Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-638-8 | CAS number: -
Table 1. Fertility and Reproductive parameters Parental generation
No. females evaluated
Mean precoital time (days)
Number of pregnant dams
Fertility index (%)
No. dams with pups (live + dead)
Gestation length (days)
No. dams with live pups
Gestation Index (%)
No. Implantation sites (total)
No. Implantation sites (mean)
Number of pups at birth (total)
Number of pups at birth (mean)
Birth Index (mean %)
Birth Index (total %)
Number of stillbirths
No. of dams with stillborn pups
Number of live born pups (total)
Number of live born pups (mean)
Live birth index (mean %)
Live birth index (total %)
Pre-implantation loss (mean %)
Pre-implantation loss (total %)
Post-implantation loss (mean %)
Post-implantation loss (total %)
1 p≤0.05 Chi2-test
2 p≤0.01 Chi2-test
* p≤0.05 Fisher test
**p≤0.01 Fisher test
v p≤0.05 Dunnett test or Student’s t-test
vvp≤0.01 Dunnett test or Student’s t-test
ap< 0.05 Chi2-test
#: Animal no. 71 was excluded, because of its premature death on gestation day 9
The aim of the study was to obtain information on possible effects of the test item on general toxicity, reproduction and/or development according to OECD guideline 422. The test item was administered orally to rats at dose levels of 60, 120 or 300 mg test item/kg bw/day. The application started two weeks before mating on test day one and ended on the day or one day before sacrifice. Day of sacrifice was on test day 43 for the male rats and on lactation day 4 or shortly thereafter for the female rats.
Effects on the parental generation (general toxicity) :
One of 10 male and one of 10 female animals of the high dose group (300 mg test item/kg bw/day) died prematurely on test day 33 or on gestation day 9 (TD 26). Slight to moderate salivation was noted in a few male and female animals of the inter-mediate dose group (120 mg test item/kg bw/day) on 1 day each, which was regarded as test item-related. In the high dose group (300 mg test item/kg bw/day) piloerection and a slight to extreme salivation was noted for several to all male and female animals on several days and regarded as test item-related. A statistically significant reduction in body weight was noted for the male animals of the intermediate dose group (120 mg test item/kg bw/day) and for both sexes at the high dose group (300 mg test item/kg bw/day).
Statistically significant increases in the activity of ALAT and/or aP and ASAT and decreases in the globulin, cholesterol, chloride and potassium concentrations were noted for the male and/or female animals of the intermediate and/or the high dose group (120 and/or 300 mg test item/kg bw/day).
Statistically significant changes were noted for several organ weights of the male and female animals of the intermediate and the high dose group (120 and 300 mg test item/kg bw/day), most remarkable for the thymus and liver weights of the animals of the high dose group.
Macroscopic inspection at autopsy revealed test item-related changes in the stomachs of male and female animals of the intermediate and high dose group (120 and 300 mg test item/kg bw/day).
Histopathological examination of the organs from animals of the high dose group (300 mg test item/kg bw/day) revealed test item-related changes in the liver (hepatocellular hypertrophy and macrovesicular vacuolation evoked by fatty change) and the non-glandular stomach (squamous cell hyperplasia) of male and female animals.
The high number of 5 pregnant dams with a total loss of implantation sites in the high dose group (300 mg test item/kg bw/day) led to a statistically significant reduction in the gestation index, in the mean number of implantation sites per dam, in the mean number of born pups per dam and in the birth index. Accordingly, the implantation loss index was statistically significantly increased in the high dose group.
The high percentage of stillbirths led to a statistically significantly reduced live birth index in the high dose group (300 mg test item/kg bw/day). Test item related effects were also noted on the pups from the 3 remaining dams of the high dose group (300 mg test item/kg bw/day), expressed by a statistically significantly reduced survival rate during the lactation period, a statistically significant reduction in the mean litter weight and in the total litter weight per dam on lactation day 1 and 4.
The following no-observed adverse-effect levels were established:
Paternal and Maternal toxicity: NOAEL= 60 mg/kg b.w./day, p.o.
Reproductive toxicity: NOAEL=120 mg/kg b.w./day, p.o.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again