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Key value for chemical safety assessment

Additional information

Calcium lactate fully dissociates into Ca2+ ions and lactate- under aqueous and/or physiological conditions.

The genotoxicity potential of calcium lactate can be understood in terms of the genotoxicity potential of calcium chloride and lactic acid.

Lactic acid is a ubiquitous and essential molecule of life in all higher animals and many micro-organisms. It is found in a multitude of food components. For such a molecule the determination of any genotoxic effect is irrelevant, since the internal exposure, and to a lesser extent the external exposure to this molecule is fixed and unavoidable.

Calcium chloride was negative in the bacterial mutation tests and the mammalian chromosome aberration test, showing no genotoxic potential for calcium chloride.

In addition, calcium chloride is already present in the tissue culture media of thein vitrotest systems for genetic toxicity testing, and needed for normal function of the cells in culture. Testing calcium chloride in vitro will affect the cellular homeostasis due to osmolarity and/or pH of the culture medium which might give rise to non-specific effects. Considering these aspects and taken into account that calcium chloride is a normal constituent of the body, no further genotoxicity testing is considered necessary.

Short description of key information:
Calcium lactate fully dissociates into Ca2+ ions and lactate. The toxicological effects of calcium lactate can be understood in terms of the toxicological effect of lactic acid and calcium chloride. Both substances are not genotoxic.

Lactic acid is not genotoxic; however this finding is scientifically irrelevant.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the above provided information, classification of calcium lactate is not warranted in accordance with Directive 67/548/EEC and EU (CLP) Regulation (EC) No. 1272/2008.

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