New and Emerging Technologies for Genetic Toxicity Testing

被引:53
|
作者
Lynch, Anthony M. [2 ]
Sasaki, Jennifer C. [3 ]
Elespuru, Rosalie [4 ]
Jacobson-Kram, David [5 ]
Thybaud, Veronique [6 ]
De Boeck, Marlies [7 ]
Aardema, Marilyn J. [8 ]
Aubrecht, Jiri [9 ]
Benz, R. Daniel [10 ]
Dertinger, Stephen D. [11 ]
Douglas, George R. [12 ]
White, Paul A. [13 ]
Escobar, Patricia A. [14 ]
Fornace, Albert, Jr. [15 ]
Honma, Masamitsu [16 ]
Naven, Russell T. [17 ]
Rusling, James F. [18 ]
Schiestl, Robert H. [19 ,20 ]
Walmsley, Richard M. [21 ,22 ]
Yamamura, Eiji [23 ]
van Benthem, Jan [24 ]
Kim, James H. [1 ]
机构
[1] ILSI Hlth & Environm Sci Inst, Washington, DC USA
[2] GlaxoSmithKline R&D, Ware, Herts, England
[3] Johnson & Johnson Pharmaceut Res & Dev, Raritan, NJ USA
[4] US FDA, Genom & Genet Lab, FDA CDRH OSEL, Div Biol, Silver Spring, MD USA
[5] US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[6] Vitry Alfortville Res Ctr, F-94400 Vitry Sur Seine, France
[7] Johnson & Johnson Pharmaceut Res & Dev, Div Janssen Pharmaceut NV, Genet & Exploratory Toxicol, Beerse, Belgium
[8] Procter & Gamble Co, Cincinnati, OH USA
[9] Pfizer Inc, Groton, CT 06340 USA
[10] US FDA, Ctr Drug Evaluat & Res, Off Pharmaceut Sci, Sci & Res Staff,Informat & Computat Safety Anal S, Silver Spring, MD USA
[11] Litron Labs, Rochester, NY USA
[12] Hlth Canada, Ctr Environm Hlth, Ottawa, ON K1A 0K9, Canada
[13] Hlth Canada, Mechanist Studies Div, Environm Hlth Sci & Res Div, Ottawa, ON K1A 0K9, Canada
[14] Boehringer Ingelheim Pharmaceut Inc, Toxicol & Safety Assessment, Ridgefield, CT 06877 USA
[15] Georgetown Univ, Lombardi Comprehens Canc Ctr, Washington, DC USA
[16] Natl Inst Hlth Sci, Div Genet & Mutagenesis, Tokyo, Japan
[17] Pfizer Global Res & Dev, Drug Safety R&D, Sandwich, Kent, England
[18] Univ Connecticut, Dept Chem, Storrs, CT USA
[19] Univ Calif Los Angeles, Sch Med, Los Angeles, CA USA
[20] Univ Calif Los Angeles, Sch Publ Hlth, Los Angeles, CA 90024 USA
[21] Univ Manchester, Fac Life Sci, Manchester M13 9NT, Lancs, England
[22] Gentronix Ltd, Manchester, Lancs, England
[23] Mitsubishi Tanabe Pharma Corp, Tokyo, Japan
[24] Natl Inst Publ Hlth & Environm RIVM, Lab Hlth Protect Res, Bilthoven, Netherlands
关键词
new technologies; genetic toxicity; testing; alternatives; ILSI HESI; FLOW-CYTOMETRIC ANALYSIS; PERIPHERAL-BLOOD RETICULOCYTES; VITRO MICRONUCLEUS ASSAY; LUNG EPITHELIAL-CELLS; GADD45-ALPHA-GFP INDICATOR ASSAY; DISCRIMINATE RODENT CARCINOGENS; MONITORING CHROMOSOMAL DAMAGE; EXPRESSION PROFILE ANALYSIS; VIVO COMET ASSAY; HUMAN SKIN MODEL;
D O I
10.1002/em.20614
中图分类号
X [环境科学、安全科学];
学科分类号
08 ; 0830 ;
摘要
The International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) Project Committee on the Relevance and Follow-up of Positive Results in In Vitro Genetic Toxicity (IVGT) Testing established an Emerging Technologies and New Strategies Workgroup to review the current State of the Art in genetic toxicology testing. The aim of the workgroup was to identify promising technologies that will improve genotoxicity testing and assessment of in vivo hazard and risk, and that have the potential to help meet the objectives of the IVGT. As part of this initiative, HESI convened a workshop in Washington, DC in May 2008 to discuss mature, maturing, and emerging technologies in genetic toxicology. This article collates the abstracts of the New and Emerging Technologies Workshop together with some additional technologies subsequently considered by the workgroup. Each abstract (available in the online version of the article) includes a section addressed specifically to the strengths, weaknesses, opportunities, and threats associated with the respective technology. Importantly, an overview of the technologies and an indication of how their use might be aligned with the objectives of IVGT are presented. In particular, consideration was given with regard to follow-up testing of positive results in the standard IVGT tests (i.e., Salmonella Ames test, chromosome aberration assay, and mouse lymphoma assay) to add weight of evidence and/or provide mechanism of action for improved genetic toxicity risk assessments in humans. Environ. Mol. Mutagen. 52: 205-223, 2011. (C) 2010 Wiley-Liss, Inc.
引用
收藏
页码:205 / 223
页数:19
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