Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

There is no indication for genotoxic/mutagenic effects of either “Reaction mass of Limestone and dicalcium silicate” or any other calcium salts in the available in vitro studies. Furthermore, supportive information is available from comet assays on Ca(OH)2-containing endodontic materials, provided in section 7.12 of the technical dossier (Ribeiro, 2004; Ribeiro, 2005; da Silva, 2007): The results were invariably negative withn respect to DNA breakage. This is applicable to “Reaction mass of limestone and dicalcium silicate”by read across.

“Reaction mass of Limestone and dicalcium silicate”does not contain any main constituents or major impurities that are known to be genotoxic. Finally, calcium is an essential mineral nutrient omnipresent in the human body, with daily dietary requirements for adults of approximately 1000 mg, varying by developmental status and age.

Short description of key information:
“Reaction mass of Limestone and dicalcium silicate” is not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In view of the omnipresence and essentiality of Ca and of the physiological non-relevance of any pH shift induced by“Reaction mass of Limestone and dicalcium silicate” in aqueous media, the substance is obviously void of any genotoxic potential. Classification for genotoxicity is therefore not applied.