Registration Dossier
Registration Dossier
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EC number: 206-074-2 | CAS number: 299-27-4
Carcinogenicity
Administrative data
Description of key information
Considering that gluconate is an endogenously occurring compound that is utilized by the body in a normal physiological process, studies addressing the mutagenicity/genotoxicity of gluconate are not deemed necessary as it is expected that the compound is not carcinogenic.
Key value for chemical safety assessment
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
In accordance with section 1 of REACH (REGULATION (EC) No 1907/2006) Annex XI, the carcinogenicity study (required in section 8.9.1) does not need to be conducted as there is sufficient weight of evidence from several independent sources of information leading to the conclusion that the substance is not carcinogenic.
Gluconate is an oxidative metabolite of glucose best known to occur in microorganisms, but also occurring in mammals (Rezzi, et al., 2009). Glucose is oxidized to gluconate by glucose 1-dehydrogenase, which occurs in mammalian tissues (Harrison, 1931; Harrison, 1932). Gluconate enters the pentose phosphate pathway via conversion to 6-phosphogluconate, a metabolic route of glucose catabolism. The formation of 6-phosphogluconate from exogenous gluconate has been demonstrated in mammals, demonstrating mammalian enzymatic capabilities for metabolizing gluconate (Stetten & Topper, 1953; Leder, 1957; Hakim & Moss, 1974; Casazza & Veech, 1986). Gluconokinase is the enzyme responsible for catalyzing the phosphorylation of gluconate to 6-phosphogluconate and has been identified in mammalian tissues, such as the brain and kidneys (Hakim & Moss, 1974). Thus, gluconate occurs endogenously from the oxidative metabolism of glucose and is utilized in a well-known biochemical pathway (the pentose phosphate pathway) of glucose catabolsim via the action of gluconokinase. Considering that gluconate is an endogenously occurring compound that is utilized by the body in a normal physiological process, studies addressing the mutagenicity/genotoxicity of gluconate are not deemed necessary as it is expected that the compound is not carcinogenic.
Reference List:
Casazza, J. & Veech, R., 1986. The interdependence of glycolytic and pentose cycle intermediates in ad libitum fed rats. J Biol chem, 261(2), pp. 690-698.
Gumaa, K., Greenslade, K. & McLean, P., 1968. Enzymes and intermediates of the pentose phosphate pathway in liver hepatomas. Biochim Biophys Acta, 158(2), pp. 300-302.
Hakim, A. & Moss, G., 1974. The effect of ether anesthesia on cerebral glucose metabolism - The pentose phosphate pathway. Anesthesiology, 34(3), pp. 261-267.
Hakim, A., Moss, G. & Gollomp, S., 1976. The effect of hypoxia on the pentose phosphate pathway in brain. J Neurochem, 26(4), pp. 683-688.
Harrison, D., 1931. Glucose dehydrogenase: a new oxidising enzyme from animal tissues. Biochem J, 25(4), pp. 1016-1027.
Harrison, D., 1932. The product of the oxidation of glucose by glucose dehydrogenase. Biochem J, 26(4), pp. 1295-1299.
Herken, H., Meyer-Estorf, G., Halbhübner, K. & Loos, D., 1976. Spastic paresis after 6-aminonicotinamide: metabolic disorders in the spinal cord and electromyographically recorded changes in the hind limbs of rats. Naunyn Schmiedebergs Arch Pharmacol, 293(3), pp. 245-255.
Kolbe, H., Keller, K., Lange, K. & Herken, H., 1976. Metabolic consequences of drug-induced inhibition of the pentose phosphate pathway n neuroblastoma and glioma cells. Biochem Biophys Res Commun, 73(2), pp. 378-382.
Leder, I., 1957. Hog kidney gluconokinase. J Biol chem, Volume 255, pp. 125-136.
Rezzi, S. et al., 2009. Metabolic shifts due to long-term caloric restrion revealed in nonhuman primates. Exp Gerontol, 44(5), pp. 356-372.
Stetten, M. & Stetten, D., 1950. The metabolism of gluconic acid. J Biol Chem, 187(1), pp. 241-252.
Stetten, M. & Topper, Y., 1953. Pathways from gluconic acid to glucose in vivo. J Biol chem, Volume 203, pp. 653-664.
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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