Registration Dossier

Administrative data

Description of key information

The key study for acute oral toxicity was read across from citric acid, which reports an LD50 value of 5400mg/kg (Roche, 1981; rel 2). The acute dermal LD50 value was read across from citric acid and reported to be >2000 mg/kg in rat (Safepharm 2006; rel 1). 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
5 400 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 680 mg/kg bw

Additional information

There was no available data for acute toxicity for trisodium 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 sodium 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 trisodium citrate on the properties of citric acid. The LD50 for citric acid is 5400 mg/kg, which is equivalent to 5400 * 1.34 = 7236 mg/kg trisodium citrate (using MW(trisodium citrate/MW(citric acid) = 258.1/192.9=1.34).The same calculations was used to determine the equivalent of the dermal LD50 value of >2000 mg/kg from citric acid for trisodium citrate which is >2680mg/kg.

Justification for classification or non-classification

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