Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The UVCB substance to be registered is a mixture of the two Guerbet alcohols 2 -hexyldecan-1-ol & 2-octyldodecan-1 -ol and their corresponding esters with C12 and C14 fatty acids. Skin or eye irritation studies are not available for the UVCB substance. The skin / eye irritation potential is evaluated on the basis of experimental data for Guerbet alcohols and their esters with fatty acids.

Of these two substance classes present in the UVCB substance, the Guerbet alcohols are considered to have the higher impact on the toxicological evaluation, for the following reasons:

-      The two Guerbet alcohols are the major components in the UVCB substance, accounting for appr. 30-50%

-      The ester components are expected to be metabolized to fatty acids and the two free Guerbet alcohols, thus contributing to the fraction of Guerbet alcohols

-      In comparison to the Guerbet alcohol esters, the free Guerbet alcohols have a lower molecular weight, which would favor their uptake

-      Having a free functional group, the Guerbet alcohols are more prone to undergo physiological reactions

 

Guerbet alcohols:

Acute skin and eye irritation studies with the two Guerbet alcohols alcohols 2 -hexyldecan-1-ol & 2-octyldodecan-1 -ol have been conducted. All results showed only slight irritant effects to skin and eye. Additional information is available from the REACH consortium in charge of Guerbet alcohols. All representatives of the category of Guerbet alcohols showed only slight irritant effects in rabbits (skin and eye), and no irritant effects in human volunteers (skin). No data on respiratory irritation are available for any substance of the category of Guerbet alcohols.

Guerbet alcohol esters:

With regard to C12 / C14 fatty acid esters of Guerbet alcohols, no studies were conducted, but a skin and an eye irritation test is available for a close homologue. The close homologue (CAS 101227-09-2) is an ester of the Guerbet alcohol 2 -hexyldecan-1-ol with C16-18 fatty acids. It differs from the esters in the UVCB substance only with regard to the chain length of the fatty acids (close homologue: 2-6 carbon atoms more) and partly in the Guerbet alcohol chain length (close homologue: identical or 2 carbon atoms less). As demonstrated by the skin and eye irritation tests with 2 -hexyldecan-1-ol & 2-octyldodecan-1 –ol, the variation in the chain length of the Guerbet alcohol has no impact. From the difference in the carbon chain of the fatty acid structure in the ester, no different toxicological behavior is expected either. The structural variation does not introduce new functional groups, but only a minor extension of the molecule. Therefore, a read-across to CAS 101227-09-2 seems to be justified. The skin irritation study as well as the eye irritation test with the close homologue CAS 101227-09-2 revealed only slight irritation effects which do not lead to a classification according to the CLP regulation.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The available data are conclusive but not sufficient for classfication of the UVCB to be registered with regard to irritation/corrosion.