Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

There is no indication for genotoxic/mutagenic effects of either lime or other calcium or magnesium salts in the available in vitro studies. Furthermore, supportive information is available from comet assays on Ca(OH)2-containing endodontic materials, provided in 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.

Finally, calcium and magnesium are essential mineral nutrients omnipresent in the human body, with daily dietary requirements for adults of approximately 1000 mg (calcium) and 220-260 mg (magnesium), varying by developmental status and age.


Short description of key information:
Calcium magnesium carbonate oxide 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 Mg, and of the physiological non-relevance of any pH shift induced by calcium magnesium carbonate oxide in aqueous media, the substance is obviously void of any genotoxic potential.

Classification for genotoxicity is not warranted.