Uncovering the Regulatory Advice Affecting OECD 443 Study Design and the Impact on Your Ongoing and Future Studies

The Extended One Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, Annexes IX and X, Section 8.7.3.) since March 2015. In July 2021, an evaluation of Organisation for Economic Cooperation and Development (OECD) 443 studies led by the European Chemicals Agency (ECHA) revealed critical issues with study designs that had the potential to compromise data analysis and interpretation.

Resulting regulatory advice had an immediate impact upon the design of ongoing and planned OECD 443 studies. Recommendations emphasized demonstrating the highest possible dose level showing reproductive effects without severe suffering or deaths in P0 animals and provided clarity on expectations for histopathology of Cohort 1B animals and intermediate and low dose level groups.

Required investigations for F2 offspring and immunotoxicity assessment in adults and offspring were clarified along with expectations for adequate documentation of methodology. A significant recommendation was the need for 60 offspring/sex/group to be evaluated for attainment of sexual maturation. For many study design variants, this requires an additional cohort of animals on the study, having a significant impact upon resources and cost.

This webinar will discuss a retrospective analysis of studies conducted at Labcorp comparing anonymized sexual maturation data to assess the relative merits of increasing the number of animals evaluated. These recommendations have resulted in the necessity to amend the design of ongoing and planned studies ultimately affecting resources, time and cost of a study which was already complex and costly.

Join this webinar to learn about the relative merits and consequences of these recommendations from a practical perspective.

Speakers

Steven Renaut, Associate Director, Development and Reproductive Toxicology (DART), Labcorp

Steven Renaut joined the Division of Toxicology based in Eye, Suffolk in 1999 as a Study Director before progressing to become a Team Leader in 2009. In 2016, Steven moved to a commercial manager position providing revenue forecasting and reporting for the Toxicology Division. In 2019, Steven returned to Study Direction as a Team Leader, and in September 2020 was promoted to Associate Director for DART where he is responsible for the day-to-day operation and performance of the scientific staff within the DART Study Direction group, including workload assignments, performance evaluations, salary administration, staffing decisions, organizational structure, and other supervisory activities for the department, in addition to planning and managing of business development and marketing activities for department. Steven graduated with a BSc (Hons) in Human Life Science from Norwich City College and has published work in Reproductive Toxicology 74 (2017) 59–69.

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Julie Passage, Study Director, Safety Assessment, Crop Protection and Chemicals, Labcorp

Julie Passage joined the Dow Chemical Company based in Midland, Michigan in 2001 as a Technologist in the DART group before progressing to become a Study Director in 2014. In 2021, Julie joined the Crop Protection and Chemical Toxicology group as a Study Director, where she is responsible for the technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results in compliance with appropriate SOPs, GLPs, Home Office License requirements and regulatory agency guidelines. Julie graduated with an AS in Veterinary Technology from St. Petersburg College and a BS in Biology from Saginaw Valley State University and has published work in MI AALAS Research Technician News. Jul 2009, Toxicologic Pathology 2010;38(2):244-57, Regulatory Toxicology and Pharmacology 2012 Jul;63(2):209-24 and 2018 Apr;94:57-69, Toxicological Sciences 2013 Dec;136(2):294-307 and 527-47, and Reproductive Toxicology 2020 Apr;93:146-162.

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