Mutagenicity testing for chemical risk assessment: Update of the WHO/IPCS Harmonized Scheme

Mutagenesis

Volumn 24, Issue 4, 2009, Pages 341-349

  Eastmond, David A ^a   Hartwig, Andrea ^b   Anderson, Diana ^c   Anwar, Wagida A ^d   Cimino, Michael C ^e   Dobrev, Ivan ^f   Douglas, George R ^g   Nohmi, Takehiko ^h   Phillips, David H ⁱ   Vickers, Carolyn ^j  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b TECHNISCHE UNIVERSITÄT BERLIN   (Germany)

^c UNIVERSITY OF BRADFORD   (United Kingdom)

^d AIN SHAMS UNIVERSITY   (Egypt)

^e U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

^f FRAUNHOFER INSTITUTE FOR TOXICOLOGY AND EXPERIMENTAL MEDICINE   (Germany)

^g Environmental Health Center   (Canada)

^h NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

ⁱ INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^j WORLD HEALTH ORGANIZATION   (Switzerland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CARCINOGEN; MUTAGENIC AGENT;

ANEUPLOIDY; BACTERIUM; CELL CULTURE; DNA ADDUCT; DNA MODIFICATION; DNA STRAND BREAKAGE; ENVIRONMENTAL EXPOSURE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE MUTATION; GENOTOXICITY; GERM CELL; HUMAN; MICRONUCLEUS TEST; MUTAGEN TESTING; MUTAGENICITY; NONHUMAN; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TRANSGENIC ANIMAL; WORLD HEALTH ORGANIZATION;

ANIMALS; CARCINOGENS; DNA DAMAGE; FORECASTING; GERM CELLS; HUMANS; INTERNATIONAL COOPERATION; LEGISLATION AS TOPIC; MUTAGENICITY TESTS; MUTAGENS; RISK ASSESSMENT; WORLD HEALTH ORGANIZATION;

EID: 67650869760     PISSN: 02678357     EISSN: 14643804     Source Type: Journal    
DOI: 10.1093/mutage/gep014     Document Type: Review

References (67)

