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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 6360 mg tri potassium citrate/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 1590 and 6360 mg tri potassium citrate/kg (bw)/d*)respectively.
* Note, the value is derived by using a conversion factor of 1.59 (using MW (tri potassium citrate)/MW (citric acid) = 306/192.9 = 1.59)

Key value for chemical safety assessment

Additional information

In accordance with Annex 11, Section 1 of REACH, the repeat dose toxicity endpoints have 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 potassium 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 potassium 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