How accurate is in vitro prediction of carcinogenicity?

British Journal of Pharmacology

Volumn 162, Issue 6, 2011, Pages 1250-1258

  Walmsley, Richard Maurice ^a,b   Billinton, Nicholas ^b  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b Gentronix Ltd   (United Kingdom)

Author keywords

GADD45a; genotoxicity testing; ICH S2; safety assessment; screening

Indexed keywords

PROTEIN P53;

ACCURACY; AMES TEST; CARCINOGEN TESTING; CHEMICAL CARCINOGENESIS; CHEMOSENSITIVITY; CHROMOSOME ANALYSIS; COMPUTER ANALYSIS; COST EFFECTIVENESS ANALYSIS; DNA DAMAGE; DRUG RESEARCH; DRUG SCREENING; FLOW CYTOMETRY; GENOTOXICITY; GOOD LABORATORY PRACTICE; HAZARD ASSESSMENT; IN VITRO STUDY; MAMMAL CELL; NONHUMAN; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; REVIEW;

ANIMALS; CARCINOGENICITY TESTS; CARCINOGENS; DNA DAMAGE; DRUG DISCOVERY; DRUG EVALUATION, PRECLINICAL; FALSE POSITIVE REACTIONS; GUIDELINES AS TOPIC; MUTAGENICITY TESTS; NEOPLASMS;

EID: 79951994298     PISSN: 00071188     EISSN: 14765381     Source Type: Journal    
DOI: 10.1111/j.1476-5381.2010.01131.x     Document Type: Review

References (54)

1. Aubrecht J, Osowski JJ, Persaud P, Cheung JR, Ackerman J, Lopes SH, et al. (2007). Bioluminescent Salmonella reverse mutation assay: a screen for detecting mutagenicity with high throughput attributes. Mutagenesis 22: 335-342. (Pubitemid 47357606)
2. Avlasevich SL, Bryce SM, Cairns SE, Dertinger SD, (2006). In vitro micronucleus scoring by flow cytometry: differential staining of micronuclei versus apoptotic and necrotic chromatin enhances assay reliability. Environ Mol Mutagen 47: 56-66. (Pubitemid 43238025)
3. Billinton N, Bruce S, Hansen JR, Hastwell PW, Jagger C, McComb C, et al. (2010). A pre-validation transferability study of the GreenScreen HC GADD45a-GFP assay with a metabolic activation system (S9). Mutat Res 700: 44-50.
4. Billinton N, Hastwell PW, Beerens D, Birrell L, Ellis P, Maskell S, et al. (2008). Interlaboratory assessment of the GreenScreen HC GADD45a-GFP genotoxicity screening assay: an enabling study for independent validation as an alternative method. Mutat Res 653: 23-33.
5. Birrell L, Cahill P, Hughes C, Tate M, Walmsley RM, (2010). GADD45a-GFP GreenScreen HC assay results for the ECVAM recommended lists of genotoxic and non-genotoxic chemicals for assessment of new genotoxicity tests. Mutat Res 695: 87-95.
6. Brambilla G, Martelli A, (2009). Update on genotoxicity and carcinogenicity testing of 472 marketed pharmaceuticals. Mutat Res 681: 209-229.
7. Brendler-Schwaab S, Hartmann A, Pfuhler S, Speit G, (2005). The in vivo comet assay: use and status in genotoxicity testing. Mutagenesis 20: 245-254. (Pubitemid 41399464)
8. Brennan RJ, Schiestl RH, (2004). Detecting carcinogens with the yeast DEL assay. Methods Mol Biol 262: 111-124.
9. Bryce SM, Avlasevich SL, Bemis JC, Lukamowicz M, Elhajouji A, Van Goetham F, et al. (2008). Interlaboratory evaluation of a flow cytometric, high content in vitro micronucleus assay. Mutat Res 650: 181-195.
10. Burlinson B, Tice RR, Speit G, Agurell E, Brendler-Schwaab SY, Collins AR, et al. (2007). Fourth international workgroup on genotoxicity testing: results of the in vivo comet assay workgroup. Mutat Res 627: 31-35. (Pubitemid 46091764)
11. Collins AR, Azqueta Oscoz A, Brunborg G, Gaivão I, Giovannelli L, Kruszewski M, et al. (2008). The comet assay: topical issues. Mutagenesis 23: 143-151.
12. Cooper JA, Saracci R, Cole P, (1979). Describing the validity of carcinogen screening tests. Br J Cancer 39: 87-89. (Pubitemid 9094302)
13. Corvi R, Albertini S, Hartung T, Hoffmann S, Maurici D, Pfuhler S, et al. (2008). ECVAM retrospective validation of in vitro micronucleus test (MNT). Mutagenesis 23: 271-283. (Pubitemid 351918959)
14. Dertinger SD, Swaths P, Franklin D, Weller P, Torous DK, Bryce SM, et al. (2010). Integration of mutation and chromosomal damage endpoints into 28-day repeat dose toxicology studies. Tox Sci 115: 401-411.
15. Dertinger SD, Torous DK, Tometsko KR, (1996). Simple and reliable enumeration of micronucleated reticulocytes with a single-laser flow cytometer. Mutat Res 371: 283-292. (Pubitemid 27036291)
16. Fellows MD, O'Donovan MR, Lorge E, Kirkland D, (2008). Comparison of different methods for an accurate assessment of cytotoxicity in the in vitro micronucleus test II: practical aspects with toxic agents. Mutat Res 655: 4-21.
17. Flamand N, Marrot L, Belaidi J-P, Bourouf L, Dourille E, Feltes M, et al. (2006). Development of genotoxicity test procedures with Episkin®, a reconstructed human skin model: towards new tools for in vitro risk assessment of dermally applied compounds? Mutat Res 606: 39-51. (Pubitemid 43786411)
18. Hartmann A, Agurell E, Beevers C, Brendler-Schwaab S, Burlinson B, Clay P, et al. (2003). Recommendations for conducting the in vivo alkaline comet assay. Mutagenesis 18: 45-51. (Pubitemid 36118820)
19. Hastwell PW, Chai L-L, Roberts KJ, Webster TW, Harvey JS, Rees RW, et al. (2006). High-specificity and high-sensitivity genotoxicity assessment in a human cell line: validation of the GreenScreen HC GADD45a-GFP genotoxicity assay. Mutat Res 607: 160-175. (Pubitemid 44107783)
20. Hastwell PW, Webster TW, Tate M, Billinton N, Lynch AM, Harvey JS, et al. (2009). Analysis of 75 marketed pharmaceuticals using the GADD45a-GFP 'GreenScreen HC' genotoxicity assay. Mutagenesis 24: 455-463.
21. Hernández LG, van Steeg H, Luijtena M, van Benthem J, (2009). Mechanisms of non-genotoxic carcinogens and importance of a weight of evidence approach. Mutat Res 682: 94-109.
22. Homiski ML, Muehlbauer PA, Dobo KL, Schuler MJ, Aubrecht J, (2010). Concordance analysis of an in vitro micronucleus screening assay and the regulatory chromosome aberration assay using pharmaceutical drug candidates. Environ Mol Mutagen 51: 39-47.
