Registration Dossier

Administrative data

Description of key information

Skin Irritation/Corrosion
The key study for skin irritation/corrosion was a reliable (Klimisch 1) OECD 404 study with docosan-1-ol. In this study docosan-1-ol was considered not to be a skin irritant when applied to rabbit skin.
Eye Irritation
The key study for eye irritation was a reliable (Klimisch 1) OECD 405 study with docosan-1-ol. In this study docosan-1-ol was considered not to be an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

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

 

Skin Irritation/Corrosion

A reliable (Klimisch 1) OECD 404 study was conducted with docosan-1-ol. Rabbits were treated with undiluted docosan-1-ol in a 4 hour semi-occlusive exposure. No evidence of skin irritation was noted during the study other than very slight erythema at one test site at 1 hour after patch removal. All other scores were 0. Docoson-1-ol was considered not irritating to rabbit skin. Consequently in line with the read-across justification included, Alcohols, C20-30 (even numbered), is considered to be non-irritating.

 

Eye Irritation

A reliable (Klimisch 1) OECD 405 was conducted with docosan-1-ol. Moderate conjunctival  irritation was  reported in all animals one hour after treatment with  minimal to moderate  conjunctival  irritation at  the 24 hour observation time. At 48 hours minimal conjunctival redness was observed in one animal only. All scores were 0 at 72 hours. Docoson-1-ol was considered not irritating to the rabbit eye. Consequently in line with the read-across justification included, Alcohols, C20-30 (even numbered), is considered to be non-irritating to eyes. 


Justification for selection of skin irritation / corrosion endpoint:
This was a reliable Klimish 1 study that followed the OECD 404 guidelines and was GLP compliant. Female New Zealand White rabbits were exposed to 4 hours of semiocclusive treatment with docosan-1-ol. All rabbits had a PMII score of 0.

Justification for selection of eye irritation endpoint:
This was a reliable Klimish 1 study that followed the OECD 404 guidelines and was GLP compliant. Male and female New Zealand White rabbits were exposed to docosan-1-ol. Moderate conjunctival irritation was reported in  all animals one  hour after treatment, but all scores were 0 at 72 hours.

Justification for classification or non-classification

These findings do not warrant the classification of Alcohols, C20-30 (even numbered), as skin or ocular irritants 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.