Registration Dossier
Registration Dossier
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EC number: 203-268-9 | CAS number: 105-08-8
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
No hyperplasia, pre-neoplastic lesions, or necrosis was observed in groups of male and female rats exposed to up to 1.25% 1,4-cyclohexanedimethanol in the drinking water for 13 weeks and all genotoxicity studies were negative both in the presence and absence of metabolic activation. Based on a weight-of-the-evidence evaluation, 1,4-cyclohexanedimethanol is unlikely to pose a significant risk for the development of any tumor type in humans exposed to this chemical and is not considered to be classified for Carcinogenicity according to GHS.
Additional information
There were no chronic repeat-exposure studies conducted with 1,4-cyclohexanedimethanol available for review. However, results for a guideline repeat-exposure study in which male and female rats were exposed to up to 1.25% of the test material in the drinking water for 13 weeks and a lesser study in which rats were exposed to 1% test material in the feed for 5 weeks suggest that the test material is unlikely to pose a significant risk for the development of a carcinogenic effect. In both studies, no necrosis or hyperplasia was observed in any organ at necropsy. In addition, no mutagenicity/genotoxicity was observed in a bacterial mutation assay or an in vivo mammalian bone marrow chromosome aberration assay. An in vitro mouse lymphoma assay on 1,4-cyclohexanedicarboxylic acid, the primary metabolite of 1,4-cyclohexanedimethanol, was also negative.
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