Registration Dossier
Registration Dossier
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EC number: 207-439-9 | CAS number: 471-34-1
Carcinogenicity
Administrative data
Description of key information
Uncoated nano calcium carbonate is not expected to pose a risk of carcinogenicity.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No carcinogenicity classification is warranted for uncoated nano calcium carbonate according to CLP based on evidence from genotoxicity, repeat dose studies and long term human studies.
Additional information
There are no lifetime animal studies available on uncoated nano calcium carbonate in order to directly investigate its possible carcinogenic activity. However, uncoated nano calcium carbonate gave negative results in the in vitro genotoxicity studies and in repeat dose studies with uncoated nano calcium carbonate there is no evidence that calcium carbonate is able to induce hyperplasia or pre-neoplastic lesions. Furthermore, the long term human data does not provide any indications of carcinogenicity.
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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