Registration Dossier
Registration Dossier
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EC number: 246-874-9 | CAS number: 25340-17-4
Carcinogenicity
Administrative data
Description of key information
A minimally reported dermal carcinogenicity study in mice
Key value for chemical safety assessment
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
There is no justification for classification as a carcinogen based on the results of this study.
Additional information
A dermal carcinogenicity study on DEB mixed isomers was conducted in mice. Doses of 25 microliters of a 10% DEB in acetone solutions were administered dermally to the backs of 40 C3H/HeJ mice/group, 3 days/week for the lifetime of the test animals, up to 72 weeks. During the dosing period, hyperkeratosis, epidermal hyperplasia, surface crusting, dermatitis, and dermal fibrosis were pronounced. There was no difference in mortality between treated and control animals. A fibrosarcoma and a lymphosarcoma were identified in two of the control mice. A single squamous cell carcinoma (1/40 mice) was identified in the 10% (v/v) DEB group, at the site of application. The authors considered this to be probably treatment-related, given the very low spontaneous incidence of squamous cell carcinoma in male C3H/HeJ mice. However, given the clear lack of in vitro or in vivo genotoxicity for DEB mixed isomer, the induction of epidermal hyperplasia and dermal fibrosis, and the single squamous carcinoma are all considered to be manifestations of a proliferative response at the application site due to prolonged, chronic irritation. Therefore, this finding does not reflect a carcinogenic potential for dermal exposure to DEB mixed isomers.
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