Registration Dossier
Registration Dossier
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EC number: 204-171-4 | CAS number: 117-08-8
Endpoint summary
Administrative data
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
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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