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1. Meeting Report: Validation of Toxicogenomics-Based Test Systems: ECVAM-ICCVAM/NICEATM Considerations for Regulatory Use

Author

Corvi, Raffaella, Ahr, Hans-Jürgen, Albertini, Silvio, Blakey, David H., Clerici, Libero, Coecke, Sandra, Douglas, George R., Gribaldo, Laura, Groten, John P., Haase, Bernd, Hamernik, Karen, Hartung, Thomas, Inoue, Tohru, Indans, Ian, Maurici, Daniela, Orphanides, George, Rembges, Diana, Sansone, Susanna-Assunta, Snape, Jason R., Toda, Eisaku, Tong, Weida, van Delft, Joost H., Weis, Brenda, and Schechtman, Leonard M.

Published
2006

11. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens: I. Summary of pre-validation study results

Author

Uno, Yoshifumi, primary, Kojima, Hajime, additional, Omori, Takashi, additional, Corvi, Raffaella, additional, Honma, Masamistu, additional, Schechtman, Leonard M., additional, Tice, Raymond R., additional, Burlinson, Brian, additional, Escobar, Patricia A., additional, Kraynak, Andrew R., additional, Nakagawa, Yuzuki, additional, Nakajima, Madoka, additional, Pant, Kamala, additional, Asano, Norihide, additional, Lovell, David, additional, Morita, Takeshi, additional, Ohno, Yasuo, additional, and Hayashi, Makoto, additional

Published
2015
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12. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: II. Summary of definitive validation study results

Author

Uno, Yoshifumi, primary, Kojima, Hajime, additional, Omori, Takashi, additional, Corvi, Raffaella, additional, Honma, Masamistu, additional, Schechtman, Leonard M., additional, Tice, Raymond R., additional, Beevers, Carol, additional, Boeck, Marlies De, additional, Burlinson, Brian, additional, Hobbs, Cheryl A., additional, Kitamoto, Sachiko, additional, Kraynak, Andrew R., additional, McNamee, James, additional, Nakagawa, Yuzuki, additional, Pant, Kamala, additional, Plappert-Helbig, Ulla, additional, Priestley, Catherine, additional, Takasawa, Hironao, additional, Wada, Kunio, additional, Wirnitzer, Uta, additional, Asano, Norihide, additional, Escobar, Patricia A., additional, Lovell, David, additional, Morita, Takeshi, additional, Nakajima, Madoka, additional, Ohno, Yasuo, additional, and Hayashi, Makoto, additional

Published
2015
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14. The Principles of Weight of Evidence Validation of Test Methods and Testing Strategies: The Report and Recommendations of ECVAM Workshop 58a

Author

Balls, Michael, Amcoff, Patric, Bremer, Susanne, Casati, Silvia, Coecke, Sandra, Clothier, Richard, Combes, Robert, Corvi, Raffaella, Curren, Rodger, Eskes, Chantra, Fentem, Julia, Gribaldo, Laura, Halder, Marlies, Hartung, Thomas, Hoffmann, Sebastian, Schechtman, Leonard, Scott, Laurie, Spielmann, Horst, Stokes, William, Tice, Raymond, Wagner, Drew, and Zuang, Valérie

Subjects
Article
Published
2006

15. Validation of Toxicogenomics-Based Test Systems:ECVAM-ICCVAM/NICEATM Considerations for Regulatory Use

Author

CORVI RAFFAELLA, AHR Hans, ALBERTINI Silvio, BLAKEY David, CLERICI Libero, COECKE SANDRA, DOUGLAS George, GRIBALDO LAURA, GROTEN John, HAASE Bernd, HAMERNIK Karen, HARTUNG THOMAS, INOUE Tohru, INDANS Ian, MAURICI Daniela, ORPHANIDES George, REMBGES DIANA, SANSONE Susanna, SNAPE Jason, TODA Eisaku, TONG Weida, VAN DELFT Joost, WEIS Brenda, and SCHECHTMAN Leonard

