Registration Dossier

Toxicological information

Carcinogenicity

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Description of key information

4,4'-Methylenedicyclohexanamine is not mutagenic, and is not in widespread dispersive use.  A carcinogenicity study is not warranted.

Key value for chemical safety assessment

Additional information

4,4'-Methylenedicyclohexanamine has been well studied for mutagenicity effects, and is evaluated as non-mutagenic. As the majority of known carcinogens are mutagens, this suggests that the substance is not carcinogenic. There is no evidence from repeated dose studies on this substance or on structurally-related substances to suggest hyperplasia or pre-neoplastic lesions. This is an industrial chemical which is not in widespread dispersive use. Carcinogenicity studies require large numbers of live animals, use of which is allowed only as a last resort by the REACH legislation (Article 25.1). While specific carcinogenicity studies are lacking, there is insufficient evidence of neoplastic risk to warrant proposal of a study. 

Justification for classification or non-classification

There is insufficient evidence from existing toxicology data on 4,4'-Methylenedicyclohexanamine to classify this substance as a carcinogen.