Registration Dossier
Registration Dossier
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EC number: 248-145-0 | CAS number: 26966-75-6
Carcinogenicity
Administrative data
Description of key information
The carcinogenicity classification of Carc. 1B is read-across from toluene 2,4-diamine. 2,4-TDA is a structural isomers of o-TDA, differing in the substitution pattern of the amine groups on the tolyl ring; having similar physical chemical properties; similar environmental fate; and similar health effects (acute toxicity and genotoxicity). As a result, data from 2,4-TDA can be used for read across to ortho- TDA.
Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
There were no animal studies on carcinogenicity using the oral, dermal or inhalation route of exposure to commercial mixture of TDA (2,4-/2,6 -TDA, 80/20). For the single isomers 2,4-TDA and 2,6-TDA valid long-term feeding studies in rats and mice are available similar to OECD TG 451.
Oral intake to rats at doses of 5.9 mg/kg bw/day 2,4-TDA and more over a period of up to 103 weeks lead to a dose dependent increase of hepatocellular carcinomas or neoplastic nodules in both sexes. In addition, 2,4-TDA induced adenomas and carcinomas of the mammary gland in females as well as fibromas of the subcutaneous tissue and an increased incidence of lung tumors (although statistically not significant) in males (NCI 1979). In mice hepatocellular carcinomas occurred significant in females after oral application of doses of 15 and 30 mg/kg bw/day for 101 weeks. In addition, oral long-life administration of 2,4-TDA may have increased the incidence of lymphomas in female mice. Neoplasms of the lung seen as adenomas and/or adenocarcinomas, and of the hematopoietic system were slightly increased in male mice. But no tumors occurred at significantly increased incidences in male mice (NCI 1979).
In summary, 2,4-TDA was carcinogenic in rats and mice after oral long-term administration.
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