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EURL ECVAM publishes its strategy in the area of toxicokinetics

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Jul 14, 2015
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Reducing animal testing while improving the safety assessment of chemicals

The European Union Reference Laboratory for Alternatives to Animal Testing has published its Strategy for Achieving a 3Rs Impact in the Assessment of Toxicokinetics and Systemic Toxicity.

 

Information on the human toxicokinetics of chemicals is crucial in their safety assessment. Toxicokinetics determines what part of the external exposure to a chemical reaches the systemic circulation and potential target organs. It is driven by four processes: absorption, distribution, metabolism and excretion (ADME). Despite the usefulness of toxicokinetic information, there are few data requirements in the EU regulatory frameworks on chemicals. The EU test methods and OECD test guidelines that can be used to meet these data requirements are mostly based on animal procedures. However, by exploiting recent scientific and technological developments, there are increasing opportunities to achieve a 3Rs impact in this area. For example, whole-body toxicokinetics can be simulated by in silico physiologically-based toxicokinetic (PBTK) models that integrate data generated by human in vitro ADME methods.

 

The EURL ECVAM strategy concludes that progress in this field will depend on the availability of an infrastructure that provides access to PBTK models and their underlying data, 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. The EURL ECVAM report outlines a set of strategic aims and related objectives targeting these needs. 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. The strategy has undergone extensive consultation by EURL ECVAM's advisory and consultation bodies*. Its implementation will rely on a broad collaboration and the coordinated contribution from various stakeholders.

 

* EURL ECVAM Scientific Advisory Committee (ESAC), Preliminary Assessment of Regulatory Relevance (PARERE) Network, EURL ECVAM Stakeholder Forum (ESTAF), partner organizations of the International Cooperation on Alternative Test Methods (ICATM) and relevant European Commission DGs.

 

Full reference details in the JRC Science Hub.