Registration Dossier
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EC number: 900-501-2 | CAS number: -
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
48 h, EC50 (Daphnia magna): > 100 mg/L; read-across
Key value for chemical safety assessment
Additional information
No data 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 aquatic invertebrates. In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5, the assessment was, therefore, based on a study conducted with one of the main constituents isomaltulose (CAS No. 13718-94-0).
This key study was carried out as a limit test according to OECD Guideline 202 and GLP (Juckeland, 2013). The test organism Daphnia magna was exposed to the test substance in a static system at the nominal test concentration of 100 mg/L. As no immobilisation was observed during the study, the EC50 was determined to be > 100 mg/L.
The second main constituent trehalulose (CAS No. 51411-23-5) is structurally very similar to isomaltulose. Both are heterodisaccharides formed by the glycosidic linkage of glucose and fructose, an α-1,6-glycosidic linkage in the case of isomaltulose and an α-1,1-glycosidic linkage in the case of trehalulose. As the difference of the linkage is not expected to significantly influence the toxicological potential of the substance, the study conducted with isomaltulose is considered to be representative for trehalulose as well. The remaining 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, i.e. 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.
The available study conducted with isomaltulose is thus considered sufficient, in order to confirm the assumption of low 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 aquatic invertebrates.
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