Registration Dossier
Registration Dossier
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EC number: 242-734-6 | CAS number: 18996-35-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
In accordance with Annex 11, Section 1 of REACH, the waiving argument is based on,
(1) Reproduction: Screening data from a 90 week feeding study using citric acid together with repeat dose studies using both sodium citrate and citric acid indicate a lack of treatment related effects on the reproductive organs. Based on this it is concluded thatsodium dihydrogen citrateis 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 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 forsodium dihydrogen citratecanbe based on the properties of citric acid. All of which are sufficient to fulfil the requirements for this endpoint.Short description of key information:
Read across data from a 90 week 1.2 % (about 600 mg/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 666 mg/kg (bw) expressed as tri sodium citrate. The value is derived by using (using MW(sodium dihydrogen citrate)/MW(citric acid) = 214/192.9 = 1.11)
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/kg, equivalent to NOAEL > 268 mg/kg sodium dihydrogen citrate); rats (NAOEL > 295 mg/kg, equivalent NOAEL > 327 mg/kg sodium dihydrogen citrate); rabbits (NAOEL > 425 mg/kg, equivalent to NOAEL > 472 mg/kg sodium dihydrogen citrate) and hamsters (NAOEL > 272 mg/kg, equivalent to NOAEL > 302 mg/kg sodium dihydrogen citrate)
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.
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