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EC number: 240-367-6
CAS number: 16260-09-6
Oral (OECD 401), rat: LD50 > 2400 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bw
Inhalation: no study available
The acute dermal median lethal dose (LD50) of the test item in the
Wistar strain rat was found to be greater than 2000 mg/kg bw.
The acute oral toxicity of (Z)-N-octadec-9-enylhexadecan-1-amide (CAS
16260-09-6) was investigated in a GLP-conform study performed according
to OECD 401 (Notox C.V., 1986). The test substance diluted in corn oil
was administered to 5 Wistar rats per sex at a limit dose of 2400 mg/kg
bw by oral gavage. During the 14-day observation period, no mortality
and no clinical signs were observed, except for lethargy which was
frequently observed among the animals on Day 1 after treatment. The
weekly body weight gain of the animals was normal during the study, and
no substance-related gross abnormalities were noted at necropsy. Based
on these observations, the oral LD50 value in male and female rats was >
2400 mg/kg bw.
In accordance with Regulation (EC) 1907/2006, Annex VIII, Section 8.5.2,
column 2, testing by the inhalation route is appropriate if exposure of
humans via inhalation is likely taking into account the vapour pressure
of the substance and/or the possibility of exposure to aerosols,
particles or droplets of an inhalable size. The substance
(Z)-N-octadec-9-enylhexadecan-1-amide is a solid with very low vapour
pressure (8.3E-05 Pa at 20 °C) and does not contain respirable particles
in a significant amount. Thus, exposure of humans via inhalation is
unlikely. Therefore, testing for acute toxicity by the inhalation route
is not appropriate and should be avoided for reasons of animal welfare.
In addition, reliable data is available for the oral and the dermal
An acute dermal toxicity study with
(Z)-N-octadec-9-enylhexadecan-1-amide (CAS 16260-09-6) was performed
according to OECD 402 and under conditions of GLP (Harlan Laboratories
Ltd, 2012). Five RccHan:WIST rats per sex were exposed to the test
substance diluted in arachis oil at a limit dose of 2000 mg/kg bw for 24
h under semiocclusive dressing. During the 14-day observation period, no
mortality and clinical signs of toxicity were observed, and no gross
pathological changes were noted at necropsy. All animals showed the
expected body weights during the study, except for one male which showed
bodyweight loss during the first week but expected gain in bodyweight
during the second week. Very slight erythema was noted at the test sites
of 4/5 females (score 1) which abated after 5 days in 3 females and
after 8 days in the fourth. There were no signs of dermal irritation
noted at the test sites of the remaining animals. Based on the results
of this study, a dermal LD50 value > 2000 mg/kg bw was derived for male
and female rats.
The available data on the oral and dermal acute toxicity 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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