Genotoxicity Evaluation of Wood-Derived and Vegetable Oil-Derived Stanol Esters

Plant stanol esters from wood and vegetable oil sources were tested for genotoxicity in bacterial (Salmonella typhimurium) and mammalian cell (L5178Y) gene mutation assays and in a mammalian cell chromosome aberration assay (CHO cells). The two stanol ester formulations were tested separately at doses up to the limit of solubility, with and without the addition of an Aroclor-induced rat liver microsome metabolic activation system (S9 mix). All tests were performed in duplicate and gave negative results for both wood and vegetable oil stanol ester formulations. Thus, plant stanol esters are not genotoxic under the conditions of exposure tested.