ECHA has published the final report from a group of satellite projects resulting from the review of extended one-generation reproductive toxicity studies (EOGRTS). Specific projects include:
- Thyroid system hormone measurements
- Nipple/areola retention
- Anogenital distance (AGD)
- Follicle and corpora lutea (CL) count
- The T-cell dependent antibody response (TDAR) assay
This report provides an overview of these projects and their recommendations to improve the design, conduct, analysis, and reporting of these studies. It supplements the report of the EOGRTS review project from March 2023. (link here)
The report highlights important considerations to inform design of future EOGRTS studies which should be considered to ensure regulatory success. The Blue Frog Scientific team holds considerable expertise in developmental and reproductive toxicity, and have overseen many EOGRTS.
Blue Frog Scientific's expert toxicologists can assist in guiding clients successfully through this complex study.