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Long-term toxicity to fish

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Description of key information

30 d, ChV (fish): 15237 mg/L (ECOSAR v1.00)

Key value for chemical safety assessment

Additional information

According to the “Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance”, long-term testing should be proposed if the chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 indicates the need to investigate further the effects on aquatic organisms. Based on all information available, this is not the case for Reaction mass of 1-O-α-D-glucopyranosyl-D-fructose and 6-O-α-D-glucopyranosyl-D-fructose and fructose and glucose and sucrose.

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.

QSAR calculations for long-term fish toxicity were performed for all main 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, resulting in chronic values above 10000 mg/L (ECOSAR v1.00).

Moreover, based on ready biodegradability studies available for isomaltulose, trehalulose and palatinose syrup (consists mainly of glucose, fructose and sucrose), 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 expected to be rapidly degraded in the environment. As the constituents also have low adsorption potential (log Koc 1) to sediment or suspended particles, long-term exposure of aquatic organisms is unlikely.

Additionally, short-term toxicity data available for the structurally similar substance sodium gluconate (CAS No. 527-07-1) indicate no hazard potential to fish (EC50 > 10000 mg/L).

Based on all 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 the acute fish toxicity data available for the structural analogue sodium gluconate (CAS No. 527-07-1), 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 expected to have long-term effects on fish. Therefore, and for reasons of animal welfare, long-term testing of fish is not considered justified.

 

References:

Berg, Tymoczko and Stryer, 2002, Biochemistry (5thed.) W.H. Freeman and Company

Lina, Jonker and Kozianowski, 2002, Isomaltulose (Palatinose ®): a review of biological and toxicological studies. Food and Chemical Toxicology 40, 1375-1381

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