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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

The read-across substances were not acutely toxic to freshwater fish when tested according to OECD guideline 203 (Fish, Acute toxicity test). Sorbitol was determined to possess a 96-hour LC50 in freshwater fish of >1000 mg/L (active ingredient) and Maltitol was determined to possess a 96-hour LC50 in freshwater fish of >1050 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 fish are presented in the dossier. 

RA Sorbitol Short-term toxicity to fish – 2005: Acute toxicity to the freshwater fish Oryzias latipes (Medaka) was assessed in the read-across substance, Sorbitol, according to the OECD guideline 203 (Fish, Acute toxicity test) and in accordance with GLP.  The study was conducted under semi-static conditions with 10 fish per vessel and 1 vessel per concentration for 96 hours. Temperature was maintained at 23.6-24.1°C and the concentrations were measured at 0 and 24 hours. The percentage of dead fish, toxicological symptoms, and abnormalities were recorded at 24, 48, 72 and 96 hours. The following validity criteria were met: dissolved oxygen concentrations remained above 60% of the air saturation value at the end of the test; mortality in the control was not greater than 10%; and the pH of the control and of the test solution did not vary by more than one unit during the course of the test. The LC50 was reported to be >1430 mg/L (test substance) or >1000 mg/L (active ingredient).

 

RA Maltitol Short-term toxicity to fish – 2005: Acute toxicity to the freshwater fish Oryzias latipes (Medaka) was assessed in the read-across substance, Maltitol, according to the OECD guideline 203 (Fish, Acute toxicity test) and in accordance with GLP. The study was conducted under semi-static conditions with 10 fish per vessel and 1 vessel per concentration for 96 hours. Temperature was maintained at 23.6-23.9°C and the concentrations were measured at 0 and 24 hours. The percentage of dead fish, toxicological symptoms, and abnormalities were recorded at 24, 48, 72 and 96 hours. The following validity criteria were met: dissolved oxygen concentrations remained above 60% of the air saturation value at the end of the test; mortality in the control was not greater than 10%; and the pH of the control and of the test solution did not vary by more than one unit during the course of the test. The LC50 was reported to be >1500 mg/L (test substance) or >1050 mg/L (active ingredient).