The Future of Systemic Toxicity Testing: Animal-free

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In the Spotlight

The Future of Systemic Toxicity Testing: Animal-free

Catherine Willett, Humane Society of the United States

Published: May 9, 2012

A meeting to discuss a “scientific roadmap for the future of animal-free systemic toxicity testing” was held March 20-21, in Brussels. The 138 attendees included a broad range of international representatives from regulatory agencies, industry, and animal welfare organizations. Organized by the Center for Alternatives to Animal Testing – Europe (CAAT-Europe) and sponsored by a wide variety of organizations, the meeting presented the main findings from a previous, smaller workshop that proposed ways forward for non-animal approaches to repeat-dose toxicity testing (Basketter et al., 2012). Ample time was provided for discussion of these proposals.

Following overviews of current EU chemicals management policy and regulations as well as the CAAT and Safety Evaluation Ultimately Replacing Animal Testing (SEURAT) programs, summary findings from each of the workshop topic areas were discussed: repeat-dose testing, reproductive toxicity, skin sensitization, toxicokinetics, and carcinogenicity. The proposals centered on integrated testing strategies and assays based on pathways of toxicity. A broad consensus on this way forward emerged at the meeting.

In addition to specific recommendations for further development in each of these areas, main recurring themes from the discussion included:

  • the need for proof-of-principle case studies that demonstrate the application of new approaches
  • the need for assessment strategies designed based on the regulatory question they are meant to address
  • kinetics are fundamental to all toxicological assessment
  • validation of new approaches should be fit for purpose
  • as more biological information becomes available, it will be possible to validate by hypotheses rather than by comparison to data from other species.

Identified gaps include the need for:

  • improved data-sharing mechanisms
  • a centralized, internationally accessible database that includes complex information (i.e. histological and mechanism of action information)
  • biomarkers of organ-specific toxicity
  • improved biological information (both in vitro and in vivo) to build adverse outcome pathways and increase confidence in negative in vitro findings.

Acceptance and use depends on building confidence in the new approaches, which will be achieved by satisfying the elements described above. However, there is a critical need for outreach to regulators to achieve their international (and ideally harmonized) commitment.