Genotoxicity and Mutagenicity of Commercial-Grade Sucralose: No Concerns in Modern Bioassays.

Sucralose is a no-calorie sweetener that has been consumed globally for decades. Previously, numerous studies, including a standard battery of genetic toxicity and carcinogenicity studies, demonstrated that sucralose poses no genotoxicity and carcinogenicity concerns. To further substantiate its safety, a series of genetic toxicity studies were conducted in accordance with Organisation for Economic Co-operation and Development test guidelines and Good Laboratory Practice, including a bacterial reverse mutation assay, in vitro and in vivo micronucleus assays, an in vivo comet assay, a Muta™Mouse transgenic rodent assay, and the ToxTracker assay. Sucralose showed no genotoxic potential in the bacterial reverse mutation and in vitro micronucleus assays. In the in vivo micronucleus assay, no increase in the frequency of micronucleated cells was observed. The results of the ToxTracker test showed no evidence of genotoxic potential. Although the in vivo comet assay showed evidence of DNA damage in several tissues, the results were complicated by low tail intensities in the controls, borderline results in various samples, and non-normal distributions of hedgehogs in both treated and control groups. In the transgenic rodent assay, sucralose did not increase rates of mutation in the lacZ transgene. The results of these studies demonstrate that commercial-grade sucralose is non-genotoxic.