The European Chemicals Agency (ECHA) recently conducted a review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study, or EOGRTS). The project’s goal was to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently …
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 12 test cases of …
Five critical success factors for navigating EOGRTS complexity and smoothing the progress of your chemical registration
The EOGRTS or OECD 443 is a scientifically and logistically complex study. Five critical success factors can help you overcome the complexities to achieve DART success.