Validation of the Embryonic Stem Cell Test in the International ECVAM Validation Study on Three In Vitro Embryotoxicity Tests

Abstract

A detailed report is presented on the performance of the embryonic stem cell test (EST) in a European Centre for the Validation of Alternative Methods (ECVAM)-sponsored formal validation study on three in vitro tests for embryotoxicity. Twenty coded test chemicals, classified as non-embryotoxic, weakly embryotoxic or strongly embryotoxic on the basis of their in vivo effects in animals and/or humans, were tested in four laboratories. The outcome showed that the EST can be considered to be a scientifically validated test, which is ready for consideration for use in assessing the embryotoxic potentials of chemicals for regulatory purposes.

Thalidomide induced early gene expression perturbations indicative of human embryopathy in mouse embryonic stem cells

“…Embryonic stem cells (ESCs) have gained considerable interest for their use in developmental toxicity testing by virtue of their fundamental attribute of unlimited expansion and unique potential to differentiate into all somatic cell types (Tandon and Jyoti, 2012). The EST was initially developed as an in vitro model for the screening of embryotoxicity based on the interference of chemicals with the differentiation of mouse embryonic stem cells (mESCs) into beating cardiomyocyte foci in culture (Heuer et al, 1993;Spielmann et al, 1997), and was successfully validated by the European Center for the Validation of Alternative Methods (ECVAM) (Genschow et al, 2004).…”

The effects of Boehmeria nivea (L.) Gaud. on embryonic development: In vivo and in vitro studies

“…doi:10.1016/j.jep.2010.12.034 mechanisms of developmental toxicity. The European Centre for the Validation of Alternative Methods (ECVAM) designed the protocol of ESC tests as a tool for classifying compounds according to their potential of developmental toxicity (Genschow et al, 2004;Paquette et al, 2008). The test is the most promising in vitro assay to anticipate the embryotoxic potential of substances at present and "the first in vitro embryotoxicity test in which no pregnant animals have to be sacrificed to obtain embryonic tissue for the in vitro culture" (ECVAM, 2002).…”

Reprotoxicity of intrauterine insemination and in vitro fertilization-embryo transfer disposables and products: a 4-year survey

“…Exposed mouse embryos are being cultured in vitro or transplanted in vivo to test their developmental potential (14,18). Culture of mouse embryonic stem cells can also be used to identify reprotoxic media or materials that could influence the differentiation process after implantation (12,23).…”