Registration Dossier
Registration Dossier
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EC number: 231-665-7 | CAS number: 7681-38-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
In view of the acidic reaction to be expected upon dissociation of sodium hydrogensulfite in aqueous media, partial read-across needs to be considered to sulfuric acid, as outlined below. However, the applicability is somewhat restricted since during the gastric passage, an acidic pH (1-2) is already established under normal physiological conditions. Concerning inhalation particle size considerations render solid, commercially available sodium hydrogensulfate as practically unavailable via the inhalation route. Finally, dermal absorption and thus dermal toxicity may be considered negligible. For all other aspects, read-across to sodium sulfate is taken into account in the absence of data specifically for sodium hydrogensulfate.
No data on acute or long-term toxicity of sodium hydrogensulfate are available, thus justified read-across to sodium sulfate and sulfuric acid is performed. Occupational exposure of general population/consumer to sodium hydrogensulfate via inhalation or dermal route is not expected due to the physical and chemical properties (large particle size, low dustiness, inorganic compound).
Sodium sulfate:
Occupational Exposure
Sodium sulphate can exist as dust (by-product) during manufacturing of various chemicals. Occupational exposure to sodium sulphate is possible by dermal contact and inhalation of the dust.
The occupational exposure limit value (OEL) is determined at 10 mg/m3 for an 8 hour exposure
Conclusion and classification:
Sodium sulfate is not toxic to the human. It is a naturally occuring substance which is reduced in the sulfur cycle.
Sodium sulfate does not need to be classsified for human hazards.
Based on read-across from data on sodium sulfate, it is concluded that sodium hydrogensulfate also lacks any toxic potential, and the substance therefore does not require classification for human hazards according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and subsequent regulations.
.General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
In view of the acidic reaction to be expected upon dissociation of sodium hydrogensulfite in aqueous media, partial read-across needs to be considered to sulfuric acid, as outlined below. However, the applicability is somewhat restricted since during the gastric passage, an acidic pH (1-2) is already established under normal physiological conditions. Concerning inhalation particle size considerations render solid, commercially available sodium hydrogensulfate as practically unavailable via the inhalation route. Finally, dermal absorption and thus dermal toxicity may be considered negligible. For all other aspects, read-across to sodium sulfate is taken into account in the absence of data specifically for sodium hydrogensulfate.
No data on acute or long-term toxicity of sodium hydrogensulfate are available, thus justified read-across to sodium sulfate and sulfuric acid is performed. Occupational exposure of general population/consumer to sodium hydrogensulfate via inhalation or dermal route is not expected due to the physical and chemical properties (large particle size, low dustiness, inorganic compound).
Sodium sulfate:
Consumer Exposure
Exposure to sodium sulfate occurs via drinking water and through naturally occurring amounts in foodstuffs. In drinking water (wells) concentrations up to 2 g/l were measured in theUSA. The taste threshold for sodium sulfate is 250 – 900 mg/l. The maximum acceptable concentration for drinking water is 200 – 500 mg/l sulfate, and is based on taste (Ministry of Environment, Lands and Parks Province of British Columbia, Canada, 2000).
No data on the sulfate content of foodstuffs were found; however, according to WHO, sulfates are used as additives in the food industry and the estimated average daily intake of sulfate in food in the USA is 453 mg/person, based on data on food consumption and reported usage of sulfates as additives (WHO, 2003).An Acceptable Daily Intake for sodium sulfate has not been established.
Potential exposure to consumers also occurs from the use of detergents.
WHO/FAO did not set an ADI for sodium sulfate, since they consider this to be a substance of no concern. This was re-confirmed in the joint WHO/FAO meeting of June 2001.
Conclusion and classification:
Sodium sulfate is not toxic to the human. It is a naturally occuring substance which is reduced in the sulfur cycle.
Sodium sulfate does not need to be classsified for human hazards.
Based on read-across from data on sodium sulfate, it is concluded that sodium hydrogensulfate also lacks any toxic potential, and the substance therefore does not require classification for human hazards according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008and subsequent regulations.
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