Regulatory research and risk assessment of chemical substances

We are committed to assessing possible risks from chemical agents including their use in specific products. We use a tiered approach for this, referred to as integrated testing strategy (ITS).

We offer our clients the studies and services required to assess the potential risks of chemicals to human health and the environment and to register these substances for the intended use. This includes industrial chemicals, biocides, food additives, and human and veterinary medicinal products. In close cooperation with our clients, we compile the data required for registration according to current legislation.

With self-initiated research projects, we contribute to the development of novel assessment strategies to help improve and refine existing risk assessment methods and ultimately to minimize the need for experimental studies, in particular animal studies. Examples of such projects are elucidation of structure-activity relationships ((Q)SAR), category approaches such as read across, the setting up of databases, and further development of the TTC concept.

Regulatory research and risk assessment in drug development

Our services and expertise

Data gap analysis and literature search: In cooperation with you, we determine what data are available and whether additional studies are necessary, and we check whether there is information publicly available about the substance in question. We are particularly experienced in working with substance categories and read-across.

Dossier preparation: We prepare IUCLID-5 datasets for the studies, perform exposure and risk assessments, and prepare a chemical safety report (CSR) and the registration dossier.

Counseling and support: We provide comprehensive counseling services and together with you develop a registration strategy tailored to your situation.

Study design and monitoring: Experimental investigations, e.g. for toxicology testing, can be performed directly at Fraunhofer ITEM or are subcontracted to other testing institutes.

Risk assessment and expert reports: In the form of expert reports, we document the  (eco-)toxicological properties of substances and assess their risks to human health and the environment, also beyond the scope of REACH, for example, in the event of contamination or chemical residues in foods and products.

Your benefits

Clients benefit from our synergies between experimental toxicology, comprehensive analytical methods, and regulatory expertise.

We act as mediators between our clients and public authorities, actively participate in panels which prepare legislation, and collaborate with national and international scientific organizations.

We analyze the available data for data gaps and close existing gaps by using structure-activity relationships ((Q)SAR models), read across, or waiving; whenever necessary, we develop an optimized testing strategy.

Besides access to other public databases, we have proprietary toxicological databases (RepDose, FeDTex, PaFTox) which we can customize to your specific requirements.

Project insights

Scientific basis

Further development of the TTC concept, derivation of a TTC for inhalation exposure, derivation of extrapolation factors, concepts for categorization of (nano-)particles

Toxicology databases

Database development and queries, e.g. with regard to repeated-dose toxicity (RepDose) and reproductive and developmental toxicity (FeDTex)  

Read-across and QSAR

Models of qualitative or quantitative structure-activity relationships, investigation of structurally related substances, development and assessment of substance categories