title: Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale.
abstract: Regulatory authorities worldwide have found the nonnutritive sweetener, sucralose, to be noncarcinogenic, based on a range of studies. A review of these and other studies found through a comprehensive search of electronic databases, using appropriate key terms, was conducted and results of that review are reported here. An overview of the types of studies relied upon by regulatory agencies to assess carcinogenicity potential is also provided as context. Physiochemical and pharmacokinetic/toxicokinetic studies confirm stability under conditions of use and reveal no metabolites of carcinogenic potential. In vitro and in vivo assays reveal no confirmed genotoxic activity. Long-term carcinogenicity studies in animal models provide no evidence of carcinogenic potential for sucralose. In studies in healthy adults, sucralose was well-tolerated and without evidence of toxicity or other changes that might suggest a potential for carcinogenic effects. In summary, sucralose does not demonstrate carcinogenic activity even when exposure levels are several orders of magnitude greater than the range of anticipated daily ingestion levels.
authors.affiliation: a Emeritus Professor of Pathology, Queen Mary University of London , London , UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Berry
authors.affiliation: b Consulting Toxicologist , Richmond , Virginia , USA.
authors.forename: David
authors.initials: D
authors.lastname: Brusick
authors.affiliation: c Department of Pathology and Microbiology , Havlik-Wall Professor of Oncology, University of Nebraska Medical Center , Omaha , Nebraska , USA.
authors.forename: Samuel M
authors.initials: SM
authors.lastname: Cohen
authors.affiliation: d Experimental Pathology Laboratories, Inc. , Durham , North Carolina , USA.
authors.forename: Jerry F
authors.initials: JF
authors.lastname: Hardisty
authors.affiliation: e Director and R&D Fellow, Medical Affairs, Johnson & Johnson Consumer Inc. , Fort Washington , PA , USA.
authors.forename: V Lee
authors.initials: VL
authors.lastname: Grotz
authors.affiliation: f Department of Pathology , New York Medical College , Valhalla , New York , USA.
authors.forename: Gary M
authors.initials: GM
authors.lastname: Williams
mesh_terms: D000818:Animals; D015197:Carcinogenicity Tests / Q000379:methods*; D002273:Carcinogens / Q000633:toxicity*; D005503:Food Additives / Q000009:adverse effects / Q000633:toxicity; D006801:Humans; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods; D013395:Sucrose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000737:chemistry / Q000493:pharmacokinetics; D013549:Sweetening Agents / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000633:toxicity; D014018:Tissue Distribution; D036401:Toxicity Tests, Chronic / Q000379:methods
chemical_list: D002273:Carcinogens; D005503:Food Additives; D013549:Sweetening Agents; D013395:Sucrose; C026285:trichlorosucrose