Registration Dossier
Registration Dossier
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EC number: 700-155-0 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
Additional information
In a combined repeated toxicity and screening reproductive toxicity study (OECD 422, GLP) peroxidised corn oil (in olive oil as vehicle) was administered to 12 Wistar rats/sex/dose in by gavage at dose levels of 0 (olive oil), 100, 300 and 1000 mg/kg bw.
Females were treated 14 days before mating, 14 days during mating, 22-24 days during gestation and 4 days during lactation. Males were treated 56 days.
There were no test article-related deaths of animals during the study. All animals lived through observation period without important visible signs of intoxication. The test article was very well tolerated by animals of all dose groups and no sign of systemic toxicity was observed.
No differences in the length of gestation were registered. Decrease of pup’s number in the litter, litter’s body weight, corpora lutea and implantation sites in females of dose group 1000 mg/kg against control group were recorded.
No effects were observed in offsprings up to 1000 mg/kg bw.
Based on the reproduction toxicity, the no observed adverse effect level for female fertility was concluded to be 300 mg.kg-1.
The no observed adverse effect level for male fertility was concluded to be 1000 mg/kg.
The NOAEL for systemic toxicity in males and females was concluded to be 1000 mg/kg bw.
This combined repeated toxicity and screening reproductive toxicity study in the rats is acceptable and satisfies the guideline requirement for a Reproduction screening Toxicity Study (OECD 422) in rats.
Short description of key information:
NOAEL (parental, male) = 1000 mg/kg bw/d
NOAEL (parental, female) = 300 mg/kg bw/d
(OECD 422, rat, oral, GLP)
Effects on developmental toxicity
Description of key information
NOAEL (offspring, screening, external abnormalies) = 1000 mg/kg bw/d
(OECD 422, rat, oral, GLP)
Additional information
See effect on fertility.
Justification for classification or non-classification
Based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, and given the NOAEL at 300 mg/kg bw in females and the NOAEL at 1000 mg/kg bw in males (OECD 422, rat, gavage, GLP), no classification for reproductive and developmental toxicity is warranted according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
Additional information
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