Registration Dossier
Registration Dossier
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EC number: 261-235-4 | CAS number: 58398-71-3
Endpoint summary
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 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 calcium magnesium (di)hydroxide oxide by read across.
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 dihydroxide 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 dihydroxide oxide in aqueous media, the substance is obviously void of any genotoxic potential.
Classification for genotoxicity is not warranted.
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