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Key value for chemical safety assessment

Effects on fertility

Description of key information

Toxicity to reproduction

Two studies were carried out in accordance with the Chinese testing guidelines for chemicals (similar to OECD methods no. 415 and 416); a one-generation and a two-generation study on Kun Ming mice.

In the one-generation study, rnice (60 males and 140 femles) were administered bv gavage daily in doses of 63.20, 7 90 amd 0.99 mg/kg bw of the test substancc and one control group. During the experimental period, reproduction toxicity indices for parental and offspring anirnals were detected for each group. The results showed no significant difference between test group and control group animals on mating index, fecundity index, 4-day and 21-day survival index, body weights of the dams, litter weight, live fetus weights, placenta weights, nidation, post-implantation loss, early dead fetuses, pups growth and development and pups sex ratio. The results indicated that there were no reproduction toxicity effects of the test item when administered by gavage daily in parental and offspring mice.

In the two-generation test, also the same number of mice (60 males and 140 femnales) were administered bv gavage daily in doses of 63.20, 7 90 amd 0.99 mg/kg bw of the test substancc and one control group. During the experimental period, reproduction toxicity indices for parental and offspring anirnals were detected for each group. The results showed no significant difference between test group and control group animals on mating index, fecundity index, 4-day and 21-day survival index, body weights of the dams, litter weight, live fetus weights, placenta weights, nidation, post-implantation loss, early and late dead fetuses, pups growth and development and pups sex ratio. The results indicated that there were no reproduction toxicity effects of the test item when administered by gavage daily in parental and offspring (F1 and F2) mice.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
mouse
Quality of whole database:
Guideline study; Klimisch 2 (non-GLP)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Prenatal developmental toxicity / teratogenicity

A study was carried out according to the Chinese testing guidelines for chemicals (similar to OECD no. 414) on Wistar rats.Young adult nulliparous animals were used, one male was mated with wo females, day 0 of gestation is the day on which a vaginal plug and/or sperm were observed. Mated females were assigned in an unbiased manner to the control and treatment groups. Pregnant rats were treated bwith the test item (mixed with peanut oil) by gavage at concentrations of 54.2, 2.71 and 0.14 rng/kgbw/day on days 6-15 of pregnancy. Pregnant rats of low-dose group and rnid-dose group showed no toxic symptoms, there were no significant difference in body weight and body weight gain compared with that of the control group. On days 13,17 and 20 of gestation, the body weight and body weight gain of high-dose goup were significantly lower than that of control group. There was no difference in the number of pregnant rats dead, mortality, mean uterine weight, mean number of live fetuses, mean number of implanlations, total number of implantations. numbcr and percent of live and dead fetuses and resorptions of treated groups compared to the control froup. Fetuses of treated groups had no abnormal appearance. There was no significant difference in body weights, body length and tail length of fetuses of treated groups cornpared with that of the control. No organ and tissue malformations were observed both in treated and control animals. In conclusion, the test item did not cause any overt embryotoxicity and teratogenicity on rats.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
mouse
Quality of whole database:
Guideline study; Klimisch 2 (non-GLP)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information