Registration Dossier

Administrative data

Description of key information

The key study for acute oral toxicity was read across from zinc dicitrate, which report an LD50 value of 5400mg/kg (Roche, 1981; rel 2). [PLACEHOLDER FOR DERMAL TOX READ ACROSS]. Data for the acute toxicity inhalation endpoint was waived, since reliable data was available for the acute oral and dermal endpoints. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 400 mg/kg bw

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 citric acid. The LD50 for citric acid acute oral toxicity is >5400 mg/kg, which is equivalent to 5400 * 1.59 = 8586 mg/kg tripotassium citrate (using MW(tripotassium citrate)/MW(citric acid) = 306.4/192.9 = 1.59.

Justification for classification or non-classification

Based on the available information, no classification or labelling is required for tripotassium citrate in accordance with the current EU regulations.