Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

One reliable study (NCI, 1979) is available for phthalic anhydride. Rats and mice were fed for 105 weeks with up to 1000 mg/kg bw/d (rats) and up to 4670 mg/kg bw/day (mice). The mice showed higher NOAELs than the rats but the substance was described to be not carcinogenic in both species. 

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day

Justification for classification or non-classification

Additional information

Carcinogenicity studies were performed with rats and mice using phthalic anhydride. In rats it was not carcinogenic - there were only slightly reduced body weights in male rats at 1000 mg/kg bw/d to be found. In mice non-neoplastic effects were observed at all doses but were not considered to be treatment related. Increased incidences of lung and kidney lymphocytosis, adrenal atrophy and

mineralization of the thalamus were found and the NOAELs stated 4670 mg/kg bw/d in males and 3430 mg/kg bw/d in females. No evidence of carcinogenicity was determined.