Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

An Ames test was conducted to examine the mutagenic potential of the isomaltulose greens. Salmonella typhimurium strains TA1535, TA102, TA100, TA98, and TA97a, were exposed to concentrations of 62, 185, 556, 1667, and 5000 ug/plate of test substance in solvent in both the presence and absence of S9. No treatment cultures showed mutation frequencies significantly greater than negative controls. Positive controls showed significantly greater mutation frequencies over negative controls, therefore the test was valid. The test substance is not mutagenic in either the presence or absence of metabolic activation.

In a second mutation study, the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation. Therefore, Isomaltulose Solution is considered to be non-mutagenic in this mouse lymphoma assay.

In a third mutagenicity study the test item did not induce structural chromosomal aberrations as determined by the chromosome aberration test in human lymphocytes in vitro. Therefore the test item is considered to be non-clastogenic in this chromosome aberration test when tested up to 5 mg/mL in the absence and presence of metabolic activation.

Isomaltulose greens is not mugatenic.

Short description of key information:
Isomaltulose greens was tested for genetic toxicity using the standard Ames test and in vitro gene mutations assay. Both studies were negative with respect to mutations both with and without activation. Isomaltulose greens is not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

A series of in vitro genetic toxicity studies demonstrated that isomaltulose greens is not mutagenic. Therefore, isomaltulose greens is not classified for mutagenicity.