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Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
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Classification of reproductive toxicants with diverse mechanisms in the embryonic stem cell test

Christian Riebeling1, Kristin Fischer, Andreas Luch

  • 1Department of Experimental Toxicology and ZEBET, German Federal Institute for Risk Assessment (BfR), Germany.

The Journal of Toxicological Sciences
|November 13, 2015
PubMed

Insights

The embryonic stem cell test (EST) effectively identifies embryotoxic substances in vitro. This study confirmed EST

Area of Science:

  • Toxicology
  • Developmental Biology
  • In Vitro Testing

Background:

  • The embryonic stem cell test (EST) is a valuable in vitro method for assessing embryotoxicity.
  • Limitations in the EST's applicability domain and prediction model require further definition.

Purpose of the Study:

  • To evaluate the effectiveness of the EST in detecting known reproductive toxicants.
  • To compare EST predictions with regulatory hazard classifications.

Main Methods:

  • Eight substances with known reproductive toxicity were tested using the EST under blind conditions.
  • A prediction model was applied to EST data, classifying substances based on published criteria.
  • EST results were simplified into two classes for hazard assessment and compared to EU CLP Regulation labels.

Main Results:

  • The EST accurately identified most substances labeled as reproductive toxicants by the EU CLP Regulation as embryotoxic.
  • Substances without reproductive toxicity labels were generally found to be non-embryotoxic by the EST.
  • One substance showed a discrepancy between its CLP label and EST result.

Conclusions:

  • The EST demonstrates high concordance with regulatory classifications for reproductive toxicity.
  • The EST serves as a reliable in vitro tool for hazard assessment of developmental toxicity.
  • Further refinement of the EST's prediction model and applicability domain is supported by these findings.

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