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Administrative data

Key value for chemical safety assessment

Additional information

Short description of key information:
Based on the results of three reliable in vitro studies (Ames test according to OECD 471, HPRT test according to OECD 476 and Chromosome
aberration assay according to OECD 473), N-[3 -(dimethylamino)propyl)methacrylamide shows no potential to induce gene mutations in bacterial
cells nor does it induce chromosomal aberrations. Therefore, it is concluded that DMAPMA is unlikely to be mutagenic in vivo. This conclusion was supported by an in vivo B6C3F1 mouse bone marrow micronucleus assay (standard NTP protocol) where DMAPMA was not mutagenic.
- not mutagenic in the Salmonella typhimurium reverse mutation assay (OECD guideline 471; GLP, RCC Cytotest Cell Research GmbH, 1994)
- not mutagenic in the mammalian cell gene mutation assay (OECD guideline 476; HPRT test, V79 cells; GLP, CCR Cytotest Cell Research GmbH, 1994)
- negative in an in vitro Chromosome aberration assay in Chinese V79 cells (OECD guideline 473; GLP, CCR Cytotest Cell Research GmbH, 1994)

There is one in vivo genetic toxicity study identified for N-[3 -(dimethylamino)propyl)methacrylamide. In this B6C3F1 mouse bone marrow micronucleus assay (standard NTP protocol) N-[3 -(dimethylamino)propyl)methacrylamide was also negative.

No single key study has been selected, since all available studies were negative.

There is no evidence for mutagenicity from in vitro and in vivo studies.
The data requirements with regard to REACH legislation, annex VII – X, are fulfilled.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of in vitro and in vivo studies N-[3-(dimethylamino)propyl)methacrylamide is not required to be classified for mutagenicity.