Mutagenicity and genotoxicity studies of aspartame

Regul Toxicol Pharmacol. 2019 Apr:103:345-351. doi: 10.1016/j.yrtph.2018.01.023. Epub 2018 Feb 19.


Two studies were conducted to further assess its mutagenic and genotoxic potential. In a bacterial reverse mutation pre-incubation study, Salmonella typhimurium strains TA100, TA1535, TA98, and TA1537 and Escherichia coli WP2 uvrA were treated with aspartame at concentrations of up to 5000 μg/plate with or without metabolic activation and showed no mutagenic potential. Similarly, in vivo micronucleus testing of aspartame following gavage administration (500-2000 mg/kg body weight) to Crlj:CD1(ICR) strain SPF male mice showed no increase in the proportion of micronucleated polychromatic erythrocytes in bone marrow cells collected and evaluated 24 or 48 h post administration. Overall, aspartame had no potential for mutagenic or genotoxic activity.

Keywords: Aspartame; Genotoxicity; Micronucleus; Mutagenicity.

Publication types

  • Review

MeSH terms

  • Administration, Oral
  • Animals
  • Aspartame / administration & dosage
  • Aspartame / toxicity*
  • Humans
  • Mice
  • Mice, Inbred ICR
  • Mutagenicity Tests
  • Mutagens / administration & dosage
  • Mutagens / toxicity*
  • Sweetening Agents / administration & dosage
  • Sweetening Agents / toxicity*


  • Mutagens
  • Sweetening Agents
  • Aspartame