Pathologists' perspective on the study design, analysis, and interpretation of proliferative lesions in lifetime and prenatal rodent carcinogenicity bioassays of aspartame. 2023

Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
ElmorePathology, LLC, Chapel Hill, NC, USA. Electronic address: elmorepathology@gmail.com.

Aspartame, an artificial sweetener commonly used as a sugar substitute, is currently authorized for use in more than 100 countries. Hundreds of studies, conducted in various countries dating back to the 1970s, have shown that aspartame is safe at real-world exposure levels. Furthermore, multiple human epidemiology studies have provided no indication that consumption of aspartame induces cancer. Given the continued controversy surrounding the Ramazzini Institute's (RI) studies suggesting that aspartame is a carcinogenic hazard in rodents and evaluation by the International Agency for Research on Cancer, this report aims to provide the perspective of experienced pathologists on publicly available pathology data regarding purported proliferative lesions in liver, lung, lymphoid organs, and mammary gland as well as their implications for human risk assessment as reported for three lifetime rodent carcinogenicity bioassays of aspartame conducted at the RI. In the authors' view, flaws in the design, methodology and reporting of the RI aspartame studies limit the utility of the data sets as evidence that this agent represents a carcinogenic hazard. Therefore, all three RI studies, and particularly the accuracy of their pathology diagnoses and interpretations, should be rigorously reviewed by qualified and experienced veterinary toxicologic pathologists in assessing aspartame's carcinogenic risk.

UI MeSH Term Description Entries
D009369 Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D002273 Carcinogens Substances that increase the risk of NEOPLASMS in humans or animals. Both genotoxic chemicals, which affect DNA directly, and nongenotoxic chemicals, which induce neoplasms by other mechanism, are included. Carcinogen,Oncogen,Oncogens,Tumor Initiator,Tumor Initiators,Tumor Promoter,Tumor Promoters,Initiator, Tumor,Initiators, Tumor,Promoter, Tumor,Promoters, Tumor
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000072142 Pathologists Physicians who assess changes in cellular or tissue structure and function to diagnose disease processes. Pathologist
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D001218 Aspartame Flavoring agent sweeter than sugar, metabolized as PHENYLALANINE and ASPARTIC ACID. Aspartylphenylalanine Methyl Ester,Canderel,Goldswite,Hermesetas Gold,Methyl Aspartylphenylalanine,Milisucre,Nozucar,NutraSweet,SC-18862,Tri-Sweet,Aspartylphenylalanine, Methyl,Gold, Hermesetas,Methyl Ester, Aspartylphenylalanine,SC 18862,SC18862,Tri Sweet,TriSweet
D001681 Biological Assay A method of measuring the effects of a biologically active substance using an intermediate in vivo or in vitro tissue or cell model under controlled conditions. It includes virulence studies in animal fetuses in utero, mouse convulsion bioassay of insulin, quantitation of tumor-initiator systems in mouse skin, calculation of potentiating effects of a hormonal factor in an isolated strip of contracting stomach muscle, etc. Bioassay,Assay, Biological,Assays, Biological,Biologic Assay,Biologic Assays,Assay, Biologic,Assays, Biologic,Bioassays,Biological Assays
D012377 Rodentia A mammalian order which consists of 29 families and many genera. Beavers,Capybaras,Castor Beaver,Dipodidae,Hydrochaeris,Jerboas,Rodents,Beaver,Capybara,Hydrochaeri,Jerboa,Rodent,Rodentias

Related Publications

Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
December 1987, Regulatory toxicology and pharmacology : RTP,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
January 2022, Shokuhin eiseigaku zasshi. Journal of the Food Hygienic Society of Japan,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
January 1983, Toxicologic pathology,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
March 1992, Risk analysis : an official publication of the Society for Risk Analysis,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
April 2019, Regulatory toxicology and pharmacology : RTP,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
July 2015, Regulatory toxicology and pharmacology : RTP,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
December 1992, Experimental and toxicologic pathology : official journal of the Gesellschaft fur Toxikologische Pathologie,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
April 1984, Transplantation proceedings,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
April 2011, Critical reviews in toxicology,
Susan A Elmore, and Jerold E Rehg, and Trenton R Schoeb, and Jeffrey I Everitt, and Brad Bolon
January 1986, IARC scientific publications,
Copied contents to your clipboard!