Registration Dossier

Diss Factsheets

Administrative data

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

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.