According to the European Commission, a newly published roadmap outlines the gradual phase-out of animal testing in chemical safety assessments, driving a major shift toward animal-free methods like the ASPA workflow developed within the EU-funded RISK-HUNT3R project and supported by the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM.
The ASPA Workflow in Next Generation Risk Assessment
The ASPA (Alternative Safety Profiling Algorithm) workflow serves as a transparent, reproducible, and modular approach to animal-free Next Generation Risk Assessment (NGRA), according to Sylvia Escher, a research scientist at Fraunhofer ITEM. Escher states that the tool integrates biological activity data from new approach methodologies (NAMs), human uptake and exposure details, and toxicological mechanisms to enable scientifically sound safety evaluations based on toxicokinetics, hazard, and exposure.
Role of NAMs and Toxicokinetic PBK Models
New approach methodologies, including human-relevant cellular test systems and computer-based models, form the technical foundation of NGRA. Fraunhofer ITEM has advanced this framework by developing physiologically based kinetic (PBK) models. These mathematical tools translate human absorption, distribution, metabolism, and excretion (ADME) processes into equations using anatomical data and substance-specific parameters, as reported by institute researchers.
Pro tip: When building modern safety dossiers, researchers can utilize the ASPA-assist software to step through the workflow’s roughly 55 assessment modules, ensuring standardized and reproducible reporting for regulatory bodies.
Bridging Research and Regulatory Practice
To test these models in real-world scenarios, Fraunhofer ITEM researchers combined high-throughput in vitro assays, biokinetic modeling, and machine learning for an OECD IATA case study. By analyzing extensive omics data, the team evaluated cellular changes to prioritize substances with potential systemic toxicity at an early stage. Escher notes that while many NAMs are scientifically advanced, the primary challenge remains continuous validation so that regulatory authorities fully accept and integrate them.
Did you know? Read-across is a core NGRA tool that avoids animal testing by transferring safety data from well-studied chemicals to structurally similar, less-studied substances with comparable mechanisms of action.
Frequently Asked Questions
What is the ASPA workflow?
According to Fraunhofer ITEM, ASPA is a transparent, modular decision algorithm comprising roughly 55 assessment elements that guides users through animal-free chemical safety evaluations.
How do PBK models work?
Physiologically based kinetic models are mathematical tools that calculate how the human body absorbs, distributes, metabolizes, and excretes chemical substances based on anatomical data.
Does the EU roadmap mean an immediate ban on animal testing?
No, the European Commission roadmap initiates a coordinated regulatory transition rather than an immediate ban, focusing on the validation and acceptance of alternative methods.
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