Registration Dossier
Registration Dossier
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EC number: 212-391-7 | CAS number: 813-94-5
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 arguments is based on,
(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 calcium dicitrate is not expected to impair fertility.
(2) 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.
(3) 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 calcium 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 calcium dicitrate canbe 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 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 774 mg/kg (bw) expressed as tri calcium dicitrate.
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 > 311 mg tri calcium dicitrate /kg bw); rats (NAOEL > 295 mg citric acid/kg, equivalent NOAEL > 381 mg tri calcium dicitrate /kg bw); rabbits (NAOEL > 425 mg citric acid/kg, equivalent to NOAEL > 548 mg tri calcium dicitrate /kg bw) and hamsters (NAOEL > 272 mg citric acid/kg, equivalent to NOAEL > 351 mg tri calcium dicitrate /kg bw)
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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