Registration Dossier
Registration Dossier
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EC number: 270-337-8 | CAS number: 68425-17-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- 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.
An in vivo skin sensitization study on wheat glucose syrup was identified, which was performed according to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) and in compliance with GLP. Under test conditions the substance has been found to be not a skin sensitizer.
Migrated from Short description of key information:
Results of an in vivo skin sensitization study on the read-across substance wheat glucose syrup performed according to test guidelines have demonstrated that the compound is not a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
There is no information available concerning respiratory or skin sensitisation; data is lacking
Justification for classification or non-classification
Skin sensitization: According to the study run according to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay), the acceptable read-across compound is non-sensitizing.
There is no information available concerning respiratory or skin sensitisation; data is lacking.
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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