Design of the EOGRTS
The study design of the EOGRTS is basically a combination of the OECD TG 416 (two generation reproduction toxicity study) and the OECD TG 426 (Neurodevelopmental toxicity study) and a T-cell dependent antibody response test. The combined test had originally been applied more frequently in agricultural product development before it was adopted by ECHA.
Combining a two generation reproduction toxicity study with a neurodevelopmental toxicity study can reduce the number of laboratory animals and the costs. The reduction of experimental animal use is one of the objectives of REACH. However, the neurodevelopmental toxicity study is not always required for industrial chemicals and consequently the cost efficiency argument may lose some of its weight. A major advantage of the EOGRTS is that it provides significantly more information than the two generation reproduction toxicity study, due to the substantially larger number of endpoints included. For this reason, ECHA currently requires the EOGRTS and no longer the two generation reproduction toxicity study.
An EOGRTS is an expensive and time-consuming part but very important part of the registration dossier. For this reason, the study needs professional project management. Each Triskelion EOGRTS project is led by our most experienced project managers and study directors throughout its 16 – 18 months turnaround time. The overall testing program will involve not only an EOGRTS but more often than not also several other in vitro and in vivo toxicity studies, pilot studies and Dose Range Finding studies. It is not uncommon for the duration of such a project to exceed 2.5 years. During that time, you can rest assured that Triskelion will take care of your toxicology needs.