Registration Dossier
Registration Dossier
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EC number: 270-337-8 | CAS number: 68425-17-2
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
Description of key information
Reading across results from Glucose syrups wheat hydrolyzed (WGS), the registered substance is considered to be readily biodegradable on the basis of the results of a well reported, GLP-compliant, guideline ready biodegradability study.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
Metabolic data demonstrate that the notifiable substance (identified under the brand name Lycasin® 80/55), 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, Lycasin® 80/55 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 Lycasin® 80/55, considering their common metabolic products.
The key study is a GLP-compliant, guideline study conducted according to the OECD guideline 301 B on the read-across substance Glucose syrups wheat hydrolyzed (Notox, 2010). Nominal initial test substance concentration was 12 mg/L total organic carbon (TOC). The test was performed using non-adapted activated sludge and the TOC and carbon dioxide (CO2) production were monitored over a 28-day period. The validity criteria were met. The test substance showed degradation (CO2 evolution) of 73 to 81% after 28 days. The reference substance sodium acetate exhibited degradation of 63% after 14 days. The test substance was considered to be readily biodegradable under the conditions of the test.
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