Registration Dossier
Registration Dossier
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EC number: 231-915-5 | CAS number: 7778-80-5
Endpoint summary
Administrative data
Description of key information
An in vitro human skin irritation study according to the EU guideline, performed with Potassium sulfate (containing 15% KHSO4) does not show irritation.
An in vivo eye irritation study according to OECD guideline 405 with potassium sulphate 99% pure is not irritating in rabbits. Additionally an in vitro eye irritation study according to OECD guideline 437 with potassium sulphate containing 15% KHSO4, is severely irritating in bovine cornea.
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
For skin irritation an in vitro test with human skin according to EU guideline B46 and draft OECD guidelines with potassium sulphate (containing 15% KHSO4) shows no irritation.
An in vivo eye irritation study in rabbits performed according to OECD
405 shows that potassium sulphate (99% pure) is not irritating. Although
some irritation was observed in the first 24 hours, this was in most
animals reversible within 48 hours. Two animals showed some redness
(score 1) up to 7 days after expsoure, but reversible within 14 days.
However, potassium sulphate containing 15% KHSO4 has been shown severely
irritating for the eye in an in vitro eye irritation test with bovine
cornea. This study was performed according to OECD guideline 437.
Justification for classification or non-classification
With regard to skin irritation potassium sulphate (with or without 15% of impurity KHSO4) does not have to be classified according to Directive 67/548/EC nor according to the CLP Directive.
Potassium sulphate does not have to be classified for eye irritation.
However, in case potassium sulfate contains the impurity KHSO4 its
contents need to be taken into account for classification towards eye
irritation/eye damage.
Potassium sulphate containing 15% of KHSO4 does need to be classified as
Xi, R41 Risk of serious damage to eyes according to Directive 67/548/EC
and as Cat.1, H318 Causes serious eye damage according to the CLP
Directive.
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.
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