Registration Dossier
Registration Dossier
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EC number: 908-700-6 | CAS number: 64519-82-0
Endpoint summary
Administrative data
Description of key information
Additional information
No studies are available on the biodegradation of Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol, i.e. Isomalt in water. However, QSAR predictions for both of the main components, i.e. 1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-glucitol (=6-O-α-D-glucopyranosyl-D-sorbitol) (1,6-GPS) as well as data available for the read-across substance Isomaltulose (=6-O-alpha-D-glucopyranosyl-D-fructose) indicate that Isomalt is expected to be rapidly degraded by microorganisms in the environment. Hydrolysis is not expected to be a main degradation pathway of the substance based on the molecular structure of the components of Isomalt and on the ready biodegradability of the substance. Isomalt has a low potential for bioaccumulation and adsorption to soil and sediment due to low log Kow values in the range of -4.2 to -3.7.
Concerning the environmental fate of the substance, it has additionally been evaluated using the OECD QSAR Toolbox v4.2 by means of the set of profilers relevant for environmental fate endpoints. These results are presented as supporting information. The chemical structure of the substance (smile codes) was used as input parameter for the evaluation. The sugar alcohols in both of the disaccharides are isomers of each other and the prediction is therefore the same for both components of Isomalt. Table 1 summarized the profilers and their output for E-fate relevant endpoints.
Table 1: OECD QSAR Toolbox profiling for E-fate relevant endpoints.
Endpoint |
Relevant Profilers |
OECD QSAR Toolbox Output |
Bioaccumulation: Aquatic |
BCF (upper trophic) |
-0.049 log(L/kg bdwt) |
Bioaccumulation metabolism half-lives |
Very fast |
|
Biodegradation |
Biodegradation primary (Biowin 4) |
hours - days |
Biodegradation probability (Biowin 1) |
Biodegrades Fast |
|
Biodegradation probability (Biowin 2) |
Biodegrades Fast |
|
Biodegradation probability (Biowin 5) |
Biodegrades Fast |
|
Biodegradation probability (Biowin 6) |
Biodegrades Fast |
|
Biodegradation probability (Biowin 7) |
Biodegrades Fast |
|
Biodegradation ultimate (Biowin 3) |
days - weeks |
|
Bioaccumulation/Biodegradation (PBT) |
Example Prioritization Scheme (PBT) |
not B|not P |
The OECD QSAR Toolbox results support the available QSAR and read across data on biodegradation (Biowin profilers) showing that the substance biodegrade fasts. Furthermore, the profilers “BCF (upper trophic)” and “Bioaccumulation metabolism half-lives” verify that the substance is not expected to bioaccumulate in aquatic organisms.
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