Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No study with potassium sulphate is available. However, several other studies with substances from the sulfate category are present. In a skin sensitisation study (LLNA) with magnesium sulphate itself, according to OECD 429, EU B.42 and OPPTS 870.2600 it was shown that the substance is not sensitising. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted in any of the animals. As magnesium sulphate and potassium sulphate are both in the inorganic sulfate category, potassium sulphate is also considered to be not sensitising.

Migrated from Short description of key information:
No study with potassium sulphate itself is available. However, a study with magnesium sulpate is present showing no sensitisation in a LLNA study. Therefore, potassium sulphate is also considered not sensitising.

Justification for classification or non-classification

According to Directive 67/548/EC and the CLP Directive no classification of potassium sulphate for sensitisation is required based on the data present.