Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key 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.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional 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.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information in the dossier, the substance UV1084 (CAS No. 14516-71-3) does not need to be classified for reproductive toxicity when the criteria outlined in Annex I of 1227/2008/EC are applied based on the weight of evidence from TBBC(CAS No. 96-69-5).

Additional information