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Administrative data

Endpoint:
developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

An OECD 422 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening study has been conducted on the substance. No evidence of developmental effects such as deformations was observed; however, effects on reproductive performance were noted. These effects were the reduction in the number of uterine implantations at 330 and 750 mg/kg/day (and as consequence litter size) and were associated with reduced survival. The two females receiving 750 mg/kg/day that were not pregnant had an extended or irregular cycle however there was no link between cycles in the other females and litter size or post-implantation or pup mortality.

Due to the lack of developmental effects in the OECD 422 study, but observations of effects on reproductive performance, an OECD 443 study is considered the most appropriate study for further assessment reproductive effects. Although this study primarily assesses reproductive performance, it should also provide alerts for any developmental effect(s), in the event that such effects were no detected by OECD 422 study.

In conclusion, the conduct of a specific developmental toxicity study such as an OECD 414 study is not considered appropriate at this time from the scientific and also the animal welfare perspective as such a study will use a significant number of animals. Depending upon the outcome of the OECD 443 study, consideration may have to be given to further testing for reproductive effects and if required the need for a developmental study will be revisited at this time.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion