Reaction mass of 1-O-α-D-glucopyranosyl-D-fructose and 6-O-α-D-glucopyranosyl-D-fructose and fructose and glucose and sucrose

Toxicity to microorganisms

Description of key information

Based on all available related information, no toxicity to microorganisms is expected.

Additional information

No data are available on the toxicity of Reaction mass of 1-O-α-D-glucopyranosyl-D-fructose and 6-O-α-D-glucopyranosyl-D-fructose and fructose and glucose and sucrose to microorganisms. However based on the intrinsic properties of the constituents, toxicity to microorganisms is not expected. Additionally, a study conducted with the structurally similar substance sodium gluconate (CAS No. 527-07-1) is used to support the assessment, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5.

Based on the molecular structure of the constituents, and their natural occurrence and role in common metabolic pathways, toxic effects on aquatic organisms are not to be expected. Reaction mass of 1-O-α-D-glucopyranosyl-D-fructose and 6-O-α-D-glucopyranosyl-D-fructose and fructose and glucose and sucrose is the aqueous solution (syrup) of the reaction mass of isomaltulose (CAS 13718-94-0), trehalulose (CAS 51411-23-5), fructose (CAS 57-48-7), glucose (CAS 50-99-7), sucrose (CAS 57-50-1), isomaltose (CAS 499-40-1) and oligosaccharides.

Fructose and glucose are common monosaccharides that feed into glycolysis. Glycolysis is a well described metabolic pathway used by virtually all cells, both eukaryotic and prokaryotic, to produce energy in form of ATP. Sucrose is a disaccharide formed by the glycosidic linkage of glucose and fructose. It can be cleaved into its component monosaccharides by the enzyme sucrase (Berg, Tymoczko and Stryer, 2002). Glucose, fructose and sucrose are included in Annex IV of Regulation 1907/2006/EC, as sufficient information is known about these substances, and they are considered to cause minimum risk because of their intrinsic properties. Isomaltulose is a disaccharide composed of α-1,6-linked glucose and fructose, naturally occurring in honey and sugar cane juice. As sucrose, isomaltose is cleaved to fructose and glucose by disaccharidases, and the monosacharides are metabolised following the same classical routes (Lina, Jonker and Kozianowski, 2002; and references therein). Trehalulose is the 1,1-linked glucosylfructose isomer of sucrose (1,2-linked glucosylfructose). It is expected to be hydrolysed to glucose and fructose by disaccharidases, which are ubiquitous among organisms in nature.

The study available for the structurally similar substance sodium gluconate (CAS No. 527-07-1) was conducted according to the guideline DIN 38412 L8 with Pseudomonas putida as test organism, and the EC0 was determined to be > 5000 mg/L. Although the study does not fully comply with today's standards, it supports the assumption that Reaction mass of 1-O-α-D-glucopyranosyl-D-fructose and 6-O-α-D-glucopyranosyl-D-fructose and fructose and glucose and sucrose is not inhibitory to microorganisms.

The information available on the constituents of Reaction mass of 1-O-α-D-glucopyranosyl-D-fructose and 6-O-α-D-glucopyranosyl-D-fructose and fructose and glucose and sucrose, together with the study conducted with sodium gluconate, are considered to be sufficient evidence on the lack of toxicity of Reaction mass of 1-O-α-D-glucopyranosyl-D-fructose and 6-O-α-D-glucopyranosyl-D-fructose and fructose and glucose and sucrose towards microorganisms. Further testing is thus not deemed necessary.