IIVS, Advancing Science & Animal Welfare Together | SOT 2024 Issue

AM05: New Approach Methodologies for Primary Dermal Irritation: Implementing Human-relevant Testing Approaches

Hans Raabe, IIVS COO, will take part in a CE course, introducing in vitro and in chemico test methods which have been validated for identifying GHS Category 1 and 2 ocular irritants, and are applicable to classifying substances into EPA categories I and II. The presentation will consist of highlighting multiple assays which have been developed and validated for international regulatory purposes. The course also includes a discussion of current applicability and limitations of these methods and how they can be used to support categorization and labeling requirements and coverage of other test methods under development which may be able to discriminate between mild and moderate irritation categories.

PM13: Human-Derived In Vitro and Ex Vivo Test Systems to Assess Respiratory Toxicity of Chemicals

Holger Behrsing, Director of Respiratory Services, will present an an overview of in vitro and ex vivo pulmonary models and discuss the advantages and challenges in their incorporation into screening and testing strategies. Holger will cover both 2-D models as screening tools as well as 3-D organotypic models of the airway tract including Reconstructed human airway tissues, humna-donor derived spheroids and organoids. There will also be time devoted to a presentation on the utility of Precision-Cut human Lung Slices (PCLS) to model traditional endpoints such as cytotoxicity as well as chronic-exposure related adverse outcomes (e.g. persistent inflammation, goblet cell hyperplasia) and functional outcomes (modulation of ciliary beat frequency) which may reflect serious health complications that can lead to various disease states.

PM12: Bridging the Gap: Educational Needs and Resources

Kristie Sullivan, VP of Education and Outreach will Co-chair and introduce “Allergies Are More Than Skin Deep: Establishing Regulatory Test Methods for Respiratory Sensitization”. This session will update attendees on the latest progress in exploring assessment approaches to identify respiratory sensitizing materials, and evaluate and implement promising approaches to meet international regulatory needs.

Hans will co-present with Toxys CEO Giel Hendricks on "In Vitro Assays for Genetic Toxicity, Developmental Toxicity, and Mechanistic Toxicity". He will specifically discuss the transferability of the ToxTracker assay and availability in the US. Also included in this session will be case studies from scientists who have implemented ToxTracker and other assays developed by Toxys at their own facilities.

Kristie Sullivan, VP of Education and Outreach will present during “The Modernization of the Cosmetic Regulation Act: Perspectives on Recent Implementation Activities and Confirming Safety in Cosmetic Products”. This sessions features presentations and a panel discussion from FDA, industry, consultant, and non-profit experts to share the latest updates on MoCRA implementation. Kristie's presentation, The Future of NAMs in Informing Safety for Cosmetic Ingredients and Products, will discuss how nonanimal methods can fulfill safety assessment needs for companies and FDA under MoCRA.