Next generation risk assessment to set the stage for the future

© Fraunhofer ITEM, Ralf Mohr

Fraunhofer ITEM stands for toxicology testing and risk assessment of chemicals, active substances and drugs – with a focus on inhalation toxicology. Continued development of the corresponding exposure methods enables very small amounts of test substances to be used with high efficiency in toxicological studies.

Next Generation Risk Assessment

While conventional toxicology testing is still the required regulatory standard, our researchers are contributing to new assessment strategies through their own research projects based on the next generation risk assessment concept, aiming to provide predictive models for assessing the safety of compounds.

Based on the precision-cut lung slices (PCLS) technology that is well established at the institute, more human or humanized ex-vivo organ models, for example of the heart and liver, are in the process of further development. These models can also be used to test biopharmaceuticals and advanced therapy medicinal products (ATMPs). To analyze the results, the researchers combine the traditional endpoints among others with omics technologies, in particular metabolomics and functional genomics, and complex advanced bioinformatics analyses.

Assessment methods based on databases, such as the TTC (threshold of toxicological concern) concept, are being further developed, for example to identify non-genotoxic tumorigenic substances or to allow these methods to be used for the development of medical devices as well.

Toxicology: recent projects and highlights


RISK-HUNT3R project

For next generation risk assessment of toxic effects, human-based testing strategies are being developed to reduce, refine and, wherever possible, replace animal testing. 


New-approach methodologies (NAMs)

The EFSA project "Development of roadmaps for action on NAMs in risk assessment" is aimed at prioritizing the incorporation of NAMs into chemical risk assessment.

Project ZeroPM: Zero pollution from persistent, mobile substances

Aimed at reducing the risk of our drinking water resources getting contaminated with persistent, mobile substances (PM).

Preclinical studies for repurposing of Aloxistatin

Fraunhofer ITEM performed inhalation toxicology studies under GLP conditions to prepare for regulatory approval of Aloxistatin. 

Focus on the food chain

In the EFSA project "Emerging Risk III" we investigate and assess potential risks from industrial chemicals that could possibly be present in the food chain.

MONO4ERA project

Feasibility study of an active-substance-based system and other potential alternatives for environmental risk assessment of veterinary medicinal products.


Understanding Cabin Air Quality

The recently launched research project ”Cabin air quality III“ is aimed at assessing long-term effects of contaminants that aircraft passengers and crew members are exposed to on board.


Toxicokinetics of carbon black

The toxicokinetic behavior of nanoscale particles after pulmonary deposition is of great scientific interest because they might have a potential for systemic exposure.

PREMIER project

Setup of a database that is to deliver relevant data for the development of models for prediction of environmental data to enable better assessment and characterization of the environmental risks of pharmaceuticals. 

Drug repurposing to fight COVID-19

In the RENACO project, scientists are testing the efficacy and toxicity of nafamostat, a drug approved for treating pancreatitis, as a therapeutic for COVID-19.


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