Genotoxicity and subchronic toxicity studies with heated olestra

Olestra is a class of sucrose-fatty acid polyesters intended for use as a non-caloric replacement of edible oil. Genotoxicity and subchronic toxicity studies were conducted to determine whether olestra could form genotoxic or toxic breakdown products during simulated commercial use. Heated olestra was prepared for these studies by batch-frying potato slices in olestra at 177–185°C for 25–32 hr over 5–7 days. Genotoxicity of this previously heated olestra was assessed in four standard in vitro assays: (1) Salmonella mutagenesis (Ames test); (2) forward mutagenesis of mouse lymphoma cells at the thymidine kinase locus; (3) unscheduled DNA synthesis in rat hepatocytes; and (4) clastogenicity in cultured Chinese hamster ovary cells. These tests were conducted with previously heated olestra at concentrations up to at least 5 mg/ml both in the absence of exogenous bioactivation and, for assays (1), (2) and (4) with added liver microsomal (S-9) activation. The Ames and mouse lymphoma assays were performed with olestra (10 mg/ml and 23 mg/litre, respectively) either alone or emulsified with the non-toxic, non-ionic surfactant Pluronics F68, both in the presence and absence of metabolic activation. To test for clastogenicity in vivo, rats were administered previously heated olestra by gavage at 5 g/kg per day for up to 5 days and bone marrow cells were examined for chromosomal aberrations. Heated olestra lacked genotoxic activity detectable by the aforementioned assays. Heated olestra was fed to Fischer 344 rats at up to 10% of the diet (w/w) for 91 days. Evaluation of survival, food consumption, feed efficiency, physical condition, body weight, organ weight, haematological and clinical chemistry parameters, and histomorphology revealed no adverse effects attributable to ingestion of heated olestra at exposure levels in excess of those anticipated for human consumption. It is concluded that olestra used as a deep-frying medium conveys no genotoxic or toxic hazard at anticipated levels of human consumption.