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Description of key 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.  Sodium chloride and lactic acid are both practically non-toxic by the oral, and dermal route. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Higher than 2000 mg/kg bw.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Inhalation is not considered to be the most relevant route of exposure.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Higher than 2000 mg/kg bw.

Additional information

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

The toxicology of sodium lactate can be understood in terms of the toxicology of lactic acid and sodium chloride. Sodium chloride and lactic acid are both practically non-toxic by the oral, inhalation and dermal route. Lactic acid is irritating to abraded rabbit skin; however, such local effects related to the pH are not relevant for sodium lactate.

Lactic acid is a ubiquitous and essential biological molecule. It is, as is to be expected, practically non-toxic by all routes of exposure. Dermal exposure to 2000 mg/kg bw induced severe irritation, but no mortality. Oral administration of doses of 3500 mg/kg bw induce mortality, and lower doses induce clear signs of toxicity. All toxicity signs clearly point to (acid) irritation as the main or only mode of action. At 7400 mg/m3 lactic acid in air, one out of 5 female rats died in a 4 hour inhalation study. All symptoms observed in dead and surviving animals suggest (acid) irritation as the main or only mode of action. Nonetheless, local effects such as irritation are not relevant for the lactate, and are caused due to the low pH.

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, the studies were conducted prior to guidelines and GLP, the acute oral LD50 value to rats is > 3550 mg/kg with 95% fiducial limits of 3040 - 4140 mg/kg body weight, all these studies were conducted using a 20 -25% solution of sodium chloride in water.

The dermal studies appear to be conducted prior to guidelines and GLP. The acute dermal LD50 to rabbits is greater than 10000 mg/kg. No additional studies are considered necessary.

Inhalation is not considered as the most relevant exposure route for sodium lactate. Since data are available for the oral and dermal route, such a study does not need to be conducted.


Justification for selection of acute toxicity – oral endpoint
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. Sodium chloride and lactic acid are both practically non-toxic with oral LD50s higher than 2000 mg/kg bw.

Justification for selection of acute toxicity – dermal endpoint
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. Sodium chloride and lactic acid are both practically non-toxic with dermal LD50s higher than 2000 mg/m3.

Justification for classification or non-classification

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

The acute toxicity of sodium lactate can be understood in terms of the toxicology of sodium chloride and lactic acid. The substance is not acutely toxic by the oral and dermal routes of exposure. No classification is required.