Testing strategies and structure-activity relationships

Alternative methods to animal testing are required to reduce animal tests, e.g. under REACH. Our working group QSAR/New Methodologies for Risk Assessment is involved in several projects developing strategies for human risk assessment within the European Framework Programs 6 and 7 and in projects sponsored by the chemical industry. In this context, two databases – RepDose and FeDTex – have been developed to address repeated-dose and reproductive toxicity.

RepDose – Repeated-Dose Toxicity:
RepDose, a database funded by Cefic LRI, contains peer-reviewed and confidential repeated-dose toxicity studies in rodents with subacute to chronic exposure durations. It is a continuously growing database and currently contains about 650 chemicals and 2500 studies. The database is available at: www.fraunhofer-repdose.de.

FeDTex – Reproductive and Developmental Toxicity:
FeDTex is a database on reproductive toxicity with a focus on one- and two-generation studies. Parameters and effects describing maternal toxicity, reproductive performance, and developmental toxicity are documented according to affected generation, developmental stage, and sex. The database can be used both for risk assessment and for structure-activity analyses.

Our services and expertise

Development and assessment of chemical categories

Assessment of chemicals using read across and/or structure-activity relationships

Development of risk assessment methodologies, e.g. TTC and extrapolation factors

Analysis of modes of action

Development of databases for toxicological endpoints

All services can be performed with customized datasets (existing databases, literature search, confidential data).

 

 

Selected projects

ExITox – Explain Inhalation Toxicity. Development of an integrated testing strategy for the prediction of toxicity after repeated dose inhalation exposure: a proof of concept (more information on this project)

EU-ToxRisk: toxicological risk assessment. An integrated European "flagship" program driving mechanism-based, animal-free toxicity testing and risk assessment for the 21st century (more information on this project)

Category approach funded by the German Federal Ministry for the Environment, Nature Conservation and Nuclear Safety: development of a strategy to derive new categories for risk assessment based on the toxicological profile and/or the structural features of the substances

ChemScreen – Chemical substance and in-vitro/in-silico screening system to predict human- and ecotoxicological effects (EU FP7).

Analysis of extrapolation factors for route-to-route, interspecies, and time extrapolation for the industry consortium ERASM with special focus on surfactants

Evaluation of the threshold of toxicological concern (TTC) concept using RepDose; refinement of oral thresholds and the Cramer decision tree and derivation of TTC for inhalation exposure.

Cooperation with US EPA (ToxRef database, www.epa.gov/NCCT/toxrefdb) and TNO, The Netherlands Organization for Applied Scientific Research (Toxbase database)