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Validation of the 21 st Century Toxicology Toolbox : Challenges , Opportunities , and the Way Forward
| Content Provider | Semantic Scholar |
|---|---|
| Author | Stokes, William S. Strickland, Judy Casey, Warren |
| Copyright Year | 2012 |
| Abstract | Consumers and workers are exposed to a wide range of naturally occurring and manmade chemicals and products in foods, medicines, consumer products, pesticides, water, air, and other sources. Safety testing is required by regulatory authorities to determine if chemicals and products are safe or if they may produce adverse health effects to people, animals, and the environment. Such testing determines the nature and severity of health hazards that might be produced by accidental or intentional exposures, and it is used as the basis for hazard labeling or to establish safe levels of exposure. Safety assessments traditionally have used animal models, but in recent years a number of new in vitro and in vivo models have been developed and accepted that have significantly reduced, refined (less or no pain and distress), and replaced animal use (Stokes and Wind, 2010b). Regulatory acceptance of these new alternative methods was supported by scientific validation studies that characterized the usefulness and limitations of the new proposed methods for identifying specific hazards. Validation studies provided the information needed by regulatory authorities to determine that using the proposed test method would provide equivalent or improved protection of people, animals, and/or the environment (Stokes and Schechtman, 2007; Birnbaum and Stokes, 2010). Several national validation centers and committees are charged with evaluating the scientific validity of new test methods and/or conducting test method validation studies. Much of the recent progress in the acceptance of alternative test methods has resulted from the efforts of these organizations. In the United States, these include the National toxicology Program's (NTP) Interagency Center for the Evaluation of Alternative Methods (NICEATM), and its Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM, 2008, 2010; Birnbaum and Stokes, 2010; Stokes and Wind, 2010c). Other organizations include the European Centre for the Validation of Alternative Methods (ECVAM), the Japanese Center for the Validation of Alternative Methods (JaCVAM), and the Korean Center for the Validation of Alternative Methods (KoCVAM). At least 43 alternative methods have now been adopted by national and international regulatory authorities (NICEATM, 2011). More recently, new research initiatives have focused on a systems biology approach to understanding and detecting the molecular, genetic, structural, and cellular perturbations that may lead to adverse health outcomes. Referred to as the 21st Century toxicology toolbox, these include a wide range of applications, or tools, that incorporate toxicogenomics, metabolomics, proteomics, cell based assays, biochemical activity profiles, and computational models. These tools are now being used to create complex biological activity profiles for specific chemicals, with an expectation that these profiles eventually will predict toxicity and safety without the use of animals. this paper discusses the emergence and application of new systems Validation of the 21 Century Toxicology Toolbox: Challenges, Opportunities, and the Way Forward William S. Stokes 1, Judy Strickland 2, and Warren Casey 1 1National toxicology Program Interagency Center for the evaluation of Alternative toxicological Methods, Division of the National toxicology Program, National Institute of environmental Health Sciences, National Institutes of Health, Department of Health and Human Services, Research Triangle Park, NC, USA; 2Integrated laboratory Systems, Inc., Research Triangle Park, NC, USA |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | https://ntp.niehs.nih.gov/iccvam/meetings/8wc/ms/323328_stokes22-508.pdf |
| Alternate Webpage(s) | http://iccvam.niehs.nih.gov/meetings/8WC/ms/323328_Stokes22-508.pdf |
| Alternate Webpage(s) | http://www.altex.ch/resources/323328_Stokes221.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
