Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
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 a reliable (Klimisch 1) OECD 406 GLP compliant study the skin sensitising potential of octadecan-1-ol has been assessed. Octadecan-1-ol data in this instance has been used provide read-across data for the sensitisation endpoint of tetracosan-1-ol, hexacosan-1-ol, and octacosan-1-ol. In this study octadecan-1-ol was reported to not be a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure. A second reliable (Klimish 1) study following OECD 406 and EU method B.6 guidelines and under GLP compliance examined a mixture of icosan-1-ol and docosan-1-ol in female Dunkin-Hartley guinea pigs. The mixture did not elicit a sensitization response when given a dermal injection of 5% test material concentration in the first week, 75% test material concentration in the second week with a topical application of 10% concentration two weeks after the higher injection. Consequently in line with the read-across justification included, Alcohols, C20-30 (even numbered), is not considered to be sensitising.


Migrated from Short description of key information:
The key study for sensitisation was a reliable (Klimisch 1) OECD 406 study with octadecan-1-ol. In this study the test substance was reported to be non-sensitising.

A reliable (Klimish 1) study following OECD 406 and EU method B.6 guidelines and under GLP compliance examined a mixture of icosan-1-ol and docosan-1-ol in female Dunkin-Hartley guinea pigs and found to mixture to be not-sensitising .

Justification for selection of skin sensitisation endpoint:
This reliable Klimisch 1 study follows EU guidelines and is GLP compliant. Octadecan-1-ol was not reported a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

These findings do not warrant the classification of Alcohols, C20-30 (even numbered),as a sensitiser under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) and under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.