Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

For N-methylol methacrylamide, the mutagenicity test in bacteria and HPRT test were negative, the chromosome aberration study in vitro was positive. The in vivo mouse micronucleus assay was negative. That pattern of mutagenicity test results is frequently found in methacrylic acid derivatives. With respect to internationally accepted scientific criteria, the overall data in combination indicate the absence of a mutagenic potential in vivo. Consequently, it is concluded that N-methyl methacrylamide is unlikely to be mutagenic in vivo. This conclusion was already confirmed for N-methylol methacrylamide by the European Scientific Committee for Food (SCF; todays name: EFSA) within the European approval process for monomers intended to come into contact with food (PM / REF 21970).


Short description of key information:
For N-methylol methacrylamide, the mutagenicity test in bacteria and HPRT test were negative, the chromosome aberration study in vitro was positive. The in vivo mouse micronucleus assay was negative. The overall data, supplemented by information of structurally related methacrylic acid derivatives, indicate the non-mutagenicity of the substance in vivo.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

N-methylol methacrylamide was concluded to be non-mutagenic in the view of the overall data, hence the substance has not to be classified according to CLP (1272/2008/EEC) and UN-GHS criteria. Taking into account the rules for mixtures and with respect to the concentration of formaldehyde one composition (60% aqueous solution) has to be classified (EU-GHS category Muta. 2).