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EC number: 218-414-7
CAS number: 2146-71-6
The effects of Vinyl laurate on the possible health hazards likely
to arise from repeated exposure over a relatively limited period of time
were assessed in a OECD 422 study. In addition this combined repeated
dose toxicity study with the reproduction/ developmental toxicity
screening test in the Han Wistar rat provides information on possible
effects on male and female reproductive performance such as gonadal
function, mating behavior, conception, development of the conceptus and
parturition. Vinyl laurate was administered to male rats for at least 28
days and to female rats for 14 days prior to pairing, through the
pairing and gestation periods until the F1 generation reached day 4 post
partum. The following dose levels were applied: Group 1: 0 mg/kg body
weight/day (control group), Group 2: 50 mg/kg body weight/day, Group 3:
250 mg/kg body weight/day, Group 4: 1000 mg/kg body weight/day. A
standard dose volume of 5 mL/kg body weight with a daily adjustment to
the actual body weight was used. Control animals were dosed with the
vehicle alone (corn oil). All parent animals survived until the
scheduled necropsy. No clinical signs or observations were noted for any
male or female in any groups during the duration of the study. No test
item-related findings were noted in the Functional Observational
Battery. Mean food consumption and body weights were note affected by
treatment with the test item in the males and females during the study.
No test item-related effects were noted from the clinical laboratory
investigations. All female mated. No effects were noted in the
reproduction and breeding data. No test item-related effects were noted
in the organ weights. No test item-related macroscopical or
histopathological findings were observed. No test item-related findings
at first litter check and during lactation were noted. Pup weights to
day 4 post partumwere unaffected by treatment with the test item. No
test item-related macroscopical findings were observed in the pups. The
general NOEL (No Observed Effect Level) was considered to be 1000 mg/kg
body weight/day. The NOEL (No Observed Effect Level) for
reproduction/developmental toxicity was also considered to be1000 mg/kg
The safety of vinyl laurate was examined in a sub-chronic oral
toxicity study in Wistar Outbred rats (RccHan:WIST) according to OECD
testing guideline 408. Vinyl laurate was administered as a dilution in
corn oil by daily oral gavage during 13 weeks at dose levels of 0
(vehicle only), 50, 250 and 1000 mg/kg body weight/day. After the last
treatment 10 rats/sex/group were killed, while 5 rats/sex in the control
and the high-dose group were kept untreated for a recovery period of
4weeks. Additional fertility parameters (estrus cycle and sperm
evaluation) were included in this study. The homogeneity, content and
stability of test substance in the carrier were confirmed by
analysis.None of the animals died during the study and there were no
treatment-related clinical signs. Neurobehavioural observations and
motor activity assessment did not indicate any neurotoxic potential of
the test substance.Ophthalmoscopic examination did not show any
treatment-related ocular changes.
There were no relevant changes in body weight, feed intake or
water intake.Haematology, conducted in 10 rats/sex/group at necropsy,
did not reveal any changes in red blood cell variables, clotting
potential, or in total and differential white blood cell counts.
Clinical chemistry, conducted in 10 rats/sex/group at necropsy, did not
reveal any differences in clinical chemistry variables.
Urinalysis conducted in 10 rats/sex/group in week 13 of the study,
did not reveal any treatment-related changes in renal concentrating
ability, in semi-quantitative (dipstick) urinary measurements or in
microscopy of the urinary sediment. There were no treatment-related
differences in absolute and relative organ weights at the end of the
treatment or the recovery period. Macroscopic examination at necropsy
and microscopic examination of organs and tissues did not reveal
Fertility parameters (estrus cyclicity, testicular sperm count,
epididymal sperm count, sperm motility and sperm morphology) were not
affected by the treatment. Because the administration of vinyl laurate
at levels up to 1000 mg/kg body weight/day did not induce any relevant
changes, the no-observed-adverse-effect level (NOAEL) was placed at 1000
mg/kg body weight/day.
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