Registration Dossier

Administrative data

Description of key information

The acute oral LD50 to rats is greater than 3550 mg/kg (95% fiducial limits 3040 - 4140), the acute dermal LD50 to rabbits is 10000 mg/kg and the acute inhalation LC50 to rats is greater than 42 mg/l (42000 mg/m3)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 550 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
42 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Additional information

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.

Both the acute dermal and inhalation studies appear to be conducted prior to guidelines and GLP. The acute dermal LD50 to rabbits is greater than 10000 mg/kg and the acute inhalation LC50 to rats is greater than 42 mg/l (> 42000 mg/m3). Also, the dermal and the inhalation routes are not likely to be the routes of exposure.

Justification for classification or non-classification

Sodium chloride is not formally classified in the EU (according to Regulation EC No. 1272/2008 Annex VI, Table 3.1 and Regulation EC No. 1272/2008 Annex VI, Table 3.2), however according to the UN-GHS, sodium chloride would be classified as Acute Oral Cat. 5 and not classified for the acute dermal and acute inhalation.