Registration Dossier
Registration Dossier
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EC number: 212-391-7 | CAS number: 813-94-5
Endpoint summary
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 tricalcium dicitrate. 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 calcium 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 tricalcium citrate on the properties of citric acid. The acute oral LD50 for citric acid is 5400 mg/kg, which is equivalent to 5400*1.29= 6966mg/kg of trcalcium dicitrate. Derived by: (Mass of one mole of salt)/(mass of citric acid produced when tricalcium dicitrate dissociates)=498.4/(2*192.9)=1.29.
Justification for classification or non-classification
Based on the available information, no classification or labelling is required for tricalcium citrate in accordance with the current EU regulations.
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