Registration Dossier
Registration Dossier
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EC number: 231-598-3 | CAS number: 7647-14-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No information available
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).
Reproductive toxicity studies were not performed on sodium chloride, due to the ubiquitous human exposures (oral and dermal) to NaCl without causally related reproductive effects, animal testing is not necessary. 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.
Exposure Aspects: The contact of humans to sodium chloride due to handling in or at the workplace may involve incidental dermal exposure, which is controlled by skin protection measures. The systemic exposure to sodium chloride caused by such incidental skin contact is judged to be irrelevant compared to the daily intake and the accepted exposure during swimming in the sea.
Short description of key information:
Sodium chloride is not classified as a reproductive toxicant.
Effects on developmental toxicity
Description of key information
Sodium chloride is not classified as a developmental toxicant.
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).
Developmental toxicity studies were not performed on sodium chloride, as pregnant women typically consume several grams of salt per day (oral exposure) and potentially have dermal exposure to 2-3% NaCl in saltwater when bathing in the ocean. Due to the ubiquitous human exposures to NaCl without causally related developmental effects, animal testing is not necessary. 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.
Exposure Aspects: The contact of humans to sodium chloride due to handling in or at the workplace may involve incidental dermal exposure, which is controlled by skin protection measures. The systemic exposure to sodium chloride caused by such incidental skin contact is judged to be irrelevant compared to the daily intake and the accepted exposure during swimming in the sea.
Toxicity to reproduction: other studies
Additional information
No information available
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
