Registration Dossier
Registration Dossier
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EC number: 270-337-8 | CAS number: 68425-17-2
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
The read-across substances were not acutely toxic to Daphnia magna when tested according to OECD guideline 202 (Daphnia sp. Acute Immobilisation Test). Sorbitol was determined to possess a 48-hour EC50 in Daphnia of >973 mg/L (active ingredient) and Maltitol was determined to possess a 48-hour EC50 in Daphnia of >1020 mg/L (active ingredient).
Key value for chemical safety assessment
Additional information
Metabolic data demonstrate that the notifiable substance, as well as the read-across substances [maltose, maltitol, sorbitol, wheat glucose syrup (WGS), and dextrin] share a common metabolic pathway as they are converted to D-glucose and/or sorbitol via hydrolysis of their glycosidic linkages by the intestinal brush border carbohydrases. On the basis of their common mono- and disaccharide metabolites, the properties of the notifiable substance, is expected to be similar to the read-across substances maltose, sorbitol, maltitol, WGS and dextrin. Considering this, it is anticipated that exposure to any of the aforementioned saccharides would ultimately result in the formation of D-glucose and/or sorbitol. As such, maltose, sorbitol, maltitol, WGS, and dextrin may be used as appropriate surrogates for the notifiable substance, considering their common metabolic products.
Two studies addressing short-term toxicity to aquatic invertebrates are presented in the dossier.
RA Sorbitol Short-term toxicity to aquatic invertebrates – daphnia - 2005: Acute toxicity to Daphnia magna was assessed according to OECD guideline 202 (Daphnia sp. Acute Immobilisation Test) and in accordance with GLP. Daphnia were exposed under semi-static conditions to the substance for 48 hours. Temperature was maintained at 20 ± 1°C and the concentrations were measured at 0 and 24 hours. The number of immobile daphnids was recorded at 24 and 48 hours. The 48-hour EC50 for immobility was determined to be >1390 mg/L (test substance) or >973 mg/L (active ingredient).
RA Maltitol Short-term toxicity to aquatic invertebrates – daphnia - 2005: Acute toxicity to Daphnia magna was assessed according to OECD guideline 202 (Daphnia sp. Acute Immobilisation Test) and in accordance with GLP. Daphnia were exposed under semi-static conditions to the substance for 48 hours. Temperature was maintained at 20 ± 1°C and the concentrations were measured at 0 and 24 hours. The number of immobile daphnids was recorded at 24 and 48 hours. The 48-hour EC50 for Immobility was determined to be >1450 mg/L (test substance) or >1020 mg/L (active ingredient).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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