Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
In an oral gavage prenatal developmental toxicity study in rabbits with TBBC, anorexia and spontaneous abortions were observed in dams treated at 20 mg/kg bw/day; the NOAEL for maternal toxicity is 2 mg/kg bw/day (Proctor and Gamble, 1976). Significant decreases in mean pup weight and litter size occurred at 2 mg/kg-day; the NOAEL for developmental toxicity is 0.2 mg/kg bw/day. The Klimisch score of this study was not assignable due to the lack of the identity and purity of the substance and number of animals per dose.

A two-month oral study with TBBC that assessed male reproductive toxicity, decreased sperm production and histopathological changes in seminiferous tubules of rats and mice at 41-57 and 82-99 mg/kg bw/day, respectively (lowest doses tested) were observed (Takahashi and Oishi, 2006). The Klimisch score of this study was not assignable due to the lack of a standard protocol and number of animals per dose.

In the 90 day and 2 year feed studies in rats (F344/n) and mice (B6C3F1) with TBBC, no effects were observed in any reproductive organs. Therefore the toxicity to reproduction (screening) test for UV-1084 is waived.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion