The absence of genotoxicity of sucralose.
Sucralose is a non-nutritive sweetener that is approximately 600 times sweeter than table sugar. It is currently approved for use in over 80 countries. Evidence from chronic studies demonstrates that this compound is not carcinogenic. This report summarizes the results of genotoxicity studies that were part of the original safety assessment of sucralose-conducted early in the safety investigation and shared with regulatory agencies around the world. Studies included the Ames (Salmonella typhimurium) reverse mutation test, the Escherichia coli pol A+/A- test, an in vitro chromosome damage assay in human lymphocytes, mutation in TK +/- mouse lymphoma cells, an in vivo chromosome aberration test in rats and two separate micronucleus tests in mice. All results were evaluated as negative. These results support the overall conclusion by regulatory and heath agencies that sucralose is safe for its intended use.
Brusick
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Toxicology Consultant, Bumpass, VA 23024, USA. Brusick41@aol.com
Grotz
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Slesinski
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Kruger
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Hayes
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D000818:Animals; D002470:Cell Survival / Q000187:drug effects; D002869:Chromosome Aberrations / Q000139:chemically induced; D004249:DNA Damage; D004926:Escherichia coli / Q000187:drug effects / Q000235:genetics; D005260:Female; D006801:Humans; D007940:Leukemia L5178 / Q000188:drug therapy / Q000201:enzymology / Q000235:genetics; D008214:Lymphocytes / Q000187:drug effects; D008297:Male; D051379:Mice; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D015162:Micronucleus Tests; D009152:Mutagenicity Tests / Q000379:methods*; D009153:Mutagens / Q000145:classification / Q000633:toxicity*; D009154:Mutation; D051381:Rats; D012441:Saccharomyces cerevisiae / Q000187:drug effects / Q000235:genetics; D013395:Sucrose / Q000031:analogs & derivatives* / Q000145:classification / Q000633:toxicity; D013549:Sweetening Agents / Q000145:classification / Q000633:toxicity*; D013937:Thymidine Kinase / Q000235:genetics / Q000378:metabolism
D009153:Mutagens; D013549:Sweetening Agents; D013395:Sucrose; C026285:trichlorosucrose; D013937:Thymidine Kinase