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EC number: 931-801-1
CAS number: -
There is no test data from sensitisation studies available for oleamide.
Therefore, read-across data from a Local Lymph Node Assay (LLNA),
performed with the structurally related substance erucamide (CAS
112-84-5) according to OECD Guideline 429, was considered for regulatory
purposes (Schmitt, 2010).
Erucamide is the fatty acid amide resulting from the amidation of erucic
acid. Erucic acid is a mono-unsaturated fatty acid with a carbon chain
consisting of 22 carbon atoms with a double bond at position 13
(omega-9) of the carbon chain (cis-docos-13-enoic acid). Comparable to
stearamide it is not classified in Annex I of Directive 67/548/EEC, and
does not have to be self-classified according to the available
experimental data. Erucic acid is also present in various oils and fats
which are part of our diets (20-40% in oils from mustard seeds and up to
60% in original high erucic rapeseed oil, <2% in low erucic acid
rapeseed oil; Beare-Rogers, 2001) and will also be broken down into
shorter-chain fatty acids in the process of beta-oxidation. One of the
most famoust uses is in Lorenzo's oil, a 4:1 mixture of the triglyceride
forms of oleic and erucic acid, i.e. an investigational drug used for
the treatment of adrenoleukodystrophy, for which an U.S. Patent was
In this study the ears of 5 mice per group were topically treated with
concentrations of 5, 10 and 25% of erucamide in tetrahydrofuran for 3
consecutive days. Five days after the first treatment the mice received
an intravenous injection of tritiated thymidine. Five hours after
treatment the mice were euthanised, the cells of the draining auricular
lymph nodes were dissected, and the incorporated radioactivity was
determined as number of disintegrations per minute (DPM) by means of a
β-scintillation counter. Stimulation Indices were calculated as ratio of
respective DPM of the individual animals from the treated groups versus
the mean DPM of the control group. Subsequently, group mean Stimulation
Indices of 0.81, 0.84 and 0.70 were determined for the 5%, 10% and 25%
group, respectively. According to the criteria of OECD Guideline 429 the
structurally related substance erucamide does not have to be regarded as
Considering the similarity of physical chemical properties and of other
toxicological parameters to erucamide, oleamide does not have to be
considered as skin sensitising, either.
According to the criteria of the DSD and the criteria of the CLP
regulation the substance does not have to be classified as skin
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.
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