Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
- Justification for type of information:
- According to "Guidance on information requirements and chemical safety assessment Chapter R.5: Adaptation of information requirements, section R.5.1.3, the exposure is not significant.
Data source
Materials and methods
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Females in any group fed the CE-2 diet showed neither abnormal condition after parturition nor any severe lesions in the kidney. These data show that the combination of corn oil and diet with a particular constitution may cause adverse effects on the renal tubules in pregnant and/or lactating rats, suggesting that corn oil gavage as a vehicle can be a confounding factor in the reproductive toxicity studies, depending on the diet.
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