Hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-)

Endpoint summary

Additional information

Casul-Pulver getrocknet (Ettringite) was tested in 2 series in the Bacterial Reverse Mutation Test with the strains TA 1535, TA 97a, TA 98, TA 100, and TA 102 with and without S9 Mix over 48 hours in concentrations from 50 to 5050 µg/plate.

The testarticle was suspended in ddeionised water. None of the concentrations caused a significant increase in the number of revertant colonies. No signs of toxicity towards the bacteria were observed.

The test item Casul-Pulver getrocknet (Ettringite) is not mutagenic in the Bacerial Reverse Mutation Test (Paulus 2010).

As Casul-Pulver getrocknet (Ettringit) was not soluble in water or DMSO an eluate was produced and assessed with respect to its mutagenic potential with and without S9 mix from male rats, treated with phenobarbital/ß-naphthoflavone.

By addition of phytohaemagglutinin human lymphocytes in whole blood culture were stimlated to divide and exposed to the test item for 4 or 22 hours. At the end of the exposure period the cells were spun down by gentle centrifugation for 5 minutes. The supernatant was discarded and the cells were re-suspended and incubated for 22 hours. 3 hours before harvesting 0.1 µg Colcemid/ml was added to the resuspended cell culture. Two independent experiments were performed.

No cytotoxicity or precipitate were observed.

The test item didn't cause any increase of structural chromosome aberrations (Paulus 2010).

Additional information from the registration dossier of CaSO4:

In vitro gene mutation study in bacteria:

In a reliable OECD guideline study (NIER 2001) calcium sulfate dihydrate was tested in a bacterial reverse mutation assay in Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) and Escherichia coli WP2 uvrA with and without metabolic activation (S9). The concentrations tested were12, 37, 111, 333, 1,000 and 3,000 μg/plate. No mutations occurred.

 

In vitro gene mutation study in mammalian cells:

In a reliable OECD guideline study (Flanders 2010) calcium sulfate dihydrate was tested for its abilty to induce mutations in mouse lymphoma L5178Y cells in the presence and absence of metabolic activation. Calcium sulfate dihydrate did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and was therefore considered to be non mutagenic under the conditions of the test.

In vivo micronucleus assay:

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

Short description of key information:
Genotoxicity tests (Ames, HPRT) are negative. Therefore, no further testing of genetic toxicity is neccessary.
Further Data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

It is concluded that the available data indicate that Ettringite has no genotoxicity and therefore does not warrant classification for mutagenicity under DSD or CLP.