Strategy for genotoxicity testing: Hazard identification and risk assessment in relation to in vitro testing

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 627, Issue 1, 2007, Pages 41-58

  Thybaud, V ^a   Aardema, M ^b   Clements, J ^c   Dearfield, K ^d   Galloway, S ^e   Hayashi, M ^f   Jacobson Kram, D ^g   Kirkland, D ^c   MacGregor, J T ^h   Marzin, D ⁱ   Ohyama, W ^j   Schuler, M ^k   Suzuki, H ^l   Zeiger, E ^m  

^a SANOFI   (France)

^b PROCTER AND GAMBLE COMPANY   (United States)

^c UK   (United Kingdom)

^d U S DEPARTMENT OF AGRICULTURE   (United States)

^e MERCK RESEARCH LABORATORIES   (United States)

^f NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^g CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^h Toxicology Consulting Services   (United States)

ⁱ INSTITUT PASTEUR DE LILLE   (France)

^j YAKULT CENTRAL INSTITUTE FOR MICROBIOLOGICAL RESEARCH   (Japan)

^k PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^l N   (Japan)

^m Errol Zeiger Consulting   (United States)

more..

Author keywords

Genotoxicity; Hazard identification; Risk assessment; Testing strategy

Indexed keywords

DNA; POISON;

ARTICLE; CARCINOGENIC ACTIVITY; CHROMOSOME ABERRATION; CYTOGENETICS; CYTOTOXICITY; DNA DAMAGE; FOLLOW UP; GENETIC DAMAGE; GENETIC TOXICOLOGY; GENOTOXICITY; GOVERNMENT; HAZARD ASSESSMENT; HEALTH; HEALTH HAZARD; HUMAN; IN VITRO STUDY; INDUSTRY; MUTAGENIC ACTIVITY; MUTATION RATE; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; TUMOR;

ANIMALS; CHROMOSOME ABERRATIONS; CYTOGENETIC ANALYSIS; DNA; DOSE-RESPONSE RELATIONSHIP, DRUG; FOLLOW-UP STUDIES; HUMANS; MITOTIC SPINDLE APPARATUS; MUTAGENICITY TESTS; MUTAGENS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT;

EID: 33846165551     PISSN: 13835718     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2006.10.003     Document Type: Article

References (45)

