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In accordance with section 1 of REACH (REGULATION (EC) No 1907/2006) Annex XI, the in vitro gene mutation study in mammalian cells (required in section 8.4.3) 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, 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 and Topper, 1953; Leder, 1957; Hakim and Moss, 1971; Casazza and 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 and Moss, 1972). 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 JP, Veech RL (1986). The Interdependence of Glycolytic and Pentose Cycle Intermediates in ad Libitum Fed Rats. J Biol Chem 261(2):690-698.
Gumaa KA, Greenslade KR, McLean P (1968). Enzymes and intermediates of the pentose phosphate pathway in liver hepatomas. Biochim Biophys Acta 15...

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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.