Registration Dossier
Registration Dossier
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EC number: 809-896-5 | CAS number: 60435-70-3
Carcinogenicity
Administrative data
Description of key information
In a carcinogenicity study by Sice (1966; rel 4), the tumour promoting activity of a range of alcohols, including octan-1-ol was investigated in mice. Tumour promoting activity was observed in some of the alcohols, including octan-1-ol, with 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 its role in tumour development of non Genotoxic chemicals has been well established. Therefore the relevance of the results from this study for octan-1-ol is questionable.
In a limited study, no carcinogenicity was seen in mice injected thrice weekly with 1-octanol at up to 500 mg/kg bw for 8 weeks (providing a total dose of up to 12 g/kg bw) and observed for a further 16 weeks. (Stoner et al 1973, rel;4).
Key value for chemical safety assessment
Justification for classification or non-classification
Based on the weight of evidence across the category and for octan-1-ol, datais waived as testing is not a scientifically necessary option.
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 octan-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 structurally related alcohols (though reporting is limited in many cases). In addition, octan-1-ol does not have any genotoxic effects and a limited study where mice were injected with octan-1-ol three times a week for eight weeks also gave no indications of any carcinogenic effects.
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