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Description of key information

A fairly limited reliable report of a non-standard oral feeding study using tri sodium 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. (Bächtold 1978; rel 2)  In addition a fairly limited reliable report of a non-standard study using tri sodium citrate conducted without GLP compliance, identified 10-day NOAEL and LOAEL values in the mouse of 4 and 8 g/kg bw/day, respectively. (Bächtold 1978; rel 2). Data from a 150 day oral feeding study where rats were given up to 7.7% as sodium 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, the study on repeated dose toxicity does not need to be conducted as there is sufficient information on the long term toxicity of trisodium citrate, based on,

 

(1) The available read across repeat dose toxicity studies with tri sodium citratein their diet which reported no treatment related abnormalities.

(2) The 150 day repeat dose toxicity study in rats which reported no abnormalities up to a dose of 7.7% as sodium citrate.

 (3) A long history of human exposure to citric acid and its derived salts.

 

In conclusion, the repeat dose study using tri sodium citrate 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 fortri sodium citrate 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