Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

screening for reproductive / developmental toxicity
Data waiving:
other justification
Justification for data waiving:
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