Registration Dossier
Registration Dossier
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EC number: 211-185-4 | CAS number: 632-79-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The NOEL in the TBPA pilot prenatal developmental study in the rat was 3000 mg/kg. The NOEL for TCPA in the rat prenatal developmental study was 1000 mg/kg. The NOEL for reproductive organs in rats and mice of TCPA after 13 weeks administration was 1500 mg/kg.
The NOEL in the TBPA pilot prenatal developmental study in the rat was 3000 mg/kg. The NOEL for TCPA in the rat prenatal developmental study was 1000 mg/kg. The NOEL for reproductive organs in rats and mice of TCPA after 13 weeks administration was 1500 mg/kg.
Short description of key information:
TBPA: pilot prenatal developmental in the rat.
TCPA (tetrachlorophthalic anhydride): rat prenatal developmental, rat and mouse 13 week studies with additional investigation of sperm morphology and vaginal cytology.
Effects on developmental toxicity
Description of key information
TBPA: pilot prenatal developmental in the rat.
TCPA (tetrachlorophthalic anhydride): rat prenatal developmental, rat and mouse 13 week studies with additional investigation of sperm morphology and vaginal cytology.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The NOEL in the TBPA pilot prenatal developmental study in the rat was 3000 mg/kg. The NOEL for TCPA in the rat prenatal developmental study was 1000 mg/kg. The NOEL for reproductive organs in rats and mice of TCPA after 13 weeks administration was 1500 mg/kg.
Toxicity to reproduction: other studies
Additional information
The combination of data on reproductive organs from subchronic studies in two species and prenatal developmental studies indicate TBPA and TCPA do not affect reproduciton.
Justification for classification or non-classification
The lack of effects on the reproductive organs and in prenatal developmental studies in more than one species for TBPA or TCPA indicates the substance is not a reproductive toxicant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
