Registration Dossier
Registration Dossier
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EC number: 910-697-1 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
No data for carcinogenicity are available with the substance identified as reaction mass of calcium fluoride (47.5% w/w), calcium sulfate (ca 22.3%) and calcium carbonate (ca 12.09%). However, carcinogenicity studies are available on calcium fluoride (from read-across source NaF) and carcinogenicity study with calcium sulfate or calcium carbonate is not deemed necessary as described below. Two well-documented studies by NTP on rats and mice are available. The NTP concluded that the study provides 'equivocal evidence' for carcinogenicity in male rats, but no such effects were observed for female rats. In the study on mice, there was no evidence of carcinogenicity in either sex. On this basis it has been concluded that CaF2 is not carcinogenic. Consequently, also the reaction mass will not be carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 29.3 mg/kg bw/day
- Study duration:
- chronic
- Species:
- other: rats and mice
- Quality of whole database:
- The NOAEL of the registered substance is based on the NOAEL of Calcium fluoride extrapolated from the NOAEL of sodium fluoride determined in the 2-year carcinogenicity studies conducted in rat and mouse exposed by oral route
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
Harmonised classification
Reaction mass of calcium fluoride and calcium sulfate and calcium carbonate has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification
Based on the information available on its three main constituents, no self-classification is proposed regarding carcinogenicity of the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
