Ersatz- und Ergänzungsmethoden zum Tierversuch in der toxikologischen Sicherheitsprüfung von Chemikalien, Arzneimitteln und Kosmetika in Deutschland
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Beschreibung
Animals are used for scientific purposes in a range of different research areas, including applications in area of toxicological safety testing. The toxicology safety assessment aims to determine the degree to which substances are non-hazardous for humans, animals, and the environment. Despite their usefulness, animal experiments shall be reduced to the indispensable minimum (§ 7 German animal welfare act). This requirement may be met by the increased use and application of replacement and complementary technologies (alternative methods).
In the present work, a literature research and anonymized qualitative systemizing semi-structured expert interviews were used to identify and evaluate alternative methods for animal experiments in regulatory toxicology safety testing that are currently available for chemicals, human and veterinary medicinal products, as well as cosmetics. Furthermore, the current status with regard to the application of these alternative methods, and opportunities to increase their implementation are discussed. Experts were selected from the private and academic sector and included governmental authorities and stakeholder groups.
The results indicate that alternative methods are available for use in almost all fields of toxicology safety assessment, which either could partially or completely replace the animal experiment. The experts consider the use of alternative methods to be economical and timesaving, and thus favour the replacement of animal experiments, at least in part. However, the publicly available data about the actual use of alternative methods in toxicological safety testing is heterogeneous and limited. Public data availability seems to be high in research on chemicals, but still insufficient with regard to toxicology research in human and veterinary medicinal products, as well as with regard to the safety testing of cosmetic products.
Substantial capability for methodological development that aims to avoid animal testing is seen in the use of in silico methods and strategies that combine existing data from animal experiments with in vitro, ex vivo as well as in silico methods. A pivotal concern is the transferability of results based on alternative methods to human individuals. Yet, there are multiple approaches how the transferability of these methods could be improved, which would increase their implementation. Both, the legal structure and the infrastructure for a higher implementation of alternative methods exist, but they should be used more extensively.
The German Centre for the Protection of Laboratory Animals (Bf3R) represents an important component in this regard. Bf3R has a range of tasks and strategic goals that can strengthen the implementation of alternative methods, yet, surprisingly, the center and its resources and services were not widely known to the experts interviewed. Therefore, strategies to raise the awareness of stakeholders should focus on the promotion of services and resources offered by the Bf3R. Furthermore, efforts to integrate a national reference center for the validation of alternative methods to animal testing are recommended in Germany. Only knowledge transfer in the field of alternative methods and the increased use and enhanced recognition and validation of these alternative methods will facilitate the development of an exit strategy to eliminate animal experiments in regulatory toxicological safety testing, comparable to that developed by the government of the Netherlands.
The findings of this study illustrate that the current situation is not yet optimal and, in some aspects, remains unsatisfactory. However, a wide range of possible approaches to resolve critical issues is identified, which can be recommended for implementation in future applications.
Autor*in
Ronja Burmeister
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Kosmetika Pharmakologie Tierschutz Tierversuche Toxikologie