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EC number: 240-367-6
CAS number: 16260-09-6
Oral (OECD 408, diet), rat: NOAEL ≥ 1000 mg/kg bw/day
HISTORICAL CONTROL DATA
Historical control data for hematology, clinical chemistry and
urinalysis were provided.
There is one study available on the subacute oral toxicity of
(Z)-N-octadec-9-enylhexadecan-1-amide (CAS 16260-09-6) in female
Holtzman rats via oral gavage, which was not performed according to a
specific guideline (Leberco Laboratories, 1962). During 5 consecutive
days, 10 animals were daily administered the test substance in olive oil
in 8 dose intervals of 1 mL total volume, amounting for a daily total
dose of approx. 5000 mg/kg bw/day. During the treatment and a subsequent
23-day post-exposure recovery period, no mortalities and clinical signs
of toxicity were noted. The food consumption and body weight gain
appeared normal in treated animals during the entire study period. At
sacrifice, no gross pathological and histopathological abnormalities
were noted in any of the treated animals. Based on the results of this
study, the NOEL of the test substance in female rats was considered to
be ca. 5000 mg/kg bw/day.
The subchronic oral toxicity of (Z)-N-octadec-9-enylhexadecan-1-amide
(CAS 16260-09-6) was investigated in male and female Wistar Crl: Wi/Br
rats in a GLP-conform study according to OECD 408 (IBR, 1988). Based on
a preliminary 4-week dose-range finding test, the test substance was
administered continuously for a period of 13 weeks to groups of 10
animals per sex and group at dietary concentrations of 1200, 6000, 12000
ppm, corresponding to reported doses of 100, 500 and 1000 mg/kg bw/day
in males and females, respectively. A similar constituted control group
received the plain diet. During the study period, one male treated with
1000 mg/kg bw/day died after 13 weeks shortly prior to necropsy due to a
severe pulmonary edema and hydrothorax. However, since this spontaneous
finding has been observed in rats of this strain before, and no
pulmonary changes were noted in any other animal of this study, the
observed mortality was considered to be coincidental and not
attributable to treatment. No clinical signs of toxicity were observed
in any of the other animals during the 13-week study period. Body
weights as well as food and water consumption in treated animals were
not significantly altered compared to those of controls. At
ophthalmoscopic examination after 6 weeks and at study termination, no
adverse findings on eyes attributable to treatment were noted.
Haematological and clinical chemistry analysis revealed sporadic
differences in some parameters which were not dose-related and thus
considered to be incidental and not toxicologically relevant. All mean
values of haematological and clinical chemistry parameters were in the
range of normal values compared to historical controls. Urinalysis and
determination of organ weights showed no treatment-related difference
between treated and control animals. Gross necropsy and
histopathological examination, including male and female reproduction
organs, did not reveal any findings indicative of treatment-related
effects. Some incidental spontaneous changes in gross pathology and
histopathology were nearly equally distributed among control and dose
group animals, and thus of no toxicological relevance. Based on the
overall effects of the study, a NOAEL of ≥ 1000 mg/kg bw/day for male
and female rats was derived.
The available data on repeated dose toxicity of (Z)-N-octadec-9-enylhexadecan-1-amide
(CAS 16260-09-6) via the oral route do not meet the criteria for
classification according to Regulation (EC) No 1272/2008 and are
therefore conclusive but not sufficient for classification.
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