHS Japan 2010: N-methylaniline induced structural chromosomal aberrations including gaps, but no polyploidy in Chinese hamster lung cells in the absence (no cytotoxicity) and in the presence (about 50 % growth inhibition) of exogenous metabolic activation.
In vivo studies
There were no data available
Conclusion
Based on these results, N-methylaniline was not mutagenic: only one study of chromosomal aberrations is positive but all other in vitro studies are negative. Moreover, N-methylaniline is not classified for genetic toxicity according to annex VI of CLP Regulation (EC n.1272/2008).
Justification for selection of genetic toxicity endpoint
Data from reliable source (Scientific Commitee on Occupational Exposure Limit SCOEL)
Short description of key information:
No genetic toxicity for N-methylaniline (only chromosomal aberration positive but all the others studies are negative).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on these results, N-methylaniline was not mutagenic: only one study of chromosomal aberrations is positive but all other in vitro studies are negative.
Moreover, N-methylaniline is not classified for genetic toxicity according to annex VI of CLP Regulation (EC n.1272/2008).
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