Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The present target substance, dextransucrase IUBMB, has not been tested but another enzyme (Cellulase, IUBMB has been investigated in the Ames test and in the in vitro chromosome aberration test. Both tests have been performed according to current OECD guidelines, and in compliance with GLP. No evidence for genetic toxicity was observed.

These results are supported by read-across from 2 in vitro gene mutation studies in L5178Y mouse lymphoma cells performed on two different amylases belonging to the class of glycosidases (IUBMB class 3.2.1.). 

The conclusion is that the target substance dextransucrase IUBMB is considered to be non-mutagenic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Due to the lack of genetic toxicity dextransucrase is not classified.