Registration Dossier

Administrative data

Description of key information

OECD 404, rabbit, 4h semiocclusive: not irritating 
OECD 405, rabbit, not rinsed: not irritating

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)

Additional information

There is data from an in vivo skin irritation study in rabbits according to OECD Guideline 404 available (Hempstock, 1998; Sponsor: Kao Corporation). In this study 3 animals were exposed to 0.5 g of moistened Fatty Amide O-N (oleamide) for 4 hours on shaved skin under semiocclusive conditions. After the exposure period test substance remains were gently removed and the skin reactions were assessed 1, 24, 48 and 72 hours after removal of the patch. No signs of skin irritation were noted during the study, and observations were terminated after 72 hours. Under the conditions of the study the test material was not irritating to the skin.

Data for eye irritation is available from an in vivo study in rabbits conducted with Fatty Amide N-O (oleamide) in compliance with OECD Guideline 405 (Hempstock, 1997; Sponsor: Kao Corporation). In this study 0.1 ml of test substance (corresponding to 62 mg) were initially installed into the right eye of 1 animal, the left eye remained untreated and served as control. Immediately after administration an assessment of the initial pain reaction was made. After consideration of the ocular responses in the first animal, the other 2 were treated in identical manner. In order to minimise pain on application these animals had received one drop of local anaesthetic before application. Readings were performed at 1, 24, 48 and 72 hours and after 7 days to address reversibility. No corneal or iridial effects were observed during the 7-day observation period of the study. Slight to moderate redness and chemosis of the conjunctivae were observed, which were completely reversible within the observation period and which were not sufficient to induce a classification acording to the criteria of the DSD or the CLP regulation. Therefore, the test material does not have to be considered as irritating to the eyes.

Justification for classification or non-classification

According to the criteria of the DSD and the CLP regulation the substance does not have to be classified as irritating to the skin or irritating to eyes.