Registration Dossier

Administrative data

Description of key information

The key studies for eye and skin irritation are read across from trisodium citrate, as no high reliability information for the irritation potential of tripotassium citrate was available. Trisodium citrate was found to not be irritating to the skin or the eye or rabbit (Roche, 1995; rel 1), 

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

There was no available data for acute toxicity for tripotassium citrate. However, read across from citric acid and its other salts is sufficient to fill the information requirements for this endpoint. Information available in the public domain on tests carried out on other salts of this metal indicates that the potassium ions are not expected to contribute to the toxicity of the substance. Additionally, the substance will dissociate when in solution, so exposure will be to the citrate and metal ions separately. Therefore it is possible to freely read across from one citrate salt to another salt and conduct the hazard assessment for tripotassium citrate on the properties of trisodium citrate.

Justification for classification or non-classification

Based on the available information read across from trisodium citrate, there is no requirement for classification or labelling of tripotassium citrate for skin or eye irritation, in accordance with current EU guideline.