1. Ashby, J., Waters, M. D., Preston, J. et al. (1996) IPCS harmonization of methods for the prediction and quantification of human carcinogenic/ mutagenic hazard, and for indicating the probable mechanism of action of carcinogens. Mutat. Res., 352, 153-157.
2. ICH Steering Committee (1997) Guidance for Industry. S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. pp. 1-8.
3. Müller, L., Kikuchi, Y., Probst, G., Schechtman, L., Shimada, H., Sofuni, T. and Tweats, D. (1999) ICH-harmonised guidances on genotoxicity testing of pharmaceuticals: evolution, reasoning and impact. Mutat. Res., 436, 195-225.
4. United Kingdom Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (2000) Guidance on a Strategy for Testing of Chemicals for Mutagenicity. pp. 1-36. (http://www.dh.gov. uk/assetRoot/04/07/71/96/04077196.pdf) (last accessed 14 August 2008).
5. United States Food and Drug Administration (2000) Toxicological Principles for the Safety Assessment of Food Ingredients. Redbook 2000. IV.C.1. Short-Term Tests for Genetic Toxicity. Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, College Park, MD, pp. 1-5.
6. Dearfield, K. L. and Moore, M. M. (2005) Use of genetic toxicology information for risk assessment. Environ. Mol. Mutagen., 46, 236-245.
7. Cimino, M. C. (2006) Comparative overview of current international strategies and guidelines for genetic toxicology testing for regulatory purposes. Environ. Mol. Mutagen., 47, 362-390.
8. Brambilla, G. and Martelli, A. (2003) Failure of the standard battery of short-term tests in detecting some rodent and human genotoxic carcinogens. Toxicology, 196, 1-19.
9. Kirkland, D., Aardema, M., Henderson, L. and Müller, L. (2005) Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens. I. Sensitivity, specificity and relative predictivity. Mutat. Res., 584, 1-256.
10. Kirkland, D., Aardema, M., Müller, L. and Makoto, H. (2006) Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens. II. Further analysis of mammalian cell results, relative predictivity and tumour profiles. Mutat. Res., 608, 29-42.
11. Matthews, E.J., Kruhlak, N. L., Cimino, M. C., Benz, R. D. and Contrera, J. F. (2006) An analysis of genetic toxicity, reproductive and developmental toxicity, and carcinogenicity data: I. Identification of carcinogens using surrogate endpoints. Regul. Toxicol. Pharmacol., 44, 83-96.
12. Kirkland, D. J., Hayashi, M., Jacobson-Kram, D., Kasper, P., MacGregor, J. T., Müller, L. and Uno, Y. (2006) Summary of major conclusions from the 4th IWGT, San Francisco, 9-10 September, 2005. Mutat. Res., 627, 5-9.
13. Lorge, E., Thybaud, V., Aardema, M. J., Oliver, J., Wakata, A., Lorenzon, G. and Marzin, D. (2006) SFTG international collaborative study on in vitro micronucleus test. I. General conditions and overall conclusions of the study. Mutat. Res., 607, 13-36.
14. Burlinson, B., Tice, R. R., Speit, G. et al. (2007) Fourth international workgroup on genotoxicity testing: results of the in vivo comet assay workgroup. Mutat. Res., 627, 31-35.
15. Hayashi, M., MacGregor, J. T., Gatehouse, D. G. et al. (2007) In vivo erythrocyte micronucleus assay. III. Validation and regulatory acceptance of automated scoring and the use of rat peripheral blood reticulocytes, with discussion of non-hematopoietic target cells and a single dose-level limit test. Mutat. Res., 627, 10-30.
16. Thybaud, V., Aardema, M., Clements, J. et al. (2007) Strategy for genotoxicity testing: hazard identification and risk assessment in relation to in vitro testing. Mutat. Res., 627, 41-58.
17. Ames, B., McCann, J. and Yamasaki, E. (1975) Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mutat. Res., 31, 347-364.
18. Maron, D. M. and Ames, B. N. (1983) Revised methods for the Salmonella mutagenicity test. Mutat. Res., 113, 173-215.
19. Organisation for Economic Co-operation and Development (1997) Bacterial Reverse Mutation Test. OECD, Paris (Test Guideline 471).
20. Levin, D., Hollstein, M., Christman, M. F., Schwiers, E. A. and Ames, B. N. (1982) A new Salmonella tester strain (TA102) with A*T base pairs at the site of mutation detects oxidative mutagens. Proc. Natl Acad. Sci. USA, 79, 7445-7449.
21. Josephy, P. D., Gruz, P. and Nohmi, T. (1997) Recent advances in the construction of bacterial genotoxicity assays. Mutat. Res., 386, 1-23.
22. Nohmi, T. (2007) Novel DNA polymerases and novel genotoxicity assays. Genes Environ., 29, 75-88. (http://www.jstage.jst.go.jp/article/ jemsge/29/3/ 29-75/-article) (last accessed 14 August 2008).
