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Key value for chemical safety assessment

Effects on fertility

Additional information
Short description of key information:
Read across data from a 90 week 1.2 % (about 600 mg citric acid/kg (bw)/day) dietary supplement feeding study with citric acid reported no effects on either the number of young born to mice and rats or their subsequent survival up to the point of weaning. (Bonting et al 1956) This would correspond to 954 mg/kg* (bw) expressed as tri potassium citrate.

In addition, read across data from a reliable study by the Food & Drug Research Laboratories (1973) reported no citric acid related teratogenic effects in any of the species tested. For mice - NAOEL > 241 mg citric acid/kg, equivalent to NOAEL > 383 mg tri potassium citrate /kg bw); rats (NAOEL > 295 mg citric acid/kg, equivalent NOAEL > 470* mg tri potassium citrate /kg bw); rabbits (NAOEL > 425 mg citric acid/kg, equivalent to NOAEL > 676* mg tri potassium citrate /kg bw) and hamsters (NAOEL > 272 mg citric acid/kg, equivalent to NOAEL > 432* mg tri potassium citrate /kg bw)

* 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)

Effects on developmental toxicity

Additional information

In accordance with Annex 11, Section 1 of REACH, the toxicity to reproduction testing requirements have been waived has been waived based on the following information:

 

(1) Reproduction:  Read across screening data from a 90 week feeding study using citric acid indicate a lack of treatment related effects on the reproductive organs. Based on this it is concluded that tri potassium citrate  is not expected to impair fertility. Developmental effects: Read across data from a reliable citric acid feeding study in rats, mice, rabbits and hamsters did not report any treatment related developmental effects at the highest doses tested. 

 

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

 

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 this endpoint.

Justification for classification or non-classification