Since its adoption in 2011, the extended one-generation reproductive toxicity study (EOGRTS; OECD 443 test guideline) has become a key milestone in the assessment of potential effects of chemicals on fertility and development, including effects upon the developing nervous and immune systems. ECHA will normally require an OECD 443 for any chemical in the >100 tonne band, or at a lower tonnage if it has endocrine disruption potential.
This complex study also offers an opportunity to improve animal welfare, through reduction and refinement, in a modular (cohort) study design. The challenge for a CRO is to manage all cohorts, especially when those are triggered based on findings noted during the EOGRTS itself.
Thanks to comprehensive expertise in Developmental and Reproductive Toxicology, Citoxlab has the experience and know-how required to manage such a complex study.
In this Webinar, using experience gained during the execution and reporting of EOGRTS, Citoxlab will present the lessons learned in conducting full tests, discuss the development and benefits of performing such a study, and focus on the challenges faced both by registrants and CROs in meeting the volume of demand for EOGRTS in the coming years.