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

Short-term toxicity to fish

Description of key information

96 h, LC50 (fish): 186000 mg/L (ECOSAR v1.00)

Additional information

No studies are available on the short-term 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 fish. However, 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 also expected to be hydrolysed to glucose and fructose by disaccharidases, which are ubiquitous within organisms in nature.

Additionally, an acute fish toxicity study is available for the structurally similar substance sodium gluconate (CAS No. 527-07-1), with a LC50 of > 10000 mg/L. As this study has some methodological deficiencies and the test substance may not properly represent all constituents of Palatec M, QSAR calculations for all constituents were also used for the assessment. The estimated values LC50 1.86E05 - 8.68E07 mg/L obtained for the constituents further support the low toxicity of the substance.

With all 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, and for reasons of animal welfare, further testing on fish is not considered justified.