Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The key studies for skin and eye irritation for alcohols C9-11 linear and branched were both by Cagen (1981; rel 1). The test substance was found  to be an irritant to skin (mean 24+72 hour score for 6 animals 2.67, oedema 1.46 with effects developing into eschar scored as 4 by day 7) but not irritating to eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Additional information

The most recent and high reliability information were assigned as key studies. High reliability supporting studies were also available, which were in accordance with the key information. The studies for skin irritation administered the test material on skin undiluted for 24 hours under occlusive dressing. The recommended administration time is a 4 hour by semi-occlusive application. This deviation results in more pronounced irritant effects than would likely to be evident in a study conducted according to the guideline. In addition, the category trend and evidence that irritant effects which are present in animal studies are not seen in human studies in other alcohols of similar chain length (e.g. 1 -decanol) are taken into consideration in determining the classification outcome.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the available information, alcohols C9 -11 linear and branched are proposed to not be classified for skin or eye irritation in accordance with EC regulation 1272/2008.