Abstract

This is the report of the first workshop on the Validation of Toxicogenomics-based Test Systems held in Ispra, Italy on 11-12 December 2003. The workshop was hosted by the European Centre for the Validation of Alternative Methods (ECVAM) and organized jointly by ECVAM, the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). The primary aim of the workshop was to discuss and define principles applicable to the validation of toxicogenomics platforms as well as validation of specific toxicological test methods that incorporate toxicogenomics technologies. The workshop was viewed as an opportunity for initiating a dialogue between technological experts, regulators, and the principal validation bodies, and for identifying those factors to which the validation process would be applicable. It was felt that to do so now, as the technology is evolving and associated challenges are identified, would serve as the basis for the future validation of the technology when it reached the appropriate stage. Due to the complexity of the issue, different aspects of the validation of toxicogenomics-based test methods were covered. The three focus areas included (a) biological validation of toxicogenomics-based test methods for regulatory decision-making, (b) technical and bioinformatics aspects related to validation, and (c) validation issues as they relate to regulatory acceptance and utilization of toxicogenomics-based test methods. This report summarizes the discussions and details the recommendations for future direction and priorities., JRC.I.2-Validation of biomedical testing methods

Published
2005

16. Guidance on Good Cell Culture Practice

Author

Coecke, Sandra, primary, Balls, Michael, additional, Bowe, Gerard, additional, Davis, John, additional, Gstraunthaler, Gerhard, additional, Hartung, Thomas, additional, Hay, Robert, additional, Price, Anna, additional, Merten, Otto-Wilhelm, additional, Stokes, William, additional, Schechtman, Leonard, additional, and Stacey, Glyn, additional

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17. Points of Reference in the Validation Process

Author

Hoffmann, Sebastian, primary, Edler, Lutz, additional, Gardner, Ian, additional, Gribaldo, Laura, additional, Hartung, Thomas, additional, Klein, Christoph, additional, Liebsch, Manfred, additional, Sauerland, Stefan, additional, Schechtman, Leonard, additional, Stammati, Annalaura, additional, and Nikolaidis, Efstathios, additional

Published
2008
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18. The Principles of Weight of Evidence Validation of Test Methods and Testing Strategies

Author

Balls, Michael, primary, Amcoff, Patric, additional, Bremer, Susanne, additional, Casati, Silvia, additional, Coecke, Sandra, additional, Clothier, Richard, additional, Combes, Robert, additional, Corvi, Raffaella, additional, Curren, Rodger, additional, Eskes, Chantra, additional, Fentem, Julia, additional, Gribaldo, Laura, additional, Halder, Marlies, additional, Hartung, Thomas, additional, Hoffmann, Sebastian, additional, Schechtman, Leonard, additional, Scott, Laurie, additional, Spielmann, Horst, additional, Stokes, William, additional, Tice, Raymond, additional, Wagner, Drew, additional, and Zuang, Valérie, additional

Published
2006
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19. Guidance on Good Cell Culture Practice

Author

Coecke, Sandra, primary, Balls, Michael, additional, Bowe, Gerard, additional, Davis, John, additional, Gstraunthaler, Gerhard, additional, Hartung, Thomas, additional, Hay, Robert, additional, Merten, Otto-Wilhelm, additional, Price, Anna, additional, Schechtman, Leonard, additional, Stacey, Glyn, additional, and Stokes, William, additional

Published
2005
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21. Strategy for genotoxicity testing and stratification of genotoxicity test results—report on initial activities of the IWGT Expert Group

Author

Müller, Lutz, primary, Blakey, David, additional, Dearfield, Kerry L., additional, Galloway, Sheila, additional, Guzzie, Peggy, additional, Hayashi, Makoto, additional, Kasper, Peter, additional, Kirkland, David, additional, MacGregor, James T., additional, Parry, James M., additional, Schechtman, Leonard, additional, Smith, Andrew, additional, Tanaka, Noriho, additional, Tweats, David, additional, and Yamasaki, Hiroshi, additional

Published
2003
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27. Novel Pyrogen Tests Based on the Human Fever Reaction

Author

Hartung, Thomas, primary, Aaberge, Ingeborg, additional, Berthold, Susanne, additional, Carlin, Gunnar, additional, Charton, Emmanuelle, additional, Coecke, Sandra, additional, Fennrich, Stefan, additional, Fischer, Matthias, additional, Gommer, Martin, additional, Halder, Marlies, additional, Haslov, Kaare, additional, Jahnke, Michael, additional, Montag-Lessing, Thomas, additional, Poole, Stephen, additional, Schechtman, Leonard, additional, Wendel, Albrecht, additional, and Werner-Felmayer, Gabriele, additional

Published
2001
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28. Evaluation of the rodent micronucleus assay by a 28‐day treatment protocol: Summary of the 13th Collaborative Study by the Collaborative Study Group for the Micronucleus Test (CSGMT)/Environmental Mutagen Society of Japan (JEMS)–Mammalian Mutagenicity Study Group (MMS)

