Exhibitor-hosted session on March 18, 10:45 a.m.- 11:45 a.m., SOT Annual Meeting 2025

This session explores advanced toxicological strategies for assessing particulate and fibrous materials (e.g., CNTs) with a focus on carcinogenicity, 3R and novel methods for generating complex aerosols. Experts will present challenging endpoint approaches aimed at capturing all critical toxicological data from a single animal model such as genotoxicity (e.g., Comet assay) or cardiotoxicity (e.g., ECG) and discuss innovative aerosol generation for precise exposure control in toxicology research.

Participants will learn how new endpoints can be implemented into inhalation studies to meet upcoming regulatory requirements and how innovative aerosol generation can be used to enhance data accuracy and efficiency, facilitating comprehensive toxicological assessments from minimal animal use. The session will provide insights into overcoming exposure and analytical challenges in inhalation toxicology, advancing both ethical and scientific standards in risk assessment.

Dr. Gustav Bruer is head of the Department of Inhalation Toxicology at Fraunhofer ITEM. He is an expert in the toxicological assessment of airborne particles and fibers, focusing on deposition, clearance, and retention in the lungs. His research primarily includes inhalation, instillation and oral studies with particles such as silica, metals, mineral and carbon fibers, including ultrafine and nano-sized fractions.

He is specialized in designing and conducting tailormade in-vivo studies based on regulatory requirements from authorities like ECHA and EFSA, supporting customers from pharmaceutical and chemical companies worldwide.

Dr. Katharina Schwarz is is head of the Department of “Inhalation and Aerosol Research” at Fraunhofer ITEM.

She is an expert at the interface between aerosol and inhalation research, respiratory pharmacokinetics, toxicology and physiology, and inhalation exposure science with a special focus on particle lung dosimetry and biophysical particle-lung interactions. She is responsible for the aerosol/inhalation and dosimetry-related/QIVIVE-related aspects in drug development programs and toxicological or inhalation exposure studies including GLP/GCP-compliance. Customers are major pharmaceutical, chemical and cosmetic companies from Europe and US as well regulatory authorities. 

A particular focus of her research is on inhalation exposure and safety assessment of (cosmetic) spray products including development of approaches for quantitative in-vitro to in-vivo extrapolations (QIVIVE) for respiratory toxicity and risk assessment.  She has also a proven track record of successfully leading various national and international research and development projects in the field of inhalation exposure characterization and assessment also for regulatory purposes, including pioneering works in the exposure assessment of biocidal and cosmetic spray products.

Dr. Florian Schulz is a biochemist and trained human toxicologist. He joined Fraunhofer ITEM in 2011. As a Study Director for GLP-compliant guideline studies (OECD, EUR 18748 EN) in the Department of Inhalation Toxicology, he investigates the toxicological effects of airborne substances in the respiratory tract. His research focuses particularly on fiber toxicity, including in-vivo biopersistence studies of mineral wool products, as well as studies on the inflammatory effects and carcinogenicity of carbon nanotubes (CNTs), carbon fibers, and other fibrous materials. These studies also involve extensive size characterization using scanning electron microscopy (SEM) analysis.