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EC number: 213-208-3
CAS number: 930-02-9
Under the conditions of this OECD 408 repeated dose toxicity test in
Wistar rats the NOAEL was 200 mg/kg bw/d for male and 50 mg/kg bw/d
bw/day for female animals.
Octadecylvinylether was administered in a
repeated dose toxicity study (OECD 408) by gavage to groups of 10 male
and 10 female Wistar rats at dose levels of 0 (test group 0), 50 (test
group 1), 200 (test group 2) and 800 mg/kg bw/d (test group 3) over a
period of 3 months. With regard to clinical examinations, signs of
general systemic toxicity were not observed even at a dose level of 800
mg/kg bw/d. In addition, no test substance-related effects on estrous
cycle length and the number of cycles were obtained. Regarding clinical
pathology, in rats of both sexes of test group 3 (800 mg/kg bw/d)
marginally increased γ-glutamyl transferase (GGT) activities and higher
cholesterol levels were observed reflecting an affection of the liver
cells. Additionally, in females total protein and globulin levels were
increased, most probably due to a greater synthesis of transport
globulins by the liver cells. Globulin and cholesterol levels were
already increased in females of test group 2 (200 mg/kg bw/d). Regarding
pathology, the liver was the target organ. Males and females of test
group 3 (800 mg/kg bw/d) revealed a diffuse hepatocellular hypertrophy
which correlated with the enlargement observed by gross pathology in
females and with the increased liver weight in both sexes. Furthermore,
hepatocytes with vacuoles were detected histopathologically, which could
be shown to be neutral fat storage within the hepatocytes. This
correlated with macroscopic finding of light brown discoloration. For
test group 3 (800 mg/kg bw/d) males and females the hypertrophy and
fatty change was regarded to be treatment-related and adverse in
combination with clinical pathology findings. In test group 2 (200 mg/kg
bw/d) only the centrilobular hypertrophy in a single female and the mean
liver weight increase were regarded to be treatment-related and adverse,
as also clinical pathology parameters were changed in this test group.
The fatty change occurred in different animals than the one with
hypertrophy. These animals did not reveal other findings than the
minimal fatty change, which was regarded to be treatment-related but not
adverse. In the lungs some animals revealed histiocytes within the
alveoli which occasionally showed not only a foamy cytoplasm (as
normally observed in alveolar histiocytes) but clear vacuoles of
variable size. With the ORO stain and electron microscopic evaluation it
could be demonstrated to be neutral fat. As no other changes were
observed in the lungs this was not regarded to be an adverse finding.
Furthermore, it could not be excluded that part of the gavage fluid was
aspired. All other findings occurred either individually or were
biologically equally distributed over control and treatment groups. They
were considered to be incidental or spontaneous in origin and without
any relation to treatment.
another study (OECD 422)Octadecylvinylether was given daily as an oily
solution to groups of 10 male and 10 female Wistar rats (F0 animals) by
stomach tube at doses of 250, 500 and 1000 mg/kg body weight/day (mg/kg
bw/day). Control animals (10 male and 10 female Wistar rats) were dosed
daily with the vehicle only (corn oil). The duration of treatment
covered a 2-week pre-mating and a mating period in both sexes, 2 weeks
post-mating in males, and the entire gestation period as well as
approximately 2 weeks of the lactation period. After 2 weeks of
premating treatment the F0 animals were mated to produce F1 generation
pups. Mating pairs were from the same test group. Mating was
discontinued as soon as sperm was detected in the vaginal smear. F0
animals were examined for their reproductive performance including
determination of the number of implantation sites and the calculation of
postimplantation loss for all F0 females. A
detailed clinical observation (DCO) was performed in all animals before
initial test substance administration and, as a rule, thereafter at
weekly intervals. Food consumption of the F0 parents was determined once
weekly during premating. In dams food consumption was determined for
gestation days 0 - 7, 7 - 14, 14 - 20 and lactation days 1 - 4. Body
weights of F0 parents were determined once a week, in males throughout
the study and in females during premating. During gestation and
lactation period, F0 females were weighed on gestation days (GD) 0, 7,
14 and 20, on the day of parturition (postnatal day [PND] 0) and on PND
4. The pups
were sexed and examined for macroscopically evident changes on PND 0.
They were weighed on PND 1 and on PND 4. Their viability was recorded.
At necropsy on PND 4, all pups were sacrificed with CO2, under
isoflurane anesthesia, and examined macroscopically for external and
visceral findings. Clinico-chemical
and hematological examinations as well as urinalyses were performed in 5
animals per sex and group towards the end of the administration period.
At the end of the administration period a functional observational
battery was performed and motor activity was measured in 5 parental
males and females per group. All
F0 parental animals were sacrificed by decapitation, under isoflurane
anesthesia, and were assessed by gross pathology. Weights of selected
organs were recorded and a histopathological examination was performed.
various analyses: •
Demonstrated the stability of the test substance in corn oil over a
period of 7 days at room temperature
• Verified basically
correct concentrations of the test substance in corn oil preparations.
following test substance-related adverse effects/findings were noted:
Test group 3: 1000
Increased cholesterol, total protein and albumin levels in females
Minimal to severe hepatocellular fatty change in male and female animals
(centrilobular in 6/10
male animals, peripheral or diffuse in 7/10 female animals) in
combination with centrilobular
hepatocellular hypertrophy in 4/10 male animals
group 2: 500 mg/kg bw/day:
Minimal to moderate hepatocellular fatty change in male and female
animals (centrilobular in
4/10 male animals, centrilobular or peripheral in 6/10 female animals)
in combination with centrilobular hepatocellular hypertrophy in 3/10
group 1: 250 mg/kg bw/day
No test substance-related adverse findings
Based on the results obtained in the
repeated dose toxicity study (OECD 408) the test substance has not to be
classified according to Regulation (EC) No 1272/2008 (CLP, GHS).
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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