Registration Dossier

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.