Registration Dossier

Toxicological information

Carcinogenicity

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Description of key information

No standard test for carcinogenicity is available for dicumyl peroxide. Based on the available information the substance can be regarded as a weak promotor. 
Further testing on carcinogenicity is not regarded necessary based on the negative findings in in vitro genotoxicity tests.

Key value for chemical safety assessment

Additional information

Dicumyl peroxide is able to induce short term markers of tumour promotion, like epidermal hyperplasia, ornithine decarboxylase, and dark basal keratinocytes. However, results from initiation/promotion studies in mice over 60 weeks indicate that dicumyl peroxide is only a weak tumour promotor. After initiation with DMBA dicumyl peroxide at 6 and 20 mg leads to 0.13 and 0.44 papillomas per mouse. At 60 mg one spindle cell carcinoma was observed.

As dicumyl peroxide was found to be negative in genotoxicity tests in vitro and showed only weak activity as a tumour promotor further testing on carcinogenicity is not regarded necessary. Therefore, no test proposal according to Annex X of Regulation (EC) No 1907/2006 has been provided by the registrant.

Justification for classification or non-classification

As dicumyl peroxide was found to be negative in genotoxicity tests in vitro and showed only weak activity as a tumour promotor the overall conclusion can be drawn that the substance has no carcinogenic potential.