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EC number: 931-801-1
CAS number: -
RA-S CAS 112-84-5, subacute oral (4 weeks), rat: NOAEL = 10000 mg/kg bw/d (converted from 100000 ppm in feed)
There is no data on repeated dose toxicity available for oleamide.
The only available data which can be used for a first assessment of
repeated dose toxicity of fatty acid amides is a subacute 4-week feeding
study with erucamide (CAS 112-84-5) in weanling rats (Wisconsin Alumni
Research Foundation, 1960) which was well-conducted considering the time
of realisation. In this study 5 male weanling rats of 45-50 g of body
weight were fed with a diet containing an extremely high concentration
of 100000 ppm (10 % w/w) of erucamide at the expense of sucrose which
were compared to a control group fed on a diet without added fat.
Individual body weight and food consumption data were collected weekly;
the total output of feces was collected daily, and pooled weekly fecal
samples were weighed and analysed for their fat content. At the end of
the 4-week feeding period the animals were subjected to routine
hematology and urinalysis, then the animals were sacrificed and a gross
pathological examination was performed. Additionally histopathological
samples were prepared for possible subsequent examinations.
No mortality occurred during the course of the study, and no clinical
signs of toxicity were observed. The treated animals showed slightly
lower body weight gain than the control, but their food consumption was
lowered, as well, while food efficiency was comparable. However, due to
the high substance concentration in the food the reduced food
consumption could well be a sign of food denial because of palatability
problems which is commonly observed in feeding studies with high
substance concentrations. Reduced body weight gain then has to be
considered as a secondary effect due reduced food consumption, but not
as sign of systemic toxicity. Weekly numbers of 72.9, 57.3, 68.6 and
52.8% test substance absorption for the first, second, third and fourth
week, respectively, were obtained. No effects were observed in
hematology and urinalysis parameters, and the animals did not show any
gross pathological abnormalities. Therefore, a concentration of 100000
ppm of erucamide in feed, which can be converted to a dose of 10000
mg/kg bw/day, was considered as NOAEL. Conversion was done based on the
recommendations by the Toxicologist's Pocket Handbook (CRC Press, 2000).
The applied conversion factor considers the typical amount of food
uptake of animals at that respective age and weight. Although only 4
weeks in duration this study already impressively demonstrates that the
tested substance does not exert any sytemic toxicity effects due to the
extremely high concentration chosen for dosing. Even if the resulting
NOAEL is corrected for duration by use of an assessment factor of 3, as
suggested by the "ECHA Guidance on information requirements and chemical
safety assessment - Chapter R.8: Characterisation of dose
[concentration]-response for human health" for the conversion of
subacute NOAELs to subchronic ones, the resulting corrected NOAEL of
3333 mg/kg bw/d will still be more than 10-fold higher than the dose
level resulting in a classification for STOT-Repeated Exposure.
Due to the fact that the duration of the study is not sufficient to
cover the demands of a substance registration with more than 1000
tonnes/year, a 90-day subchronic repeated dose toxicity study according
to OECD Guideline 408 is proposed by the Lead Registrant for the
structurally related substance erucamide (CAS 112-84-5) who is also a
member of the Fatty Amides Consortium. Those results will be shared and
used for a read-across to satisfy the data requirements for repeated
dose toxicity of oleamide, as well. The utilisation of such surrogate
data from a structurally related substance for regulatory purposes is
reasonable and justified, especially in the light of animal welfare and
considering the physical chemical and toxicokinetic similarities of
stearamide and erucamide. Therefore, no individual repeated dose
toxicity study with oleamide is proposed.
According to the criteria of the DSD and the criteria of the CLP
regulation, the substance does not have to be classified for specific
target organ systemic toxicity after repeated exposure.
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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