1. COM (Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment), COM guidance on a strategy for testing of chemicals for mutagenicity, United Kingdom, December 2000. (http://www.advisorybodies.doh.gov.uk/com/).
2. Dearfield K.L., Cimino M.C., McCarroll N.E., Mauer I., and Valcovic L.R. Genotoxicity risk assessment: a proposed classification strategy. Mutat. Res. 521 (2002) 121-135
3. FDA, Toxicological Principles for the Safety of Food Ingredients. IV.C.1. Short-Term Tests for Genetic Toxicity, Redbook, 2000.
4. FDA, Guidance for Industry Recommended Approaches to Integration of Genetic Toxicology Study Results. Draft Guidance. Genotoxicity. Center for Drug Evaluation and Research, November 2004.
5. Health Protection Board (Canada). The Assessment of Mutagenicity. Health Protection Branch Mutagenicity Guidelines. Environ. Mol. Mutagen. 21 (1992) 15-37
6. ICH (International Cooperation on Harmonization), ICH Harmonized Tripartite Guideline. S2A. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals, July, 1995. (http://www.ich.org).
7. ICH (International Cooperation on Harmonization), ICH Harmonized Tripartite Guideline. S2B. Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals, July, 1997. (http://www.ich.org).
8. Council directive concerning the placing of plant protection products on the market (91/414/CEE), 15 July 2001.
9. Kirkland D.J. Genetic toxicology testing requirements: Official and unofficial views from Europe. Environ. Mol. Mutagen. 21 (1993) 8-14
10. Kirkland D., Aardema M., Henderson L., and Muller L. Evaluation of the ability of a battery of three genotoxicity tests to discriminate rodent carcinogens and non-carcinogens. I. Sensitivity, specificity and relative predictivity. Mutat. Res. 584 (2005) 1-256
11. Kramers P.G.N., Knaap A.G.A.C., van der Heijden C.A., Taalman M.R.D.F., and Mohn G.R. Role of genotoxicity assays in the regulation of chemicals in The Netherlands: considerations and experiences. Mutagenesis 6 (1991) 487-493
12. OECD (Organisation for Economic Co-operation and Development), OECD Guidelines for Testing of Chemicals. Introduction to the OECD Guidelines on genetic toxicology testing and guidance on the selection and application of assays, OECD, Paris, France, 1986.
13. Sofuni T. Japanese guidelines for mutagenicity testing. Environ. Mol. Mutagen. 21 (1993) 2-7
14. Zeiger E. Identification of rodent carcinogens and noncarcinogens using genetic toxicity tests: premises, promises, and performance. Regul. Toxicol. Pharmacol. 28 (1999) 85-95
15. TGD, Technical Guidance Document, second ed., European Chemicals Bureau, Joint Research Centre, Italy, December 2003 (http://ecb.jrc.it/new-chemicals/documents), 2003.
16. Müller L., Blakey D., Dearfield K.L., Galloway S., Guzzie P., Hayashi M., Kasper P., Kirkland D., MacGregor J.T., Parry J.M., Schechtman L., Schmidt A., Tanaka N., Tweats D., and Yamasaki H. Strategy for genotoxicity testing and stratification of genotoxicity test results-report on initial activities of the IWGT Expert Group. Mutat. Res. 540 (2003) 177-181
17. Approaches to determining the mutagenic properties of chemicals: risk to future generations, Subcommittee On Environmental Mutagenesis, Committee to Coordinate Toxicology and Related Programs, U.S. Department of Health Education and Welfare (DHEW), Washington, D.C., 1977, pp. 1-58. Also published as: W.G. Flamm, L.R. Valcovic, F.J. deSerres, W. D'Aguanno, L. Fishbein, S. Green, H.V. Malling, V. Mayer, M. Prival, G. Wolff, E. Zeiger. Approaches to determining the mutagenic properties of chemicals: risk to future generations. J. Environ. Pathol. Toxicol. 1 (1977) 301-352.
18. Bridges B.A. ICPEMC Perspectives on the scientific basis of risk assessment in genetic toxicology. In: Oftedal P., and Brogger A. (Eds). Risk and Reason: Risk Assessment in Relation to Environmental Mutagens and Carcinogens (1986), Alan R. Liss, New York 175-182
19. Brusick D.J. Methods for Genotoxic Risk Assessment (1994), Lewis Publishers, CRC Press, Boca Raton, FL
20. Lewtas J., DeMarini D.M., Favor J., Layton D.W., MacGregor J.T., Ashby J., Lohman P.H.M., Haynes R.H., and Mendelsohn M.L. Risk characterization strategies for genotoxic environmental agents. In: Brusick D.J. (Ed). Methods for Genotoxic Risk Assessment (1994), Lewis Publishers, CRC Press, Boca Raton, FL 125-169
21. National Research Council (NRC). Risk assessment in the federal government (1983), National Research Council, National Academy Press, Washington, D.C.
22. Macgregor J.T., Casciano D., and Müller L. Strategies and testing methods for identifying mutagenic risks. Mutat. Res. 455 (2000) 3-21
23. U.S. Environmental Protection Agency (EPA), Guidelines for carcinogen risk assessment, EPA/630/P-03/001F, March 2005 (http://www.epa.gov/cancerguidelines).
24. Dearfield K.L., and Moore M.M. Use of genetic toxicology information for risk assessment. Environ. Mol. Mutagen. 46 (2005) 236-245
