Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No studies were located regarding fertility impairment in human or animals after exposure to 4,4´-methylenedianiline by any route.

According to regulation 1907/2006/EC, annex 10, section 8.7 fertility studies are not required as MDA is a genotoxic carcinogen and appropriate risk management measures are implemented.

Effects on developmental toxicity

Additional information

No reliable bioassays were located regarding developmental effects in humans or test animals after exposure to 4,4´-methylenedianiline by any route of exposure. A single study in rats showed that exposure to 4,4´-methylenedianiline during gestation may result in adverse developmental effects (Bourdelat et al. 1983). The study, however, was of limited scope and was not well conducted. A study of uncertain relevance reports that MDA injected into the yolks of fertile eggs reduces hatching frequency and has teratogenic effects (McLaughlin, J., et al, 1963).

According to regulation 1907/2006/EC, annex 10, section 8.7 developmental studies are not required as MDA is a genotoxic carcinogen and appropriate risk management measures are implemented.

Justification for classification or non-classification

Not applicable, since according to regulation 1907/2006/EC, annex 10, section 8.7 studies on reproductive toxicity are not required as MDA is considered as a genotoxic carcinogen and appropriate risk management measures are implemented.