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Key value for chemical safety assessment

Additional information

There is no indication for genotoxic/mutagenic effects of either burnt lime or 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 with respect to DNA breakage. This is applicable to calcium contained in calicum oxide by read across. Finally, calcium is an essential mineral nutrient omnipresent in the human body, with daily dietary requirements for adults of approximately 1000 mg (calcium), varying by developmental status and age.

The results of in vitro gene mutation studies in bacteria, in vitro chromosome aberration studies in mammalian cells and in vitro gene mutation studies in mammalian cells performed using calcium carbonate were all negative. It is concluded that both calcium oxide and calcium carbonate are not genotoxic and neither chemical nor mixtures of these chemicals warrants classification for mutagenicity under CLP.

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 calcium oxide in aqueous media, CaO is obviously void of any genotoxic potential. Classification for genotoxicity is not warranted.

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