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Toxicological information

Carcinogenicity

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Description of key information

In a carcinogenicity study by Sice (1966; rel 4), the tumour promoting activity of a range of alcohols, including decan-1-ol was investigated in mice. Tumour promoting activity was observed in some of the alcohols; the maximum effect being observed at C10 (decanol). It was also noted however that skin irritation was present at the application site in all of these skin painting experiments; the most severe irritation being observed with the C10 and C12 alcohols. Unfortunately this is a significant confounder in skin painting studies and the role of sustained irritation  in tumour development of non Genotoxic chemicals has been well established. it is therefore considered likely that the tumour effects noted were due to the irritation  observed in the study.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Species:
mouse
Quality of whole database:
Rel 4 study

Justification for classification or non-classification

Based on the weight of evidence available, decan-1-ol is not classified as carcinogenic under Regulation 1272/2008 (CLP)

 

Additional information

Although Column 2 of REACH Annex X requires a carcinogenicity study (required in Section 8.9.1) if the substance has a wide dispersive use, the weight of evidence across the category suggests that decan-1-ol is not carcinogenic. This is based on a large set of various types of repeated dose studies across the category which do not offer any evidence of treatment-related induction of hyperplasia / pre-neoplastic lesions for 1-decanol or structurally related alcohols (though reporting is limited in many cases). In addition, decanol does not have any genotoxic effects and it is a naturally-occurring substance.