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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

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 body weight/day.

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 treatment-related findings.

 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.

 


Short description of key information:
Vinyl laurate did not show any effects on reproduction up to the highest concentration tested in an test according to OECD guideline 422

Effects on developmental toxicity

Description of key information
Vinyl laurate did not show any signs of teratogenicity up to the highest concentration tested in an test according to OECD guideline 414 
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Vinyl laurate was analyzed for effects on the pregnant rat and development of the embryo and fetus consequent to exposure of the female to the test item from day 6 post coitum (implantation) to day 20 post coitum (the day prior to Caesarean section) according to OECD Guideline 414. Four groups of females were treated by gavage with Vinyl laurate once daily at dose levels of:

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 dams survived until the scheduled necropsy. No clinical symptoms related to treatment with the test item were noted during the study. Mean food consumption, body weight, body weight gain and corrected body weight gain (corrected for the gravid uterus weight) were not affected by treatment with the test item in any dose group.The relevant reproduction data (post-implantation loss and the mean number of fetuses per dam) were not affected by treatment with the test item. No macroscopical findings were noted during necropsy of the dams in any group. During the external examination of the fetuses, no abnormal findings were noted in any group. No test item-related effects on fetal sex ratios were noted in any dose group. Mean fetal body weight did not reveal any test item-related effect. No findings were observed which were considered to be test item-related. No findings, which were considered to be test item-related, were observed during examination of fetal skeletons and cartilages. Based on the results of this study, the NOEL (No Observed Effect Level) for maternal and fetal organisms was considered to be 1000 mg/kg body weight/day. Under the conditions of this study, Vinyl laurate did not reveal any teratogenic potential up to and including 1000 mg/kg body weight/day.

Justification for classification or non-classification

Vinyl laurate did not show any effects on reproduction or signs of teratogenicity up to the highest concentration tested.