Role of Anatomic Pathology in Skeletal Evaluations: Applying INHAND Diagnostic Criteria

In animal studies, light microscopic examination remains an important tool in the detection and characterization of effects on the skeleton. In the case of both anticipated and unanticipated effects on bone histology, pathologists must carefully select terminology that accurately conveys skeletal morphology without overstating what information can be derived from a standard decalcified paraffin-embedded section. The International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) project issued standardized nomenclature for toxicologic pathologists to use with respect to the skeleton. Consistent with general INHAND principles, the nomenclature emphasizes a descriptive approach to classifying lesions, rather than using terms that imply a specific pathogenesis or disease process. This article, which is based on a presentation at the Society of Toxicologic Pathology's 36th Annual Symposium, will discuss the role of anatomic pathology evaluation in the context of skeletal evaluation in toxicity studies. The integration of anatomic pathology data with quantitative bone end points is reviewed. An overview of the INHAND diagnostic scheme is provided and accompanied by case examples in which the INHAND terminology has been applied. In addition, this review summarizes key considerations for toxicologists and pathologists assigning adversity designations when considering bone end points.