Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-755-5 | CAS number: 866-84-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional 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
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
