Lack of potential carcinogenicity for aspartame – Systematic evaluation and integration of mechanistic data into the totality of the evidence. (January 2020)

• Record Type: Journal Article
• Authors: Wikoff, D.S.; Chappell, G.A.; Fitch, S.; Doepker, C.L.; Borghoff, S.J.
• Is Part Of: Food and chemical toxicology. Volume 135(2020)
• Publication Date: 2020-01
• Subjects: Aspartame -- Sweetener -- Carcinogenicity -- Key characteristic of carcinogen -- Mechanistic -- Systematic; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2019.110866
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: Despite repeated confirmation of aspartame safety in a variety of foods and beverages, there continues to be interest in researching the potential carcinogenic risk associated with its consumption. The objective of this evaluation was to conduct a systematic assessment of available mechanistic data using a framework for quantitatively integrating the key characteristics of carcinogens (KCCs). For aspartame, 1332 endpoints were appraised for quality and relevance and quantitatively integrated using an algorithm to determine the potential for individual KCC activity based on all available evidence, and subsequently assessed in the context of human and animal evidence streams. An overall lack of activity (integrated scores <0 and no "strong" categorizations) was observed for all KCCs except oxidative stressor (#5), for which activity was determined to be unlikely to be related to a carcinogenic response. Overall, the KCC-based analysis, together with the lack of consistent evidence of carcinogenicity in experimental animals, continue to support lack of carcinogenicity from aspartame consumption. This comprehensive evaluation of available mechanistic data demonstrates the need for a systematic approach to identify and appraise all avaialble data as part of weight-of-evidence determinations related use of KCC in evaluations of potential human carcinogenicity. Highlights: Systematically identified, appraised, and integrated mechanistic data in an assessment of potential carcinogenicity of aspartame. Evaluated 1332 endpoints related to the key characteristics of carcinogens reported in the literature, study reports, and HTS. Observed overall lack of activity related to carcinogenicity, no KCC activity found to be "strong". Overall findings continue to support lack of carcinogenicity from aspartame consumption. Lack of mechanistic activity in human models should address remaining uncertainties around potential human carcinogenicity.