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
Read across from a fairly limited reliable report of a non-standard oral feeding study using citric acid in the rat, conducted without GLP compliance, identified 5-day NOAEL values in the rat of 4000 mg/kg bw/day (which corresponds to 5160 mg tri calcium dicitrate/kg (bw)/d*). (Hoffman, 1976; rel 2) In addition read across from a fairly limited reliable report of a non-standard 10 day feeding study using citric acid conducted without GLP compliance in mice and rats, identified 10-day NOAEL values in the mouse of 1000 and 4000 g/kg bw/day, (which corresponds to 1290 and 5160 mg tri calcium dicitrate /kg (bw)/d*)respectively.
* based on a conversion factor of 1.29 obtained by: (Mass of one mole of salt)/(mass of citric acid produced when tricalcium dicitrate dissociates) = 498.4 / (2 * 192.9) = 1.29.
Key value for chemical safety assessment
Additional information
In accordance with Annex 11, Section 1 of REACH, the endpoint has been waived based on the following information:
(1) The available read across repeat dose toxicity studies with citric acidin their diet reported no treatment related abnormalities.
(2) The low acute toxicity of citric acid LD50 = 5.4g/kg
(3) A long history of human exposure to citric acid and its derived salts.
In conclusion, the available read across data from citric acid, is sufficient to fulfil 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 test organisms exposure will be to the citrate and the metal ions separately.
Therefore, the hazard assessment fortri calcium dicitrate canbe based on the properties of citric acid. All of which are sufficient to fulfil the requirements for long term repeat dose toxicity.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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