Registration Dossier

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.

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, a reliable study performed on one of its three main constituents is available and the in vitro studies performed on the main constituents are all negative. 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

Genetic toxicity in vitro

In vitro gene mutation study in bacteria

A key study was identified for each of the three main constituents of the reaction mass substance.

Studies were performed according to the 471 OECD Guideline (Ames Test) on the calcium fluoride (Schulz M. & Landsiedel R., 2010), calcium sulfate dihydrate (NIER, 2001) and on the nano calcium carbonate (Thompson PW, 2010). In these three studies, Salmonella typhimurium strains TA1535, TA100, TA98, TA1537 and in E. coli strain WP2 uvrA were exposed up to 5000 µg/plate, 3000 µg/plate and 5000 µg/plate, of the 3 constituents respectively, with and without metabolic activation (S9). No mutations occurred in any case.

 

In vitro chromosome aberration study in mammalian cells

A key study was identified for two of the three main constituents of the reaction mass substance. Studies were performed according to the 473 OECD Guideline on the calcium fluoride (Hall, 2010) and on the nano calcium carbonate (Lacey FE & Durward R, 2010). Calcium fluoride and carbonate (nano) were tested for their ability to induce structural chromosomal aberrations in cultured V79 cells (chinese hamster lung fibroblasts) or mammalian cells (human lymphocytes), respectively, in the presence and absence of metabolic activation. For both constituents, no statistically significant or biologically relevant increase in the number of cells with chromosomal aberrations was observed, in either the absence or presence of metabolic activation and were therefore considered to be non mutagenic under the conditions of the tests.

 

 

In vitro gene mutation study in mammalian cells

A key study was identified for each of the three main constituents of the reaction mass substance.

Studies were performed according to the 476 OECD Guideline on the calcium fluoride with the HPRT locus method (Wollny, 2010), and on the calcium sulfate dihydrate (Flanders, 2010a) and on the nano calcium carbonate (Flanders, 2010b) with the Mouse Lymphoma Assay. Constituents were tested for their ability to induce mutations in chinese hamster lung fibroblasts (V79 cells) for calcium fluoride, or in mouse lymphoma L5178Y cells for calcium sulfate dihydrate and calcium carbonate (nano) in the presence and absence of metabolic activation. They did not induce any toxicologically significant increases in the mutant frequency at the HPRT locus in V79 cells or at the TK +/- locus in L5178Y cells and were therefore considered to be non mutagenic under the conditions of the tests.

 

 

Genetic toxicity in vivo

In vivo cytogenicity study in mammalian cells

A key study was identified for one of the main constituents of the reaction mass substance.

In a reliable OECD guideline study (NIER 2002) male mice were given 1,250, 2,500 and 5,000 mg/kg bw doses of calcium sulfate dihydrate. Bone marrow was sampled 24h after the last dose and PCE/NCE ratio determined. Calcium sulfate dihydrate showed negative results in the micronucleus test in vivo up to the test concentration of 5000 mg/kg bw.

 

Endpoint Conclusion: No adverse effect observed (negative) in vitro or in vivo for the three main constituents of the substance. Therefore, no adverse effect is expected for the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate.

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).