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Key value for chemical safety assessment

Effects on fertility

Description of key information
no data
Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 500 mg/kg bw/day
Additional information

In the repeated-dose toxicity study, male and female Fischer 344 rats were administered Tetrachlorophthalic anhydride (CASRN 117-08-8) at 0, 94, 375, 750 or 1500 mg/kg-bw/day No effects on the reproductive organs and parameters evaluated (sperm morphology, sperm density, proportion of motile sperm and vaginal cytology) were observed at any dose tested.

In the repeated-dose toxicity study described previously, B6C3F1 mice were administered Tetrachlorophthalic anhydride (CASRN 117-08-8) at 0, 94, 375 or 1500 mg/kg-bw/day. No effects on the reproductive organs and parameters evaluated (sperm morphology, sperm density, proportion of motile sperm and vaginal cytology) were observedat any dose tested.

Short description of key information:

Toxicology studies were conducted by administering TCPA by oral gavage to F344/N rats and B6C3F1 mice for 13 weeks. Evaluations included histopathology, clinical pathology, and analyses of reproductive system parameters. Additionally the results of a Prenatal Developmental Toxicity Study according OECD Guideline 414 was published by EPA cited from U.S. Environmental Protection Agency September, 2010, Hazard Characterization Document SCREENING-LEVEL HAZARD CHARACTERIZATION 4,5,6,7-Tetrachloro-1,3-isobenzofurandione (CASRN 117-08-8).

Effects on developmental toxicity

Description of key information

Pregnant Sprague-Dawley rats (24 mated females/dose) were administered Tetrachlorophthalic anhydride (CASRN 117-08-8) in corn oil via gavage at 0, 250, 1000 or 2000 mg/kg-bw/day during gestation days 6 – 19. One-half of the fetuses per litter were examined for skeletal malformations while the other half were examined for internal anomalies.

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

No maternal toxicity, embryotoxicity, fetotoxicity or teratogenic effects were observed at or below 1000 mg/kg/d.

Toxicity to reproduction: other studies

Additional information

no data

Justification for classification or non-classification

Due to the results of the fertility and developmental study (no effects at or below 1000 mg/kg/d) a classification is not justified