Regulatory safety and toxicology

A special focus of toxicological testing at Fraunhofer ITEM is on inhalation toxicology studies.
© Fraunhofer ITEM

A special focus of toxicological testing at Fraunhofer ITEM is on inhalation toxicology studies.

For risk assessment and registration, we offer toxicological, toxicokinetic, pharmacokinetic, and safety pharmacological studies in rodents and – in cooperation with other institutions – also in non-rodents. These studies are performed in compliance with the international ICH registration guidelines, under which we have been GLP-certified since 1991. A special focus is on inhalation toxicology studies, an area of expertise where we have several decades of experience and international reputation.

Overview of our services and expertise

Regulatory assessment by means of standard tests in compliance with international guidelines (OECD, EU, EPA or FDA)

In-vivo studies (relevant species, single-dose and repeated-dose toxicity, safety pharmacology)

In-vitro studies (genotoxicity, molecular toxicity, screening tests)

Standard routes of administration, intratracheal, nose-only and whole-body inhalation exposure

Toxicokinetics, bioanalytics and formulation analytics

Histopathology

Immunohistochemical techniques

Cell proliferation assays (e.g. BrdU, PCNA)

Clinical chemistry and hematology

Genotoxicity

Ames test

Micronucleus assay

Comet assay

Chromosomal aberration test

Immunotoxicity

Endpoints in standard toxicity studies according to ICH S8

Weight-of-evidence review

Product-tailored additional studies on immune function and immunotoxicity

Safety pharmacology

Cardiovascular system: telemetered animals (in cooperation)

Central nervous system: functional observational battery, locomotor activity

Respiratory system: body plethysmography

For risk assessment and registration, Fraunhofer ITEM offers toxicological, toxicokinetic, pharmacokinetic, and safety pharmacological studies.
© Fraunhofer ITEM

For risk assessment and registration, Fraunhofer ITEM offers toxicological, toxicokinetic, pharmacokinetic, and safety pharmacological studies.

Special inhalation toxicology portfolio

Fraunhofer ITEM has several decades of experience and international reputation in the field of inhalation toxicology.
© Fraunhofer ITEM

Fraunhofer ITEM has several decades of experience and international reputation in the field of inhalation toxicology.

Inhaled administration and toxicity assessment of:

Pharmaceuticals including small molecules, recombinant proteins, and non-standard products such as cell and gene therapies or bacteriophages

Nanoparticles and novel formulations

Poorly soluble particles

Complex project designs for adequate toxicological characterization

Guideline-compliant study performance

State-of-the-art inhalation and measurement equipment

Studies up to large scale with eight exposure groups in parallel

Nose-only and whole-body exposure

Generation of complex inhalation atmospheres (solids, liquids, volatiles, semi-volatiles, suspensions)

Suitability tests of aerosol generators for toxicity testing

Physical, chemical, and biological characterization of test atmospheres