Registration Dossier
Registration Dossier
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EC number: 238-523-3 | CAS number: 14516-71-3
Endpoint summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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