Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
50 mg/kg bw/day
Additional information

Sprague-Dawley rats were treated with 0, 0.4, 2, 10, and 50 mg/kg 4,4'-methylene bis (2-chloro-aniline) once daily during 42 days (males) or up to 4 days after delivery (females). No effects on the estrous cycle, paring days until copulation, copulation index, fertility index, gestation length, the number of corpora lutea, implantation index, live birth index delivery index, parturition and parenting state were observed in dams. In addition, effects after the administration of test article on total number of pups, number of live pups, sex ratio, live birth index, body weight, body formation and viability index of live pups on day 4 were observed. In conclusion, the NOAEL in the reproductive potential of parents in both sexes and the growth and development in pups was 50 mg/kg/day.

In accordance with column 2 of REACH Annex X, the tests developmental toxicity/teratogenicity and/or two-generation reproductive toxicity (required in sections 8.7.2. and 8.7.3.) do not need to be conducted as the substance is known to be a genotoxic carcinogen. Also, in the combined repeated dose toxicity and reproductive/developmental toxicity test no effects on reproduction were observed. Therefore the no further testing is warranted.


Short description of key information:
Acombined repeated dose and reproductive/developmental study was available, although the substance is known to be a genotoxic carcinogen.

Effects on developmental toxicity

Description of key information
The test was waived.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
50 mg/kg bw/day
Additional information

In accordance with column 2 of REACH Annex X, the tests developmental toxicity/teratogenicity and/or two-generation reproductive toxicity (required in sections 8.7.2. and 8.7.3.) do not need to be conducted as the substance is known to be a genotoxic carcinogen. Also, in the combined repeated dose toxicity and reproductive/developmental toxicity test no effects on the offspring were observed. Therefore the no further testing is warranted.

Justification for classification or non-classification

Based on the results from the combined repeated dose and reproductive/developmental study, the substance does not need to be classified according to theDangerous Substance Directive 67/548/EC andCLP Regulation (EC) 1272/2008.