Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

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.

 

Based on the read-across substances, Sorbitol and Maltitol, the substance is predicted to possess a 96-hour LC50 in freshwater fish of >1000 mg/L; a 48 hour EC50 in aquatic invertebrates of > 973 mg/L; and a 72-hour EC50 and NOEC (based on growth rate and biomass) in aquatic algae and cyanobacteria of >994 mg/L. This substance is not considered to be acutely toxic to fish, or aquatic invertebrates, nor is it considered to be toxic to aquatic algae or cyanobacteria. Although information on the substance or read-across substances was not available for microorganisms, based on studies in glucose and maltose, in accordance with section 1 of Annex XI, the activated sludge respiration inhibition test (required in Annex VIII section 9.1.4) does not need to be conducted as it is scientifically reasonable to expect that the notifiable substance will not significantly inhibit activated sludge respiration.

 

The requirement to present data for endpoints on fish early life stage toxicity test, fish short term toxicity test on embryo and sac-fry, fish juvenile growth test, long term toxicity to aquatic invertebrates, sediment toxicity, and short- and long-term toxicity to invertebrates (terrestrial) is not proposed by the registrant.