EURL ECVAM strategy for achieving 3Rs impact in the assessment of toxicokinetics and systemic toxicity

Knowledge Source Identification
Knowledge source name EURL ECVAM strategy for achieving 3Rs impact in the assessment of toxicokinetics and systemic toxicity
Owner/Developer European Commission, Joint Research Centre
Abbreviated owner EC - JRC
Country Italy
Languages English
Description Information on human toxicokinetics plays an important role in the safety assessment of chemicals, even though there are few data requirements in the EU regulatory framework. While existing EU test methods and OECD test guidelines are mostly based on animal procedures, there are increasing opportunities to achieve a 3Rs impact in this area by exploiting modern developments. For example, whole-body toxicokinetic information can be obtained by using physiologically-based toxicokinetic (PBTK) models that integrate data generated by in vitro methods for absorption, distribution, metabolism and excretion (ADME). The development of an infrastructure providing access to such models and their underlying data needs to be accompanied by the establishment of standards for human in vitro ADME methods, the development of guidance on the development and application of such models and the creation of regulatory incentives. Taking these needs into account, this report describes the EURL ECVAM strategy to achieve a 3Rs impact in the area of toxicokinetics and systemic toxicity. The proposed activities are expected to lay the foundation for a risk assessment approach that is increasingly based on human data. Implementation of the strategy will rely on the coordinated efforts of multiple stakeholders.
Knowledge Source Category
Category Publication
Sub categories Report
Knowledge Dissemination and Sharing
Dissemination channel Website
Targeted audience (specified/objective analysis) Not specified
Users access Open access
Knowledge Characterization
3Rs relevance Replacement, Reduction, Refinement
Purpose Regulatory testing, Toxicological and safety evaluation, Method development, Documentation and information
Technology/Tools Alternative test methods (in vitro), Non-testing methods (in silico), Integrated approaches to testing and assessment (IATA)