| Content Provider |
World Health Organization (WHO)-Global Index Medicus |
| Author |
Uno, Yoshifumi Kojima, Hajime Omori, Takashi Corvi, Raffaella Honma, Masamistu Schechtman, Leonard M. Tice, Raymond R. Burlinson, Brian Escobar, Patricia A. Kraynak, Andrew R. Nakagawa, Yuzuki Nakajima, Madoka Pant, Kamala Asano, Norihide Lovell, David Morita, Takeshi Ohno, Yasuo Hayashi, Makoto |
| Spatial Coverage |
United States Europe |
| Description |
Author Affiliation: Uno Y ( Mitsubishi Tanabe Pharma Co., Chiba, Japan. Electronic address: Uno.Yoshifumi@ma.mt-pharma.co.jp.); Kojima H ( National Institute of Health Sciences, Tokyo, Japan.); Omori T ( Kobe University Hospital (formerly Doshisha University, Kyoto), Kobe, Japan.); Corvi R ( Joint Research Centre of the European Commission, Ispra, Italy.); Honma M ( National Institute of Health Sciences, Tokyo, Japan.); Schechtman LM ( Innovative Toxicology Consulting, LLC, FL, USA.); Tice RR ( National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.); Burlinson B ( Huntingdon Life Sciences, Cambs, UK.); Escobar PA ( Boehringer Ingelheim Pharmaceuticals Inc., CT, USA.); Kraynak AR ( Merck Research Laboratories, PA, USA.); Nakagawa Y ( Hatano Research Institute, Food Drug Safety Center, Kanagawa, Japan.); Nakajima M ( University of Shizuoka, Shizuoka, Japan.); Pant K ( BioReliance, MD, USA.); Asano N ( Kinki University, Osaka, Japan.); Lovell D ( St. George's, University of London, London, UK.); Morita T ( National Institute of Health Sciences, Tokyo, Japan.); Ohno Y ( National Institute of Health Sciences, Tokyo, Japan.); Hayashi M ( Biosafety Research Center, Foods, Drugs and Pesticides, Shizuoka, Japan.) |
| Abstract |
The in vivo rodent alkaline comet assay (comet assay) is used internationally to investigate the in vivo genotoxic potential of test chemicals. This assay, however, has not previously been formally validated. The Japanese Center for the Validation of Alternative Methods (JaCVAM), with the cooperation of the U.S. NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)/the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the European Centre for the Validation of Alternative Methods (ECVAM), and the Japanese Environmental Mutagen Society/Mammalian Mutagenesis Study Group (JEMS/MMS), organized an international validation study to evaluate the reliability and relevance of the assay for identifying genotoxic carcinogens, using liver and stomach as target organs. The ultimate goal of this validation effort was to establish an Organisation for Economic Co-operation and Development (OECD) test guideline. The purpose of the pre-validation studies (i.e., Phase 1 through 3), conducted in four or five laboratories with extensive comet assay experience, was to optimize the protocol to be used during the definitive validation study. |
| File Format |
HTM / HTML |
| ISSN |
13835718 |
| e-ISSN |
18793592 |
| Journal |
Mutation Research/Genetic Toxicology and Environmental Mutagenesis |
| Volume Number |
786-788 |
| Language |
English |
| Publisher |
Elsevier |
| Publisher Date |
2015-07-01 |
| Publisher Place |
Netherlands |
| Access Restriction |
Open |
| Subject Keyword |
Stomach Research Support, Non-u.s. Gov't Discipline Genetics Liver Discipline Biochemistry Rats, Sprague-dawley Guidelines As Topic Comet Assay Drug Effects Dna Damage Reproducibility Of Results Carcinogens Animals Societies, Scientific Validation Studies |
| Content Type |
Text |
| Resource Type |
Article |
| Subject |
Genetics Health, Toxicology and Mutagenesis |
