Kristie Sullivan and Mark Cronin, Chairpersons, 2017 CE PM13
While the use of read-across and other techniques based on chemical structure to understand toxicological hazard have been used for several decades, expanded interest in using such techniques to minimize in vivo testing coupled with advances in what can be collectively referred to as New Approach Methodologies (NAMs) has led to a flurry of recent discussion and definition of best read-across practices.
This course, Read-Across: Case Studies, New Techniques, and Guidelines for Practical Application, is offered to provide participants clear, practical guidance in conducting read-across for chemical hazard assessment, from determining appropriate reference chemicals to reporting guidelines. Presentations will highlight key areas of controversy and recognize best practice, available tools to support specific aspects of read-across, and demonstrative case studies to facilitate learning objectives and increase consistency of read-across practice in the toxicological community. Identifying and addressing areas of uncertainty and building scientific confidence in read-across methodologies will be a particular focus.
Hybrid read-across refers to the use of biological, as well as chemical, information to conduct read-across. Biological information from NAMs such as in vitro or high-throughput methods, as well as other structure and non-structure-based chemical characteristics, can improve the utility and regulatory acceptance of read-across. This course will discuss important data quality considerations, offer perspectives on the impact of different kinds of similarity metrics, and provide case studies that take advantage of NAM data.
Addressing regulatory acceptance is a major feature of the course and an area of active work in the regulatory toxicology community. Accordingly, this course will feature presentations addressing European Chemicals Agency guidance in the form of the Read-Across Assessment Framework (RAAF), including information about the RAAF as well as case studies illustrating its application. The final presentation will pull together the entire course, using one case study to guide course participants through an entire read-across “from the ground up.” For information on the entire CE program, please visit the SOT website.