Author

Hamada, Shuichi, primary, Sutou, Sizuyo, additional, Morita, Takeshi, additional, Wakata, Akihiro, additional, Asanami, Shougo, additional, Hosoya, Satoko, additional, Ozawa, Shigenari, additional, Kondo, Koji, additional, Nakajima, Madoka, additional, Shimada, Hiroyasu, additional, Osawa, Koichi, additional, Kondo, Yasushi, additional, Asano, Norihide, additional, Sato, Sei‐ichi, additional, Tamura, Hironobu, additional, Yajima, Nobuhiro, additional, Marshall, Richard, additional, Moore, Catherine, additional, Blakey, David H., additional, Schechtman, Leonard M., additional, Weaver, James L., additional, Torous, Dorothea K., additional, Proudlock, Ray, additional, Ito, Seiichi, additional, Namiki, Chiaki, additional, and Hayashi, Makoto, additional

Published
2001
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33. Guidance on Good Cell Culture Practice.

Author

Smith, Rodney, Coecke, Sandra, Balls, Michael, Bowe, Gerard, Davis, John, Gstraunthaler, Gerhard, Hartung, Thomas, Hay, Robert, Price, Anna, Merten, Otto-Wilhelm, Stokes, William, Schechtman, Leonard, and Stacey, Glyn

Abstract

The history of cell culture teaches us that there is a need to attend to certain fundamental aspects of best practice when preparing cells for routine use. As cell culture techniques and applications become more complex it becomes increasingly necessary to be aware of the impact of poorly controlled or suboptimal cell culture procedures. The Good Cell Culture Practice guidance has been prepared to promote an awareness of a broad range of important issues in cell culture in workers coming to use cells for their work for the first time and to remind others of the fundamental aspects of good practice in cell and tissue culture. [ABSTRACT FROM AUTHOR]

Published
2007
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35. Effect of 3-aminobenzamide on the induction of toxicity and transformation by ethyl methanesulfonate and methylcholanthrene in BALB/3T3 cells.

Author

Lubet, Ronald A., McCarvill, John T., Putman, Donald L., Schwartz, Jeffery L., and Schechtman, Leonard M.

Abstract

3-Aminobenzamide, a potent inhibitor of nuclear poly ADP-ribosyl synthetase, was tested for its ability to alter the toxic and/or transforming effects of ethyl methanesulfonate, methyl methanesulfonate and 3-methylcholanthrene in BALB/3T3 clone A31-1 cells. 3-Aminobenzamide enhanced the toxic effects of both ethyl methanesulfonate and methyl methanesulfonate in a dose dependent manner, but had minimal effects on 3-methylcholanthrene induced toxicity. Similarly, 3-aminobenzamide greatly enhanced ethyl methanesulfonate induced transformation while failing to enhance the transformation of BALB/3T3 clone A31-1 cells by 3-methylcholanthrene. These results stress the importance of poly ADP-ribosyl synthetase in repair of DNA damage and the chemical induction of transformation . [ABSTRACT FROM PUBLISHER]

Published
1984

39. The JaCVAM international validation study on the in vivo comet assay: Selection of test chemicals.

Author

Morita T, Uno Y, Honma M, Kojima H, Hayashi M, Tice RR, Corvi R, and Schechtman L

Subjects
Animals, Carcinogens toxicity, DNA Damage drug effects, Databases, Factual, Dose-Response Relationship, Drug, Female, Male, Mutagens toxicity, Rats, Reproducibility of Results, Sensitivity and Specificity, Toxicity Tests, Acute, Comet Assay methods, Comet Assay standards
Abstract

The Japanese Center for the Validation of Alternative Methods (JaCVAM) sponsored an international prevalidation and validation study of the in vivo rat alkaline pH comet assay. The main objective of the study was to assess the sensitivity and specificity of the assay for correctly identifying genotoxic carcinogens, as compared with the traditional rat liver unscheduled DNA synthesis assay. Based on existing carcinogenicity and genotoxicity data and chemical class information, 90 chemicals were identified as primary candidates for use in the validation study. From these 90 chemicals, 46 secondary candidates and then 40 final chemicals were selected based on a sufficiency of carcinogenic and genotoxic data, differences in chemical class or genotoxic or carcinogenic mode of action (MOA), availability, price, and ease of handling. These 40 chemicals included 19 genotoxic carcinogens, 6 genotoxic non-carcinogens, 7 non-genotoxic carcinogens and 8 non-genotoxic non-carcinogens. "Genotoxicity" was defined as positive in the Ames mutagenicity test or in one of the standard in vivo genotoxicity tests (primarily the erythrocyte micronucleus assay). These chemicals covered various chemicals classes, MOAs, and genotoxicity profiles and were considered to be suitable for the purpose of the validation study. General principles of chemical selection for validation studies are discussed., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Published
2015
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40. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens: I. Summary of pre-validation study results.

