Scientific and Regulatory Policy Committee Points to Consider: Fixation, Trimming, and Sectioning of Nonrodent Eyes and Ocular Tissues for Examination in Ocular and General Toxicity Studies. (February 2022)

• Record Type: Journal Article
• Authors: Booler, Helen S.; Lejeune, Typhaine; Sorden, Steven; Gruebbel, Margarita M.; Schafer, Kenneth A.; Short, Brian; Farman, Cindy; Ramos, Meg Ferrell; Bennet, Bindu; Yekkala, Krishna; Atzpodien, Elke-Astrid; Turner, Oliver C.; Brassard, Jaqueline; Foley, George
• Is Part Of: Toxicologic pathology. Volume 50:Number 2(2022)
• Page Start: 235
• Page End: 251
• Publication Date: 2022-02
• Subjects: eye -- retina -- toxicity studies -- area centralis -- visual streak -- fovea -- macula; Pathology -- Periodicals; Toxicology -- Periodicals; Pathology; Toxicology; 615.9
• DOI: 10.1177/01926233211047562
• Languages: English
• ISSNs: 0192-6233

Abstract

A Working Group of the Society of Toxicologic Pathology's Scientific and Regulatory Policy Committee conducted a technical and scientific review of current practices relating to the fixation, trimming, and sectioning of the nonrodent eye to identify key points and species-specific anatomical landmarks to consider when preparing and evaluating eyes of rabbits, dogs, minipigs, and nonhuman primates from ocular and general toxicity studies. The topics addressed in this Points to Consider article include determination of situations when more comprehensive evaluation of the globe and/or associated extraocular tissues should be implemented (expanded ocular sampling), and what constitutes expanded ocular sampling. In addition, this manuscript highlights the practical aspects of fixing, trimming, and sectioning the eye to ensure adequate histopathological evaluation of all major ocular structures, including the cone-dense areas (visual streak/macula/fovea) of the retina for rabbits, dogs, minipigs, and nonhuman primates, which is a current regulatory expectation for ocular toxicity studies. This Points to Consider article is a product of a Society of Toxicologic Pathology (STP) Working Group commissioned by the Scientific and Regulatory Policy Committee (SRPC) of the STP. It has been reviewed and approved by the SRPC, Executive Committee of the STP, the European Society of Toxicologic Pathology, and the British Society of Toxicological Pathology, but it does not represent a formal Best Practice recommendation of the Society; rather, it is intended to provide key "points to consider" for the toxicologic pathology community. The points expressed in this document are those of the authors and do not reflect views or policies of the employing institutions. Readers of Toxicologic Pathology are encouraged to send their thoughts on this article or ideas for new topics to the editor.