Mutagenicity and genotoxicity of ClearTaste.

Abstract

The present study investigates whether ClearTaste is mutagenic/genotoxic by employing it as a test article in bacterial reverse mutation (Ames test) and in vitro human peripheral blood lymphocyte micronucleus assays conducted by a Good Laboratory Practice certified third party as parameterized by the United States Food and Drug Administration. ClearTaste is a taste modulator derived from the filtrate of submerged Cordyceps sinensis and is typically processed into a powder. It functions as a bitter, sour, astringency, metallic and lingering aftertaste mitigator/blocker. The Ames test includes revertant colony counts almost exclusively less than 100/plate and significantly fewer ClearTaste counts as opposed to known mutagen counts. The micronucleus assay reported cytotoxicity exclusively < 25% for doses up to 2,000 μg/L with Cytokinesis Block Proliferation Indices less than water and statistically significant differences between micronucelated cells post dosing compared to cyclophosphamide and vinblastine controls. The conclusion of these data is that ClearTaste is neither muta- nor carcinogenic.