Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

Calcium sulfate has been shown to be non-genotoxic both in vitro and in vivo.  These observations indicate that calcium sulfate is not expected to be a genotoxic carcinogen. Calcium sulfate  has been examined in repeat dose oral studies and has shown low levels of toxicity. There is sufficient data to indicate that calcium sulfate does not pose a risk of carcinogenicity.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

There are no lifetime animal studies available on calcium sulfate in order to directly investigate for possible carcinogenic activity. However, calcium sulfate gave negative results in the in vitro and in vivo genotoxicity studies. In repeat dose studies with calcium sulfate there is no evidence that calcium sulfate is able to induce hyperplasia or pre-neoplastic lesions.

Justification for classification or non-classification

No classification is warranted under CLP for carcinogenicity based on evidence from genotoxicity and repeat dose studies.