Registration Dossier
Registration Dossier
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EC number: 242-734-6 | CAS number: 18996-35-5
Endpoint summary
Administrative data
Description of key information
A fairly limited reliable report of a non-standard oral feeding study using sodium dihydrogen citrate in the rat, conducted without GLP compliance, identified 10-day NOAEL and LOAEL values in the rat of 8 and 16 g/kg bw/day, respectively. (Bachtold 1978; rel 2) In addition a fairly limited reliable report of a non-standard study using sodium dihydrogen citrate conducted without GLP compliance, identified 10-day NOAEL and LOAEL values in the mouse of 4 and 8 g/kg bw/day, respectively. Data from a 150 day oral feeding study where rats were given up to 7.7% as sodium dihydrogen citrate in their diet reported no abnormalities. (Packman et al 1963; rel 4)
Key value for chemical safety assessment
Additional information
In accordance with Annex 11, Section 1 of REACH, this endpoint has been waived based on the following information,
(1) The available repeat dose toxicity studies. For example, a reliable ten daysodium dihydrogen citratefeeding study in rats gave NAOEL value of 8000 mg/kg (Bachtold, 1978); a reliable 10 daysodium dihydrogen citratefeeding study in mice gave a NOAEL value of 4000 mg/kg respectively (Bachtold, 1978).A 150 day study where RATS were fed up to 7.7 % as sodium dihydrogen citrate in their diet reported no abnormalities.In addition, read across data from various citric acid repeat dose oral studies provides no indication of any treatment related effects.
(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 repeat dose data from sodium dihydrogen citrate, combined with read-across 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 sodium 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 for sodium dihydrogencitrate canalso be 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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