Registration Dossier
Registration Dossier
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EC number: 206-074-2 | CAS number: 299-27-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
In accordance with column 2 of REACH (REGULATION (EC) No 1907/2006) Annex VIII, the reproductive toxicity study (required in section 8.7.1) does not need to be conducted as a pre-natal developmental toxicity study is available.
Effects on developmental toxicity
Description of key information
Information on the developmental toxicity of potassium gluconate can be obtained by reading across to studies conducted with D-glucono-1,5-lactone. Prenatal development toxicity studies on D-glucono-1,5-lactone in rats and mice (predating GLP) that were equivalent to OECD guideline 414 reported oral NOAELs for developmental toxicity of 594 mg/kg bw/day (rats) and 695 mg/kg bw/day (mice), which were the highest dose levels tested.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 594 mg/kg bw/day
Additional information
Information on the developmental toxicity of potassium gluconate can be obtained by reading across to studies conducted with D-glucono-1,5-lactone. The effects of D-glucono-1,5-lactone were evaluated in a prenatal development toxicity study that was equivalent to OECD test guideline 414 (Report No. FDABF-GRAS-149). This study was conducted prior to the implementation of the GLPs. D-glucono-1,5-lactone was administered by oral gavage to timed-pregnant Wistar rats at dose levels of 0 (water vehicle), 5.94, 27.6, 128.0, or 594.0 mg/kg bw/day (n=21 to 24/group). There were no discernable effects on nidation or on maternal or fetal survival. Also, no evidence of fetotoxicity or teratogenicity were observed. The NOAEL for developmental toxicity in rats was considered to be 594 mg/kg bw/day, the highest dose level evaluated.
The effects of D-glucono-1,5-lactone also were evaluated in a prenatal development toxicity study that was equivalent to OECD test guideline 414 (Report No. FDABF-GRAS-149). This study was conducted prior to the implementation of the GLPs. D-glucono-1,5-lactone was administered by oral gavage to CD-1 mice at dose levels of 0 (water vehicle), 6.95, 32.5, 150.0, or 695.0 mg/kg bw/day (n=21 to 25/group). There were no discernable effects on nidation or on maternal or fetal survival. Also, no evidence of fetotoxicity or teratogenicity was observed. The NOAEL for developmental toxicity in mice was considered to be 695 mg/kg bw/day, the highest dose level evaluated.
D-glucono-δ-lactone is a cyclic ester of gluconic acid which, in aqueous solution, forms an equilibrium mixture of the lactone and gluconic acid. Gluconic acid is a somewhat weak carboxylic acid with a dissociation constant of pKa = 3.6. The dissociation of an acid into a proton and an anion is an equilibrium, the reverse of which is the re-association of that same anion with a proton to reform the original acid. The pKa of 3.6 means that, when the ambient pH = 3.6, half the gluconic acid molecules will exist in the form of the uncharged acid, and half as the anion. At pH < 3.6, the undissociated form will predominate, and pH > 3.6 the anion will predominate. Sodium gluconate and potassium gluconate are both 1:1 salts of gluconic acid, which will each dissolve in water to generate separate sodium or potassium cations and gluconate anions. Sodium and potassium are both strong bases, and are therefore expected to remain ionized at essentially any pH, but the gluconate anions deriving from the salts will be subject to the same equilibrium as those deriving from the free acid. To be in equilibrium, both the forward and the backward reaction must possess the same pKa value, so the gluconate anion is predicted to posses the same pKa of 3.6 as the free acid. In this way, gluconic acid in aqueous solution is in equilibrium with its cyclic esters and its anion, according to the pH of the system, and in any system with sufficient buffering capacity, the effects of introducing equimolar amounts of gluconic acid, D-glucono-δ-lactone, sodium gluconate or potassium gluconate would be indistinguishable. Hence these four substances are considered to be appropriate surrogates for each other in sufficiently buffered aqueous systems, such as environmental waters, flora and fauna.
Justification for classification or non-classification
The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) NO. 1272/2008.
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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