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EC number: 240-367-6
CAS number: 16260-09-6
Skin sensitisation (OECD 406): not sensitising
The skin sensitising potential of (Z)-N-octadec-9-enylhexadecan-1-amide
(CAS 16260-09-6) was evaluated in a Split Adjuvant Test performed
according to OECD 406 due to the low solubility of the test substance
(Notox C.V., 1986). In the induction phase of the study, test substance
in corn oil was applied epicutaneously to the skin of the 20 female
Dunkin-Hartley guinea pigs of the test group under occlusive conditions
on Days 0, 2, 4 and 7. The concentration of the test substance in
vehicle was 25% (w/v) on Days 0 and 2 as well as 5% (w/v) on Days 4 and
7 of induction treatment. In addition, 2 intradermal injections of 0.1
mL Freund's Complete Adjuvant (FCA) were performed on Day 4 on either
side of sensitisation area in both the treatment group and the control
group (consisting of 10 female animals). For challenge exposure on Day
21, the test substance at 25, 5, 1 and 0% (w/v) concentration in corn
oil was applied for 24 h to the skin of the left flank of treated and
control animals. Skin reactions were evaluated 24 and 48 h after removal
of the dressing. Except for one animal showing moderate and diffuse
reaction after challenge treatment with 5% of the test substance in corn
oil, no positive reactions were observed after challenge application in
the other animals. Therefore, a sensitisation rate of 5% was obtained,
which, however, did not fulfil the criteria for a positive result in
this study. The reliability of the study was limited since no positive
control was included in the assay. However, the animals of the negative
control group, which actually were challenge controls, did not show skin
reactions attributed to skin sensitisation. Under the conditions of this
assay, it was concluded that the test substance was not sensitising to
The available data on skin sensitisation of (Z)-N-octadec-9-enylhexadecan-1-amide
(CAS 16260-09-6) do not meet the criteria for classification according
to Regulation (EC) No 1272/2008 and are therefore conclusive but not
sufficient for classification.
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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