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Administrative data

Description of key information

Chronic administration at doses of 4% sodium chloride in the diet over a period of 2 years induced elevated blood pressure in the rats. This dose can be considered as an excessive exposure.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
LOAEL
2 533 mg/kg bw/day
Study duration:
chronic
Species:
rat

Additional information

Repeated dose oral:

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).

The estimated fatal dose of sodium chloride is approximately 0.75 to 3.00 g/kg (HSDB - Hazard Substance Data Bank - 750 to 3000 mg/kg). The lowest toxic dose (TDLo) for an adult man with normal blood pressure is 8200 mg/kg (Patty's Handbook of Toxicology, 5th Ed.; Vol. 3, 375). High oral sodium chloride intake is associated with increased risk of hypertension; however, this is a well studied field in humans and additional animal testing data would not add value. Based on the studies, sodium chloride is not classified for any repeated dose effects.

The LOEL from the key study identified a dose level of < 4% via the diet and the calculated LOEL would be 2533 mg/kg/day.

Repeated dose dermal:

Over and above the consumption of salt, humans (including pregnant women) have the potential to have a a dermal exposure to 2 -3% sodium chloride in saltwater when bathing in the ocean. Due to the ubiquitous human exposure to sodium chloride without causally any effects, animal testing is not necessary.

Repeated dose inhalation:

The toxicity of sodium chloride is so low that only mild nasal irritation is experienced by drillers in salt mines even when dust levels exceed the nuisance dust ACGIH TLV of 10 mg/cu m. The main systemic effect of excess sodium chloride intake is on blood pressure elevation. Due to the ubiquitous human exposure to sodium chloride without causally any effects, animal testing is not necessary.

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) and UN-GHS