Author

Uno Y, Kojima H, Omori T, Corvi R, Honma M, Schechtman LM, Tice RR, Burlinson B, Escobar PA, Kraynak AR, Nakagawa Y, Nakajima M, Pant K, Asano N, Lovell D, Morita T, Ohno Y, and Hayashi M

Subjects
Animals, Europe, Guidelines as Topic, Liver drug effects, Male, Rats, Rats, Sprague-Dawley, Reproducibility of Results, Societies, Scientific, Stomach drug effects, United States, Carcinogens analysis, Comet Assay methods, Comet Assay standards, DNA Damage
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., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Published
2015
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41. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: II. Summary of definitive validation study results.

Author

Uno Y, Kojima H, Omori T, Corvi R, Honma M, Schechtman LM, Tice RR, Beevers C, De Boeck M, Burlinson B, Hobbs CA, Kitamoto S, Kraynak AR, McNamee J, Nakagawa Y, Pant K, Plappert-Helbig U, Priestley C, Takasawa H, Wada K, Wirnitzer U, Asano N, Escobar PA, Lovell D, Morita T, Nakajima M, Ohno Y, and Hayashi M

Subjects
Animals, DNA Damage, Ethyl Methanesulfonate, Liver drug effects, Male, Rats, Rats, Sprague-Dawley, Stomach drug effects, Carcinogens analysis, Comet Assay methods, Comet Assay standards
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 exercise was to establish an Organisation for Economic Co-operation and Development (OECD) test guideline. The study protocol was optimized in the pre-validation studies, and then the definitive (4th phase) validation study was conducted in two steps. In the 1st step, assay reproducibility was confirmed among laboratories using four coded reference chemicals and the positive control ethyl methanesulfonate. In the 2nd step, the predictive capability was investigated using 40 coded chemicals with known genotoxic and carcinogenic activity (i.e., genotoxic carcinogens, genotoxic non-carcinogens, non-genotoxic carcinogens, and non-genotoxic non-carcinogens). Based on the results obtained, the in vivo comet assay is concluded to be highly capable of identifying genotoxic chemicals and therefore can serve as a reliable predictor of rodent carcinogenicity., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Published
2015
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42. ECVAM prevalidation of three cell transformation assays.

Author

Vanparys P, Corvi R, Aardema M, Gribaldo L, Hayashi M, Hoffmann S, and Schechtman L

Subjects
Animals, BALB 3T3 Cells, Carcinogenicity Tests standards, Mice, Animal Testing Alternatives methods, Carcinogenicity Tests methods
Abstract

A prevalidation study on the cell transformation assays in SHE cells at pH 6.7, SHE cells at pH 7.0 and Balb/c 3T3 cell line was coordinated by ECVAM focussing on issues of standardisation of protocols, within-laboratory reproducibility, test method transferability and between-laboratory reproducibility. The Validation Management Team concluded that standardised protocols are now available that should be the basis for future use. The SHE pH 6.7, and the SHE pH 7.0 protocols and the assays system themselves are transferable between laboratories, and are reproducible within- and between-laboratories. For the Balb/c 3T3 method, some clarifications and modifications to the protocol were needed to obtain reproducible results. Overall, three methods have shown to be valuable to detect rodent carcinogens.

Published
2011
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43. The international symposium on regulatory testing and animal welfare: recommendations on best scientific practices for subchronic/chronic toxicity and carcinogenicity testing.

Author

Combes R, Schechtman L, Stokes WS, and Blakey D

Subjects
Animal Testing Alternatives methods, Animals, Carcinogenicity Tests methods, Health Planning Guidelines, International Cooperation, Animal Testing Alternatives legislation & jurisprudence, Animal Welfare, Animals, Laboratory, Government Regulation, Toxicity Tests, Chronic methods
Published
2002

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