Registration Dossier
Registration Dossier
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EC number: 231-820-9 | CAS number: 7757-82-6
Endpoint summary
Administrative data
Description of key information
Sodium sulphate did not show skin irritating properties and showed slight irritation to eyes.
Skin Rabbit in vivo test result: Not irritating
Eye Rabbit in vivo test result: Not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin
In a GLP compliant skin irritation study according to OECD Guideline 404, 3 HC:NZW rabbits were exposed to 500 mg sodium sulphate for 4 hours. The vehicle was polyethyleneglycol 400 and the coverage was occlusive. The post exposure period was 14 days. No signs of irritation were observed (Bayer, 1991).
Eye
In a GLP compliant eye irritation study according to OECD Guideline 405 and EU Method B.5, 3 HC:NZW rabbits had 90 mg sodium sulphate instilled in one eye. The duration of treatment was 24 hours and the post exposure time was 21 days. The conjunctivae showed slight irritation after 48 hours (score was 1), which was fully reversible within 7 days. No chemosis and no cornea and iris irritation were observed. The overall irritation score was 1.3 (Bayer, 1991).
Justification for classification or non-classification
Sodium sulphate was not a skin irritant in a well conducted study. It is a slight eye irritant with redness of the conjunctiva observed. The redness was reversible within 7 days. Sodium sulphate should not be classified as irritating substance for skin and eye based on Rabbit in vivo test results.
Based on the irritation scores in skin and eye irritation studies, sodium sulphate does not need to be classified for skin and eye irritation according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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