Conventional Test Method:

Prenatal Developmental Toxicity Study (OECD TG 414)

Alternative Test Method:

Name & Description:

Embryonic Stem Cell Test (EST)

Embryotoxic potential of chemicals is determined by the evaluation of the inhibition of growth of the murine embryonic stem cell line D3 (ES D3) and 3T3 fibroblast cells and the inhibition of differentiation of ES D3 cells into spontaneously contracting cardiomyocytes. For use as adjunct/ screening test to OECD TG 414.

Validation Status:

EU: Endorsed as valid by ECVAM  for identifying non-, weakly and strongly embryotoxic chemicals
(2002)

Regulatory Status:

None

Effect or Potential Effect on Animal Use:

Reduction
(For use as in vitro component of in vitro/in vivo reproductive toxicity testing strategy)

References:

• ECVAM (2002) ESAC Statement on the use of scientifically-validated in vitro tests for embryotoxicity.
• ECVAM (2002) Embryonic Stem Cell Test (EST): INVITTOX no. 113. Embryotoxicity/Teratogenicity.
• Genshow,E., Spielmann, H., Scholz, G., Seiler, A., Brown, N., Piersma, A., Brady, A., Clemann, N., Huuskonen, H., Paillard, F., Bremer, S., and Becker, K. (2002) The ECVAM international validation study on in vitro embryotoxicity tests: results of the definitive phase and evaluation of prediction models. ATLA 30: 151-176
• ReProTect (2006) ReProTect General Information: Embryonic Stem Cell Test. 
• Spielmann H., Seiler A., Bremer S., Hareng L., Hartung T., Ahr H., Faustman E., Haas U., Moffat G.J., Nau H., Vanparys P., Piersma A., Sintes J.R. & Stuart J. (2006) The practical application of three validated in vitro embryotoxicity tests:  The report and recommendation of an ECVAM/ZEBET workshop (ECVAM workshop 57). ATLA 34: 527-538.

Information Last Reviewed:

May 2012