ICH S5 (3R) is advancing the way for the acceptance of alternative models for developmental and reproductive toxicity (DART) testing by optimizing the validation requirements and promoting regulatory confidence in new approach methodologies. In vitro models validated based on these guidelines serve as powerful tools within weight-of-evidence approaches in different frameworks for DART testing.

At Toxys we have developed the ReproTracker assay: a human stem cell-based in vitro assay that differentiates induced pluripotent stem cells towards three germ layer-specific cell types: cardiomyocytes (mesoderm), hepatocytes (endoderm), and neural rosettes (ectoderm). This system enables the assessment of teratogenic potential by tracking alterations in biomarker expression and observing morphological disruptions in the differentiated cells upon compound exposure.

In this webinar, we will present the results of our validation study using the compound list indicated in the ICH S5 (3R) guidelines (32 compounds). Following the identification of human developmental toxicants in ReproTracker, we will elaborate on the clinical relevance of the concentrations detected in the context of their respective human therapeutic Cmax values.

In this webinar, you will learn about:

• Teratogenicity classification of ICH S5 (3R) reference compounds by ReproTracker
• Correlations of predicted LOAELs with their corresponding human therapeutic Cmax
• The predictive potential of ReproTracker to detect teratogenicity of chemicals.

Presentations by:

Webinar on ReproTracker ICH S5(R3) validation

When: 2 October 2025, 4:00-5:00 pm CET