Nanotechnologie - eine Herausforderung für die Arbeitsmedizin
In: Aktuelle Dermatologie: Organ der Arbeitsgemeinschaft Dermatologische Onkologie ; Organ der Deutschen Gesellschaft für Lichtforschung, Band 37, Heft 3, S. 81-86
ISSN: 1438-938X
4 Ergebnisse
Sortierung:
In: Aktuelle Dermatologie: Organ der Arbeitsgemeinschaft Dermatologische Onkologie ; Organ der Deutschen Gesellschaft für Lichtforschung, Band 37, Heft 3, S. 81-86
ISSN: 1438-938X
In: Piersma , A H , Burgdorf , T , Louekari , K , Desprez , B , Taalman , R , Landsiedel , R , Barroso , J , Rogiers , V , Eskes , C , Oelgeschläger , M , Whelan , M , Braeuning , A , Vinggaard , A M , Kienhuis , A , van Benthem , J & Ezendam , J 2018 , ' Workshop on acceleration of the validation and regulatory acceptance of alternative methods and implementation of testing strategies ' , Toxicology in Vitro , vol. 50 , pp. 62-74 . https://doi.org/10.1016/j.tiv.2018.02.018
This report describes the proceedings of the BfR-RIVM workshop on validation of alternative methods which was held 23 and 24 March 2017 in Berlin, Germany. Stakeholders from governmental agencies, regulatory authorities, universities, industry and the OECD were invited to discuss current problems concerning the regulatory acceptance and implementation of alternative test methods and testing strategies, with the aim to develop feasible solutions. Classical validation of alternative methods usually involves one to one comparison with the gold standard animal study. This approach suffers from the reductionist nature of an alternative test as compared to the animal study as well as from the animal study being considered as the gold standard. Modern approaches combine individual alternatives into testing strategies, for which integrated and defined approaches are emerging at OECD. Furthermore, progress in mechanistic toxicology, e.g. through the adverse outcome pathway approach, and in computational systems toxicology allows integration of alternative test battery results into toxicity predictions that are more fine-tuned to the human situation. The road towards transition to a mechanistically-based human-focused hazard and risk assessment of chemicals requires an open mind towards stepping away from the animal study as the gold standard and defining human biologically based regulatory requirements for human hazard and risk assessment.
BASE
In: Burgdorf , T , Piersma , A H , Landsiedel , R , Clewell , R , Kleinstreuer , N , Oelgeschläger , M , Desprez , B , Kienhuis , A , Bos , P , de Vries , R , de Wit , L , Seidle , T , Scheel , J , Schönfelder , G , van Benthem , J , Vinggaard , A M , Eskes , C & Ezendam , J 2019 , ' Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - Evolution versus revolution ' , Toxicology in Vitro , vol. 59 , pp. 1-11 . https://doi.org/10.1016/j.tiv.2019.03.039
At a joint workshop organized by RIVM and BfR, international experts from governmental institutes, regulatory agencies, industry, academia and animal welfare organizations discussed and provided recommendations for the development, validation and implementation of innovative 3R approaches in regulatory toxicology. In particular, an evolutionary improvement of our current approach of test method validation in the context of defined approaches or integrated testing strategies was discussed together with a revolutionary approach based on a comprehensive description of the physiological responses of the human body to chemical exposure and the subsequent definition of relevant and predictive in vitro, in chemico or in silico methods. A more comprehensive evaluation of biological relevance, scientific validity and regulatory purpose of new test methods and assessment strategies together with case studies that provide practical experience with new approaches were discussed as essential steps to build up the necessary confidence to facilitate regulatory acceptance.
BASE
There has been a conceptual shift in toxicological studies from describing what happens to explaining how the adverse outcome occurs, thereby enabling a deeper and improved understanding of how biomolecular and mechanistic profiling can inform hazard identification and improve risk assessment. Compared to traditional toxicology methods, which have a heavy reliance on animals, new approaches to generate toxicological data are becoming available for the safety assessment of chemicals, including high-throughput and high-content screening (HTS, HCS). With the emergence of nanotechnology, the exponential increase in the total number of engineered nanomaterials (ENMs) in research, development, and commercialization requires a robust scientific approach to screen ENM safety in humans and the environment rapidly and efficiently. Spurred by the developments in chemical testing, a promising new toxicological paradigm for ENMs is to use alternative test strategies (ATS), which reduce reliance on animal testing through the use of in vitro and in silico methods such as HTS, HCS, and computational modeling. Furthermore, this allows for the comparative analysis of large numbers of ENMs simultaneously and for hazard assessment at various stages of the product development process and overall life cycle. Using carbon nanotubes as a case study, a workshop bringing together national and international leaders from government, industry, and academia was convened at the University of California, Los Angeles, to discuss the utility of ATS for decision-making analyses of ENMs. After lively discussions, a short list of generally shared viewpoints on this topic was generated, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. © 2013 American Chemical Society.
BASE