The current status of exposure-driven approaches for chemical safety assessment: A cross-sector perspective
| Autor: | Emma Moore, Nichola Gellatly, M. Aggarwal, Alexander Stevens, Martijn Rooseboom, Gerald Bachler, Sally Robinson, Alan Broadmeadow, Natalie Burden, Fiona Sewell, Claire Terry |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Physiologically based pharmacokinetic modelling Agrochemical Process (engineering) 010501 environmental sciences Animal Testing Alternatives Toxicology Models Biological Risk Assessment 01 natural sciences 03 medical and health sciences Chemical safety Risk Factors Toxicity Tests Animals Humans Computer Simulation Relevance (information retrieval) 0105 earth and related environmental sciences Animal Welfare (journal) business.industry Perspective (graphical) Reproducibility of Results Environmental Exposure Toxicokinetics 030104 developmental biology Risk analysis (engineering) Models Animal business Risk assessment |
| Zdroj: | Toxicology. 389:109-117 |
| ISSN: | 0300-483X |
| Popis: | For the purposes of chemical safety assessment, the value of using non-animal (in silico and in vitro) approaches and generating mechanistic information on toxic effects is being increasingly recognised. For sectors where in vivo toxicity tests continue to be a regulatory requirement, there has been a parallel focus on how to refine studies (i.e. reduce suffering and improve animal welfare) and increase the value that in vivo data adds to the safety assessment process, as well as where to reduce animal numbers where possible. A key element necessary to ensure the transition towards successfully utilising both non-animal and refined safety testing is the better understanding of chemical exposure. This includes approaches such as measuring chemical concentrations within cell-based assays and during in vivo studies, understanding how predicted human exposures relate to levels tested, and using existing information on human exposures to aid in toxicity study design. Such approaches promise to increase the human relevance of safety assessment, and shift the focus from hazard-driven to risk-driven strategies similar to those used in the pharmaceutical sectors. Human exposure-based safety assessment offers scientific and 3Rs benefits across all sectors marketing chemical or medicinal products. The UK's National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) convened an expert working group of scientists across the agrochemical, industrial chemical and pharmaceutical industries plus a contract research organisation (CRO) to discuss the current status of the utilisation of exposure-driven approaches, and the challenges and potential next steps for wider uptake and acceptance. This paper summarises these discussions, highlights the challenges - particularly those identified by industry - and proposes initial steps for moving the field forward. |
| Databáze: | OpenAIRE |
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