Toxicologic Pathology Forum*: Opinion on Designation of Adverse and Nonadverse Histopathological Findings in Toxicity Studies: The Pathologist’s Dilemma

Abstract

In this opinion piece, we discuss some proposed principles for designating adversity and nonadversity of histopathological changes. The suggested approach categorizes the classes of findings noted in toxicity studies with illustrations and examples and suggests adversity or nonadversity for each class, in the authors’ opinions, with rationales. Although the suggestions and examples offered in this opinion piece are generally in agreement with Society of Toxicologic Pathology best practices guideline on adversity, the authors suggest and highlight occasional divergences and differences of opinion. This is because making an adversity call is a complex and challenging topic that is difficult to simplify. Some of the challenges in deciding on adversity are discussed, especially those related to making an adversity call on a histopathological finding in isolation, based on the nature and extent of severity. The authors demonstrate some of these situations with examples. Finally, the authors suggest, in contrast to the guidelines, occasional use of a separate category for findings that are less easily classified. *This is an opinion article submitted to the Toxicologic Pathology Forum. It represents the views of the author(s). It does not constitute an official position of the Society of Toxicologic Pathology, British Society of Toxicological Pathology, or European Society of Toxicologic Pathology, and the views expressed might not reflect the best practices recommended by these Societies. This article should not be construed to represent the policies, positions, or opinions of their respective organizations, employers, or regulatory agencies.