Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
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

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
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.