Registration Dossier
Registration Dossier
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EC number: 234-448-5 | CAS number: 12004-14-7
Carcinogenicity
Administrative data
Description of key information
Data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13).
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
Justification for classification or non-classification
No classification is warranted under DSD or CLP for carcinogenicity based on evidence from genotoxicity and repeat dose studies.
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.
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