Yvonne Kohl

Incorporation of Information from New Approach Methods into SSbD Workflows

Safety plays a crucial role in all areas of product development leading up to market launch. In order to obtain reliable and rapid information on safety in all stages of development (from early design phase to product application), there is a great need for faster and more human relevant safety testing along the life cycle. New Approach Methodologies (NAMs) have the potential to fundamentally transform today’s regulatory work by allowing more human-relevant decision-making in terms of both hazard and exposure assessment. Coupling mechanistic data with an understanding of adverse outcome pathways (AOPs) of toxicity lays the groundwork for NAMs.

To support the design of new SSbD-based chemicals and materials, the SSbD4CheM project develops and improves innovative models for human health and environmental safety assessment to a more robust, reliable and efficient running screening method, in line with the 3Rs principles – Replace, Reduce, Refine. These include in vitro, ex vivo and zebrafish embryo models. In SSbD4CheM we focused on the development of such innovative in vitro and in silico approaches and their potential application in next-generation risk assessment.

The alternative 3Rs models will be applied for adequate exposure scenarios in different specific case studies (cosmetics, automotive, textile). The SSbD4CheM project will develop a data library of hazardous properties and effect data (e.g. NOAEL, NOECh) using NAMs to fill knowledge gaps on short-term and long-term effects (low doses, chronic exposure). The presentation will highlight the alternative 3Rs model applications in the project's case studies and the advantages of incorporating information from NAMs into SSbD workflows.

Biography

Yvonne Kohl is a senior scientist at the Fraunhofer Institute for Biomedical Engineering IBMT and Scientific Specialist for Toxicology. Her main research focus is on the development of NAMs based on human-relevant and alternative in vitro methods according to the 3Rs principle to assess human impacts of nanoscale materials and chemicals. One specific focus is on in vitro barrier transport studies and its use for SSbD studies for next-generation hazard assessment.