Registration Dossier
Registration Dossier
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EC number: 231-598-3 | CAS number: 7647-14-5
Carcinogenicity
Administrative data
Description of key information
Sodium chloride is not classified as a carcinogen
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LOAEL
- 2 533 mg/kg bw/day
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.
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).
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.
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 as a carcinogen.
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