Press Release
Innovative approach to acute oral toxicity assessment provides a transparent pathway to replace animal testing, strengthen regulatory compliance
BRUSSELS—The Animal-Free Safety Assessment (AFSA) Collaboration has launched a groundbreaking new tool designed to help industry and regulators implement in both principle and practice the use of animal testing only as a last resort. The science-based decision tree offers a practical framework for determining when animal-free test methods can be used in place of lethal dose tests to assess acute oral toxicity.
Although several global chemical regulations formally mandate the principle that animal testing should only be used as a last resort, implementation has remained inconsistent in practice. Animal testing is often carried out due to uneven guidance, ambiguous definitions and regulatory uncertainty.
“The Animal-Free Safety Assessment Collaboration’s decision tree for acute oral toxicity directly addresses the last resort principle by providing a structured, transparent and scientifically grounded workflow to guide registrants through an evaluation of available non-animal methods before any animal studies are considered,” said Giorgia Pallocca, senior programme director, regulatory science at Humane World for Animals.
Acute oral toxicity assessment remains a common requirement in chemical safety evaluation and is often carried out through lethal dose tests which can cause significant animal suffering whilst offering limited scientific insight.
The decision tree brings together existing information, physiochemical data, computational models and other knowledge to determine whether acute oral toxicity can be assessed through animal-free methods instead of lethal dose tests. The decision tree framework has potential global relevance. The recent publication describes it application in the EU, offering practical support and alignment with the recent roadmap towards phasing out animal testing.
“This framework brings clarity to a process that has long been fragmented and difficult to navigate,” said Jay Ingram, managing director, chemicals at Humane World for Animals. “By consolidating existing scientific and regulatory information into a coherent structure, the decision tree approach makes decision-making traceable, reproducible and scientifically robust – creating a shared language for both industry and regulators.”
A similar framework is being developed for endpoints where non-animal methods are already mature, validated and accepted, including skin sensitisation, eye irritation and skin corrosion. These endpoints represent immediate opportunities for regulatory transition, demonstrating that non-animal methods are not aspirational, but ready for widespread and consistent use.
Notes to editor:
- The full paper can be found here: A decision tree for acute oral toxicity: Implementing the last resort requirement in practice
- The initial publication can be found here: The Decision Tree approach as a strategy for the global phase out of animal testing for acute and local toxicity for chemicals: recommendations from an expert workshop
- About the Decision Tree Framework: the Decision Tree framework organises testing strategies into modular workflows aligned with Integrated Approaches to Testing and Assessment (IATA) principles. Each module clearly maps available cell-based and computational methods alongside animal-based approaches, with direct references to relevant OECD Test Guidelines and transparent documentation of each method’s applicability and limitations.
- The Decision Tree framework can support the ongoing REACH revision through:
- Guidance integration: Consolidating information on non-animal methods, waivers and bridging principles within REACH-related guidance
- Annex updates: Informing revisions to standard information requirements and adaptation criteria
- Testing proposals: Serving as a scientific foundation for justification documents in a reformed testing proposal process
- Annex XI implementation: Enabling scientifically justified adaptations under both current and revised regulatory frameworks
About the Animal-Free Safety Assessment (AFSA) Collaboration
The Animal-Free Safety Assessment (AFSA) Collaboration is a global, multidisciplinary initiative that advocates for a shift toward science-driven, non-animal safety assessment strategies. One of its core priorities is the effective implementation of legislative requirements that support such a shift, including increasing enforcement and accountability of REACH’s last resort requirement.
Media Contact
Uma Lanka, ulanka@humaneworld.org, +44 7715 293038