23. Organisation for Economic Co-operation and Development (1997) In Vitro Mammalian Cell Gene Mutation Test. OECD, Paris (Test Guideline 476).
24. Moore, M., Honma, M., Clements, J. et al. (2002) Mouse lymphoma thymidine kinase gene mutation assay: follow-up International Workshop on Genotoxicity Test Procedures, New Orleans, Louisiana, April 2000. Environ. Mol. Mutagen., 40, 292-299.
25. Moore, M., Honma, M., Clements, J. et al. (2003) Mouse lymphoma thymidine kinase gene mutation assay: International Workshop on Genotoxicity Tests Workgroup report - Plymouth, UK 2002. Mutat. Res., 540, 127-140.
26. Moore, M. M., Honma, M., Clements, J. et al. (2007) Mouse lymphoma thymidine kinase gene mutation assay: meeting of the International Workshop on Genotoxicity Testing - San Francisco, 2005, recommendations for 24-h treatment. Mutat. Res., 627, 36-40.
27. Aaron, C. S., Bolcsfoldi, G., Glatt, H. R., Moore, M., Nishi, Y., Stankowski, L., Theiss, J. and Thompson, E. (1994) Mammalian cell gene mutation assays working group report. Mutat. Res., 312, 235-239.
28. Organisation for Economic Co-operation and Development (1997) Mammalian Erythrocyte Micronucleus Test. OECD, Paris (Test Guideline 474).
29. Parry, J. M. (ed.) (1996) Molecular cytogenetics. Mutat. Res., 372, 151-294.
30. Organisation for Economic Co-operation and Development (1997) In Vitro Mammalian Chromosome Aberration Test. OECD, Paris (Test Guideline 473).
31. Aardema, M. J., Albertini, S., Arni, P., Henderson, L. M., Kirsch-Volders, M., Mackay, J. M., Sarrif, A. M., Stringer, D. A. and Taalman, R. D. (1998) Aneuploidy: a report of an ECETOC task force. Mutat. Res., 410, 3-79.
32. Kirsch-Volders, M., Elhajouji, A., Cundari, E. and Van Hummelen, P. (1997) The in vitro micronucleus test: a multi-endpoint assay to detect simultaneously mitotic delay, apoptosis, chromosomal breakage, chromosome loss and non-disjunction. Mutat. Res., 392, 19-30.
33. Kirsch-Volders, M., Sofuni, T., Aardema, M. et al. (2003) Report from the in vitro micronucleus assay working group. Mutat. Res., 540, 153-163.
34. Fenech, M. (2000) The in vitro micronucleus technique. Mutat. Res., 455, 81-95.
35. Lorge, E., Lambert, C., Gervais, V., Becourt-Lhote, N., Delongeas, J. L. and Claude, N. (2007) Genetic toxicity assessment employing the best science for human safety evaluation. Part II: performances of the in vitro micronucleus test compared to the mouse lymphoma assay and the in vitro chromosome aberration assay. Toxicol. Sci., 96, 214-217.
36. Organisation for Economic Co-operation and Development (2008) OECD Guideline for the Testing of Chemicals. Draft Proposal for a New Guideline 487: In Vitro Mammalian Cell Micronucleus Test (MNvit). OECD, Paris, pp. 1-28.
37. Tweats, D. J., Blakey, D., Heflich, R. H. et al. (2007) Report of the IWGT working group on strategies and interpretation of regulatory in vivo tests. I. Increases in micronucleated bone marrow cells in rodents that do not indicate genotoxic hazards. Mutat. Res., 627, 78-91.
38. Tweats, D. J., Blakey, D., Heflich, R. H. et al. (2007) Report of the IWGT working group on strategy/interpretation for regulatory in vivo tests. II. Identification of in vivo-only positive compounds in the bone marrow micronucleus test. Mutat. Res., 627, 92-105.
39. Organisation for Economic Co-operation and Development (1997) Mammalian Bone Marrow Chromosome Aberration Test. OECD, Paris (Test Guideline 475).
40. Heddle, J. A., Dean, S., Nohmi, T. et al. (2000) In vivo transgenic mutation assays. Environ. Mol. Mutagen., 35, 253-259.
41. Thybaud, V., Dean, S., Nohmi, T. et al. (2003) In vivo transgenic mutation assays. Mutat. Res., 540, 141-151.
42. Lambert, I. B., Singer, T. M., Boucher, S. E. and Douglas, G. R. (2005) Detailed review of transgenic rodent mutation assays. Mutat. Res., 590, 1-280.
43. Nohmi, T. and Masumura, K. (2005) Molecular nature of intrachromoso-mal deletions and base substitutions induced by environmental mutagens. Environ. Mol. Mutagen., 45, 150-161.
44. International Programme on Chemical Safety (2006) Transgenic Animal Mutagenicity Assays. World Health Organization, Geneva (Environmental Health Criteria 233).
45. Phillips, D., Farmer, P. B., Beland, F. A., Nath, R. G., Poirier, M. C., Reddy, M. V. and Turteltaub, K. W. (2000) Methods of DNA adduct determination and their application to testing compounds for genotoxicity. Environ. Mol. Mutagen., 35, 222-233.
