Certification of different mass fractions of DP202216 in maize seed powder : ERM®-BF444c, ERM®-BF444d and ERM®-BF444e

In the field of developmental neurotoxicity and endocrine disruption, there is a need for in vitro methods that are suitable for regulatory use and can measure specific changes in the human brain. In the search for a suitable, commercially available cell model, EURL ECVAM requested a contractor to evaluate the quantity and reproducibility of myelin formation in 3D mixed (neuronal/astrocyte and oligodendrocyte) cultures (brain spheres) derived from human induced pluripotent stem cells (hiPSCs). The results from neurospheres derived from the commercially available cell line were compared with results from an in-house model that was already established in the contractor's laboratory. The study shows that the investigated cell model produces myelin that can be reliably measured, but challenges remain for the reproducible measurement of increased or decreased myelination in the brainspheres upon chemical exposure. This study contributes to the validation of suitable in vitro models that, when accepted for regulatory use, can reduce the amount of animals used for scientific purposes according to Directive 2010/63/EU.