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Toxicological information

Carcinogenicity

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Description of key information

The carcinogenicity of 4,4'-methylene bis (2-chloro-aniline) was tested in various animal studies. The data-set consists of one key study in rats and several supportive literature publications.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
LOAEL
12.5 mg/kg bw/day

Additional information

In one key study in rats a dose-related incidence by "MOCA" of chemically-induced neoplasms and pre-neoplastic lesions was observed after 104 weeks fed with a protein adequate or protein deficient diet. The lung was the most commonly affected tissue. Hepatocellular carcinomas were oberserved as well. Moderately to markedly lower survival rates were noted in all of the treated groups when compared to control groups. In another study, MOCA induced follicular-cell neoplasms of the thyroid gland in rats and hepatocellular carcinomas or adenomas in mice under the tested conditions (104 weeks study). 4,4'-methylene bis (2-chloro-aniline) has been evaluated by the IARC and judged to be carcinogenic in rats and mice in 1974. The carcinogenic potential seems to be established in 5 literature publications as reviewed by McQueen et. al. 1990 and by the IARC monograph of 1993. Unfortunately none of the described experimental studies or cited literature publications investigates the identity, quality, or amount consumed of the tested substance. Therefore, the observed effects under certain test conditions can not be related to definite concentrations of 4,4'-methylene bis (2-chloro-aniline).


Carcinogenicity: via oral route (target organ): digestive: liver; glandular: mammary gland; glandular: thyroids; respiratory: lung; urogenital: urinary bladder

Justification for classification or non-classification

Based on the above mentioned results, 4,4'-methylene bis (2-chloro-aniline) is considered a potential carcinogen to humans and therefore classified according to the Dangerous Substance Directive 67/548/EC: T; Carc. Cat. 2; R45 and CLP Regulation (EC) 1272/2008: Carc. 1b.