46. Tice, R. R., Agurell, E., Anderson, D. et al. (2000) Single cell gel/comet assay: guidelines for in vitro and in vivo genetic toxicology testing. Environ. Mol. Mutagen., 35, 206-221.
47. Hartmann, A., Agurell, E., Beevers, C. et al. (2003) Recommendations for conducting the in vivo alkaline comet assay. 4th International Comet Assay Workshop. Mutagenesis, 18, 45-51.
48. Speit, G. and Hartmann, A. (2005) The comet assay: a sensitive genotoxicity test for the detection of DNA damage. Methods Mol. Biol., 291, 85-95.
49. Smith, C. C., Adkins, D. J., Martin, E. A. and O'Donovan, M. R. (2008) Recommendations for design of the rat comet assay. Mutagenesis, 23, 233-240.
50. Madle, S., Dean, S. W., Andrae, U. et al. (1994) Recommendations for the performance of UDS tests in vitro and in vivo. Mutat. Res., 312, 263-285.
51. Organisation for Economic Co-operation and Development (1997) Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells In Vivo. OECD, Paris (Test Guideline 486).
52. Dubrova, Y. E., Plumb, M., Brown, J., Fennelly, J., Bois, P., Goodhead, D. and Jeffreys, A. J. (1998) Stage specificity, dose response, and doubling dose for mouse minisatellite germ-line mutation induced by acute radiation. Proc. Natl Acad. Sci. USA, 95, 6251-6255.
53. Yauk, C. L. (2004) Advances in the application of germline tandem repeat instability for in situ monitoring. Mutat. Res., 566, 169-182.
54. Singer, T. M., Lambert, I. B., Williams, A., Douglas, G. R. and Yauk, C. L. (2006) Detection of induced male germline mutation: correlations and comparisons between traditional germline mutation assays, transgenic rodent assays and expanded simple tandem repeat instability assays. Mutat. Res., 598, 164-193.
55. Gomes-Pereira, M. and Monckton, D. G. (2006) Chemical modifiers of unstable expanded simple tandem repeats: what goes up, must come down. Mutat. Res., 598, 15-34.
56. Adler, I. D. (1986) Clastogenic potential in mouse spermatogonia of chemical mutagens related to their cell-cycle specifications. In Ramel, C., Lambert, B. and Magnusson, J. (eds), Genetic Toxicology of Environmental Chemicals, Part B: Genetic Effects and Applied Mutagenesis. Liss, New York, pp. 477-484.
57. Wyrobek, A. J. and Adler, I. D. (1996) Detection of aneuploidy in human and rodent sperm using FISH and applications of sperm assays of genetic damage in heritable risk evaluation. Mutat. Res., 352, 173-179.
58. Hill, F. S., Marchetti, F., Liechty, M., Bishop, J., Hozier, J. and Wyrobek, A. J. (2003) A new FISH assay to simultaneously detect structural and numerical chromosomal abnormalities in mouse sperm. Mol. Reprod. Dev., 66, 172-180.
59. Haines, G. A., Hendry, J. H., Daniel, C. P. and Morris, I. D. (2002) Germ cell and dose-dependent DNA damage measured by the comet assay in murine spermatozoa after testicular X-irradiation. Biol. Reprod., 67, 854-861.
60. Horak, S., Polanska, J. and Widlak, P. (2003) Bulky DNA adducts in human sperm: relationship with fertility, semen quality, smoking, and environmental factors. Mutat. Res., 537, 53-65.
61. Ehling, U. H., Machemer, L., Buselmaier, W. et al. (1978) Standard protocol for the dominant lethal test on male mice set up by the work group "Dominant Lethal Mutations of the ad hoc Committee Chemogenetics". Arch. Toxicol., 39, 173-185.
62. Russell, L. B., Selby, P. B., von Halle, E., Sheridan, W. and Valcovic, L. (1981) The mouse specific locus test with agents other than radiations: interpretation of data and recommendations for future work. Mutat. Res., 86, 329-354.
63. Lewis, S. E., Barnett, L. B., Felton, C., Johnson, F. M., Skow, L. C., Cacheiro, N. and Shelby, M. D. (1986) Dominant visible and electro-phoretically expressed mutations induced in male mice exposed to ethylene oxide by inhalation. Environ. Mutagen., 8, 867-872.
64. Léonard, A. and Adler, I. D. (1984) Test for heritable translocations in male mammals. In Kilbey, B. J., Legator, M., Nichols, W. and Ramel, C. (eds), Handbook on Mutagenicity Test Procedures. 2nd edn. Elsevier Biomedical Press, Amsterdam, pp. 485-494.
65. Organisation for Economic Co-operation and Development (1997) Mammalian Spermatogonial Chromosome Aberration Test. OECD, Paris (Test Guideline 483).
66. Organisation for Economic Co-operation and Development (1984) Genetic Toxicology: Rodent Dominant Lethal Test. OECD, Paris (Test Guideline 478).
67. Organisation for Economic Co-operation and Development (1986) Genetic Toxicology: Mouse Heritable Translocation Assay. OECD, Paris (Test Guideline 485).