Registration Dossier
Registration Dossier
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EC number: 500-036-1 | CAS number: 25214-70-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key 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 X, fertility studies are not required as MDA is a genotoxic carcinogen and appropriate risk management measures are implemented.
Additional information
Justification on read-across of data for the 4,4´-isomer of MDA for oligomeric MDA in the scope of REACH is documented in IUCLID Toxicological information and described in sections 5.1 and 5.11 of the CSR.
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.
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.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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