25. U.S. Environmental Protection Agency (EPA), Supplemental guidance for assessing cancer susceptibility from early-life exposure to carcinogens, EPA/630/R-03/003F, March 2005 (http://www.epa.gov/cancerguidelines).
26. Jacobson-Kram D., and Jacobs A. Use of genotoxicity data to support clinical trial or positive genetox findings on a candidate pharmaceutical or impurity ... Now what?. Int. J. Toxicol. 24 (2005) 129-134
27. FDA (Food and Drug Administration) CDER (Center for Drug Evaluation and Research), Guidance for industry and review staff: recommended approaches to integration of genetic toxicology study results, January 2006.
28. U.S. Environmental Protection Agency (EPA), Environmental Protection Agency. Guidelines for mutagenicity risk assessment, Washington, DC, Fed Register 51 (1986) 34006-34012.
29. Rhomberg L., Dellarco V., Siegel-Scott C., Dearfield K., and Jacobson-Kram D. A quantitative estimation of the genetic risk associated with the induction of heritable translocations at low-dose exposure: ethylene oxide as an example. Environ. Mol. Mutagen. 16 (1990) 104-125
30. Dearfield K.L., Douglas G.R., Ehling U.H., Moore M.M., Sega G.A., and Brusick D.J. Acrylamide: a review of its genotoxicity and an assessment of heritable genetic risk. Mutat. Res. 330 (1995) 71-99
31. Cimino M.C. Comparative overview of current international strategies and guidelines for genetic toxicology testing for regulatory purposes. Environ. Mol. Mutagen. 47 (2006) 362-390
32. Snyder R.D., and Green J.W. A review of the genotoxicity of marketed pharmaceuticals. Mutat. Res. 488 (2001) 151-169
33. Kirkland D.J., and Müller L. Interpretation of the biological relevance of genotoxicity test results: the importance of thresholds. Mutat. Res. 464 (2000) 137-147
34. Müller L., and Kasper P. Human biological relevance and the use of threshold-arguments in regulatory genotoxicity assessment: experience with pharmaceuticals. Mutat. Res. 464 (2000) 19-34
35. US FDA, Center for Drug Evaluation and Research (CDER), Guidance for Industry: Safety Testing of Drug Metabolites. Draft, June 2005.
36. Nestmann E.R., Bryant D.W., and Carr C.J. Toxicological significance of DNA adducts: summary of discussions with an expert panel. Regul. Toxicol. Pharmacol. 24 (1996) 9-18
37. Madle S., Von der Hude W., Broschinski L., and Jänig G.R. Threshold effects in genetic toxicology: perspective of chemicals regulation in Germany. Mutat. Res. 464 (2000) 117-121
38. Kirsch-Volders M., Vanhauwaert A., Eichenlaub-Ritter U., and Decordier I. Indirect mechanism of genotoxicity. Toxicol. Lett. 140/141 (2003) 63-74
39. Moore M.M., Honma M., Clements J., Bolcsfoldi G., Burlinson B., Cifone M., Clarke J., Delongchamp R., Durward R., Fellows M., Gollapudi B., Hou S., Jenkinson P., Lloyd M., Majeska J., Myhr B., O'Donovan M., Omori T., Riach C., San R., Stankowski Jr. L.F., Thakur A.K., Van Goethem F., Wakuri S., and Yoshimura I. Mouse lymphoma thymidine kinase gene mutation assay: mouse lymphoma thymidine kinase gene mutation assay: follow-up meeting of the international workshop on genotoxicity testing - Aberdeen, Scotland, 2003 - assay acceptance criteria, positive controls, and data evaluation. Environ. Mol. Mutagen. 47 (2006) 1-5
40. McCarroll N.E., Protzel A., Ioannou Y., Stack H.F., Jackson M.A., Waters M.D., and Dearfield K.L. A survey of EPA/OPP and open literature on selected pesticide chemicals. III. Mutagenicity and carcinogenicity of benomyl and carbendazim. Mutat. Res. 512 (2002) 1-35
41. B.H. Margolin, K.J. Risko, The statistical analysis of in vivo genotoxicity data: case studies of the rat hepatocyte UDS and mouse bone marrow micronucleus assay, in: J. Ashby, et al. (Eds.), Evaluation of Short-Term Tests for Carcinogens. Report of the International Program on Chemical Safety's Collaborative Study on In vivo Assays, vol. 1, Cambridge University Press, Cambridge, pp. 129-142.
42. Hayashi M., Yoshimura I., Sofuni T., and Ishidate Jr. M. A procedure for data analysis of the rodent micronucleus test involving a historical control. Environ. Mol. Mutagen. 13 (1989) 347-356
43. Brusick D., Ashby J., de Serres E., Lohman P.H.M., Matsushima T., Matter B.E., Mendelsohn M.L., and Waters M.D. Weight-of-evidence scheme for evaluation and interpretation of short-term results. In: Ramel C., Lambert B., and Magnusson J. (Eds). Genetic Toxicology of Environmental Chemicals, Part B: Genetic Effects and Applied Mutagenesis (1986), Alan R. Liss, New York 121-129
44. Brusick D.J., Ashby J., de Serres E.J., Lohman P.H.M., Matsushima T., Matter B.E., Mendelsohn M.L., Moore D.H., Nesnow S., and Waters M.D. A method for combining and comparing short-term genotoxicity test data. Mutat. Res. 266 (1992) 1-60
45. J.M. Parry, A. Sarrif (Eds.), Dose-response and threshold-mediated mechanisms in mutagenesis, Mutat. Res. Spec. Issue 465 (1999) 1-160.