Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: 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.

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