ToxStrategies scientists assess carcinogenicity of non-nutritive sweetener, acesulfame K

A recently published article by ToxStrategies scientists presents the systematic identification, appraisal, and integration of mechanistic data in an assessment of the potential carcinogenicity of the non-nutritive sweetener acesulfame K (Ace K). Based on the evaluation of more than 800 measurements/assay endpoints related to one or more key characteristics of carcinogens (KCC) reported in the literature, and via high-throughput screening data, the authors found a lack of evidence for activity across the mechanistic database. These results align with the overall lack of tumor response to Ace K in mammalian carcinogenicity studies, corroborating previous reports of a lack of carcinogenicity related to Ace K exposure. This open-access publication is the third in a series of assessments for non-nutritive sweeteners, following aspartame and sucralose, all published in Food and Chemical Toxicology.

21CT scientists publish on assessment of mechanistic data for synthetic food dyes and neurobehavioral signals

A recently published article by ToxStrategies scientists Dr. Grace Chappell, Dr. Susan Borghoff, and Dr. Janice Britt presents the evaluation of mechanistic data in an assessment of potential neurobehavioral effects for the seven synthetic colors that are approved for use in food by the US FDA. The assessment was specific to in vitro and other new approach methods (NAMs). A systematic identification of molecular events potentially related to neuro-relevant processes and outcomes was conducted to enable mapping of high-throughput screening (HTS) assays from the ToxCast/Tox21 database to such molecular events and/or related genes. Based on the mapping, neuro-relevant HTS data for seven FDA-approved synthetic food colors were evaluated, as well as neuro-relevant NAMs data for the colors identified in published literature. The findings support an overall lack of neuro-related activity associated with the seven food colors, with the exception of neurotransmitter signaling by erythrosine. The open-access article was published in Food and Chemical Toxicology.

Publication on lack of aspartame carcinogenicity

A recently published article by ToxStrategies scientists, with Dr. Daniele Wikoff as lead author, presents the systematic identification, appraisal, and integration of mechanistic data in an assessment of potential carcinogenicity of the non-nutritive sweetener aspartame. Based on the evaluation of over 1300 measurements/assay endpoints related to one or more key characteristics of carcinogens (KCC) reported in the literature and via high-throughput screening data, the authors found a lack of evidence for activity across the mechanistic database. These results align with the overall lack of tumor response to aspartame in rodent cancer bioassays, corroborating previous reports of a lack of carcinogenicity related to aspartame exposure. The open access article can be found here: https://www.sciencedirect.com/science/article/pii/S0278691519306568

21CT authors publish systematic framework for mechanistic data

A new article from authors in the Center of Excellence for 21st Century Toxicology describes a framework to systematically and quantitatively integrate mechanistic data in assessments of potential carcinogenicity. The framework builds on the key characteristics organizational approach that is being implemented by authoritative bodies globally, by accounting for the quality and relevance of individual studies when developing weight-of-evidence conclusions regarding the activity of key characteristics. The proposed framework provides a flexible solution to quantitively integrate all available data in a systematic and transparent manner that accords greater weight to data that are best suited to the assessment of potential human carcinogenicity. The paper by Dr. Daniele Wikoff and colleagues has been accepted for publication in Toxicological Sciences and is on the 21CT website.