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Toxicological information

Carcinogenicity

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Description of key information

Two reliable chronic carcinogenicity studies on policosanol in rats and mice resulted in no carcinogenic outcomes after oral administration. The NOAEL from both studies was 500 mg/kg bw/day.

Key value for chemical safety assessment

Additional information

 

Alcohols, C20-30 (even numbered), is a UVCB substance that comprises several linear long chain alcohols, predominantly tetracosan-1-ol (C24), hexacosan-1-ol (C26), and octacosan-1-ol (C28). Together, these substances make up approximately 70% of the composition of Alcohols, C20-30 (even numbered). Other constituents include, to a much lesser extent, secondary long chain alcohols and complex mixtures of long chain carboxylate esters. On this basis, study data, where available, for each of the long chain alcohol constituents has been evaluated and considered together; this is consistent with the Category approach applied for Long Chain Alcohols (LCA) under REACH.   In a conservative approach the most sensitive study result from the constituents of the LCA category have been identified and used to address the endpoint in question.

In accordance with Column 2 of REACH Annex X, the carcinogenicity study (required in Section 8.9.1) does not need to be conducted since both supporting substances are not classified as mutagen Category 3, and there is no evidence from repeated dose toxicity studies that these substances in this category have any potential to cause hyperplasia or pre-neoplastic lesions. 

 

In a reliable (Klimisch 2) study following guidelines similar to OECD 451, policosanol was administered to Sprague Dawley rats via oral gavage for 24 months. Additionally, a reliable (Klimisch 2) study following similar guidelines administered policosanol to Swiss mice via oral gavage for 18 months. Both study doses were up to 500 mg/kg/day. Results from both studies revealed no evidence of carcinogenicity.

Justification for classification or non-classification

Based on the weight of evidence, the data is waived as testing is not a scientifically necessary option for this endpoint.