This article has been reviewed according to Science X's editorial process and policies. Editors have highlighted the following attributes while ensuring the content's credibility: For many years, the European Union has pursued a policy aimed at the replacement, reduction and refinement of animal testing (the 3Rs principle). To put the ethical principle of the 3Rs into practice, the European Commission has published a roadmap for the gradual phaseout of animal testing in the safety assessment of chemicals.
The ASPA (Alternative Safety Profiling Algorithm) workflow is a central, structured tool for fully animal-free, risk-based safety assessment. It is one of the most specific scientific concepts of modern Next Generation Risk Assessment (NGRA), a field in which new methods and software solutions have been developed to put the roadmap into practice. The workflow was developed by the ASPIS cluster, a collaboration of the projects ONTOX, PrecisionTox and RISK-HUNT3R.
Researchers at Fraunhofer ITEM have played a key role in developing the ASPA workflow within the RISK-HUNT3R project. "The ASPA workflow is a transparent, reproducible and modular approach to animal-free Next Generation Risk Assessment of chemicals. It enables us to assess chemical risks using animal-free in silico and in vitro methods," says Sylvia Escher, a research scientist at Fraunhofer ITEM.
"With ASPA, we transparently integrate biological activity data from a range of new approach methodologies (NAMs), information on human uptake and exposure, and toxicological mechanisms. The aim is to enable scientifically sound safety assessments that can be readily used by regulatory authorities and to reproducibly assess the risks posed by chemicals on the basis of three main pillars: toxicokinetics (absorption, distribution, metabolism and excretion), hazard and exposure." NAMs are regarded as key technologies for the future safety assessment of chemicals. These include human-relevant cellular test systems, such as in vitro and ex vivo models, as well as computer-based models.
Together, they form the foundation of NGRA. The ASPA workflow supports safety assessments. It comprises around 55 assessment elements, providing a multistage, modular strategy for risk analysis.
The aim of ASPA is to make safety assessments fully transparent for the recipient—such as a regulatory authority—by showing which steps and decisions led to the final outcome. ASPA requires precise justification of interim decisions, which in turn necessitates the continuous assessment of uncertainties. This complex process is supported by the ASPA-assist software, which guides users step by step through ASPA's 55 assessment modules and facilitates the reporting process in a reproducible and standardized manner.
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