Registration Dossier
Registration Dossier
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EC number: 210-323-0 | CAS number: 612-83-9
Carcinogenicity
Administrative data
Description of key information
Studies in animals demonstrated that 3,3'-dichlorobenzidine is carcinogenic in rats, hamsters, mice and dogs. A similar activity has to be anticipated for the submission substance, 3,3'-dichlorobenzidine dihydrochloride.
Key value for chemical safety assessment
Justification for classification or non-classification
As the base (3,3'-dichlorobenzidine) of the submission substance was clearly carcinogenic in animals but carcinogeniciy could not clearly be demonstrated in humans the submission substance has been classified as carcinogenic category 2 according to Council Directive 67/548/EEC (R45 "May cause cancer"). According to Regulation (EC) No 1272/2008 this would result in a classification as carcinogen category 1B (H350 "May cause cancer").
Additional information
Carcinogenicity of 3,3'-dichlorobenzidine has been clearly demonstrated in animal experiments after oral and subcutaneous exposure. The substance induced tumours of the mammary gland, zymbal gland, liver, bladder, skin and hematopoietic system. Carcinogenic effects have also been observed after transplacental exposure of mice. Epidemiological studies did not clearly demonstrate a carcinogenic effect in humans. Due to these findings a similar activity has to be anticipated for the submission substance, 3,3'-dichlorobenzidine dihydrochloride, which therefore has to be classified as carcinogenic, category 2.
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