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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Information is available from a reliable bacterial mutagenicity study on C7, 8 and 9 alcohols; predominantly linear. For endpoints where there is no information on C7, 8 and 9 alcohols, predominantly linear, key studies were chosen from studies on closely related linear or branched alcohols of similar chain length. The choice of key study was based on reliability and similarity of chain length. The data available from standard in vitro and in vivo genetic toxicity assays for all related substances show no evidence of mutagenic potential.

Short description of key information:
In vitro information:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in S. typhimurium strains TA 98, TA100, TA1535 and TA1537 (OECD TG 471)
Cytogenicity in mammalian cells: the related substance C12 and 13 alcohols; linear and monobranched, type 2: negative in CHO cells (OECD TG 473)
Mutagenicity in mammalian cells: the related substance 2-ethylhexan-1-ol: negative with and without activation in L5178Y mouse lymphoma cells (similar to OECD TG 476)

In vivo
Chromosome aberration study in rats: the related substance dodecan-1-ol was negative in mice after oral administration (gavage)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

C7, 8 and 9 alcohols; predominantly linear is a member of the category aliphatic alcohols. The category members contain no structural elements which may be of concern for potential mutagenic activity. In vitro tests over the carbon range (C6-22) of the long chain alcohols category members (primary aliphatic alcohols) and supporting substances (C5-C24-34) are negative including a study for C7, 8 and 9 alcohols, predominantly linear [Ames]. Evidence from in vivo studies on other category members supports the conclusion from in vitro studies that these alcohols are not genotoxic. In vivo data of reliability 1 or 2 in support of this conclusion are available for 2-ethyl hexanol (supporting) [negative chromosome aberration assay] and 1-dodecanol [negative micronucleus assay].