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Key value for chemical safety assessment

Additional information

Sodium lactate fully dissociates into Na+ions and lactate-in aqueous solutions and/or under physiological conditions.

The toxicology of sodium lactate can be understood in terms of the toxicology of lactic acid and sodium chloride (see read across statement).

Lactic acid is an 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.

Historically, sodium chloride (as a major ingredient in edible salt) has been commonly used in cooking and as a condiment and food preservative. Sodium chloride is categorised under GRAS (Generally Recognised as Safe) by the FDA (U.S. Food and Drug Administration) and the average daily levels of sodium intake for adults range from 2 to 5 grams. A technical report by WHO and the Food and Agriculture Organization (FAO) recommended the consumption of less than 5 grams sodium chloride (or 2 grams sodium) per day as a population nutrient intake goal, while ensuring that the salt is iodized (WHO, 2003).

Although ambiguous results were noted, by and large Sodium chloride was reported to be negative in the AMES test. The positive responses so observed does not have any relevance to handling and safety. Hence, sodium chloride was not classified as genotoxic.

Base on the above information sodium lactate is not genotoxic.


Short description of key information:
Lactic acid and sodium chloride are not considered to be genotoxic. Since the genotoxicity potential of sodium lactate will be assessed with information on the genotoxicity potential of lactic acid and sodium chloride, sodium lactate is not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Lactic acid and sodium chloride are not considered to be genotoxic. Since the toxicology of sodium lactate can be understood in terms of the toxicology of lactic acid and sodium chloride, sodium lactate is not genotoxic. No classification is required.