Registration Dossier
Registration Dossier
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EC number: 478-310-4 | CAS number: 53803-13-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In an OECD 421 Reproductive Toxicity Screening guideline study, 96 Sprague-Dawley (SD) rats of 61-65 days old were randomly assigned to four groups with 12 rats per sex in each group. The test item was administered daily by gavage in doses of 0, 4.9 mg, 9.8 mg and 19.6 mg/(kg bw.d).
The average litter weight and body weight, the sex ratio (m/f) of pups at birth, the average litter weight and body weight, the average litter weight gain and body weight gain, the sex ratio (m/f), the survival rate, the incidence of appearance deformity, small stature and subcutaneous ecchymosis of pups on the 4th day after delivery showed no significant differences compared with the solvent control group (p>0.05).
There were no significant differences in offspring loss before implantation, after implantation or after the birth compared with the solvent control group (p>0.05).
No histological changes occurred on testis and epididymis of male rats and ovary and uterus of female rats in the high dose groups.
No reproductive and developmental toxicity was observed under the experimental conditions.
Justification for classification or non-classification
Additional information
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