Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 931-801-1 | CAS number: -
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
