Registration Dossier
Registration Dossier
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EC number: 910-697-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No study is available on the registered substance. However, reliable studies performed on its three main constituents are available. The reaction mass of calcium fluoride and calcium sulfate and calcium carbonate is not considered to be mutagenic or clastogenic, as those effects were also absent for the 3 main constituents CaCO3, CaF2 and CaSO4.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No in vivo study is available on the substance. However, reliable studies have been performed on CaSO4 and CaF2 (read-across from NaF). No evidence of clastogenicity, even at dose levels causing severe toxicity, in a well-conducted mouse study performed with sodium fluoride in which chromosomal aberrations and micronucleus formation was assessed. In a reliable OECD guideline study (NIER 2002) calcium sulfate dihydrate showed negative results in the micronucleus test in vivo up to the test concentration of 5000 mg/kg bw.
Therefore, the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate is not considered to be clastogenic.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
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 available studies performed on its three main constituents, no additional classification is proposed regarding genetic toxicity 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).
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