23. Hontzeas N, Hafer K, Schiestl RH, (2007). Development of a microtiter plate version of the yeast DEL assay amenable to high-throughput toxicity screening of chemical libraries. Mutat Res 634: 228-234. (Pubitemid 47634001)
24. Hu T, Kaluzhny Y, Mun GC, Barnett B, Karetsky V, Wilt N, et al. (2009). Intralaboratory and interlaboratory evaluation of the EpiDerma 3D human reconstructed skin micronucleus (RSMN) assay. Mutat Res 673: 100-108.
25. International Conference on Harmonisation (2010). S2(R1) revised guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use.
26. International Conference on Harmonisation (1995). Topic S2A, Genotoxicity: guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals.
27. International Conference on Harmonisation (1997). Harmonised tripartite guideline, S2B, genotoxicity: a standard battery for genotoxicity testing of pharmaceuticals.
28. Kamber M, Fluckiger-Isler S, Engelhardt G, Jaeckh R, Zeiger E, (2009). Comparison of the Ames II and traditional Ames test responses with respect to mutagenicity, strain specificities, need for metabolism and correlation with rodent carcinogenicity. Mutagenesis 24: 359-366.
29. Kirkland D, Aardema M, Henderson L, 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. (Pubitemid 40922793)
30. Kirkland D, Fowler P, (2010). Further analysis of Ames-negative rodent carcinogens that are only genotoxic in mammalian cells in vitro at concentrations exceeding 1 mM, including retesting of compounds of concern. Mutagenesis; doi: 10.1093/mutage/geq041.
31. Kirkland D, Kasper P, Müller L, Corvi R, Speit G, (2008). Recommended lists of genotoxic and non-genotoxic chemicals for assessment of the performance of new or improved genotoxicity tests: a follow-up to an ECVAM workshop. Mutat Res 653: 99-108.
32. Kirkland D, Pfuhler S, Tweats D, Aardema M, Corvi R, Darroudi F, et al. (2007). How to reduce false positive results when undertaking in vitro genotoxicity testing and thus avoid unnecessary follow-up animal tests: report of an ECVAM Workshop. Mutat Res 628: 31-55.
33. Knight AW, Billinton N, Cahill PA, Scott A, Harvey JS, Roberts KJ, et al. (2007). An analysis of results from 305 compounds tested with the yeast RAD54-GFP genotoxicity assay (GreenScreen GC)-including relative predictivity of regulatory tests and rodent carcinogenesis and performance with autofluorescent and coloured compounds. Mutagenesis 22: 409-416. (Pubitemid 350098497)
34. Ku WW, Aubrecht J, Mauthe RJ, Schiestl RH, Fornace AJ Jr, (2007). Genetic toxicity assessment: employing the best science for human safety evaluation part VII: why not start with a single test: a transformational alternative to genotoxicity hazard and risk assessment. Toxicol Sci 99: 20-25. (Pubitemid 47250362)
35. Lane DP, (1992). P53, guardian of the genome. Nature 358: 15-16.
36. LeBarona MJ, Rasoulpoura RJ, Klapacza J, Ellis-Hutchings RG, Hollnagel HM, Gollapudi BB, (2010). Epigenetics and chemical safety assessment. Mutat Res 705: 83-95.
37. Lorge E, Hayashi M, Albertini S, Kirkland D, (2008). Comparison of different methods for an accurate assessment of cytotoxicity in the in vitro micronucleus test I. Theoretical aspects. Mutat Res 655: 1-3.
38. Lynch AM, Sasaki JC, Elespuru R, Jacobson-Kram D, Thybaud V, De Boeck M, et al. (2010). New and emerging technologies for genetic toxicity testing. Environ Mol Mutagen; doi: 10.1002/em.20614.
39. McCann J, Choi E, Yamaski E, Ames BN, (1975). Detection of carcinogens as mutagens in the Salmonella/microsome test. Part 1, assay of 300 chemicals. Proc Natl Acad Sci U S A 72: 5135-5139.
40. Mun GC, Aardema MJ, Hu T, Barnett B, Kaluzhny Y, Klausner M, et al. (2009). Further development of the EpiDerma 3D reconstructed human skin micronucleus (RSMN) assay. Mutat Res 673: 92-99.
41. Parry JM, Parry E, Phrakonkha P, Corvi R, (2010). Analysis of published data for top concentration considerations in mammalian cell genotoxicity testing. Mutagenesis; doi: 10.1093/mutage/geq046.
42. Phillips DM, (1983). Fifty years of Benzo{a]pyrene. Nature 303: 468-472.
43. Reifferscheid G, Heil J, (1996). Validation of the SOS/umu test using test results of 486 chemicals and comparison with the Ames test and carcinogenicity data. Mutat Res 369: 129-145. (Pubitemid 26279340)
44. Shaw IC, Jones HB, (1994). Mechanisms of non-genotoxic carcinogenesis. Trends Pharmacol Sci 15: 89-93. (Pubitemid 24086944)
45. Snyder RD, Ewing D, Hendry LB, (2006). DNA intercalative potential of marketed drugs testing positive in in vitro cytogenetics assays. Mutat Res 609: 47-59. (Pubitemid 44311611)
46. Snyder RD, Green JW, (2001). A review of the genotoxicity of marketed pharmaceuticals. Mutat Res 488: 151-169. (Pubitemid 32436429)
47. Tice RR, Agurell E, Anderson D, Burlinson B, Hartmann A, Kobayashi H, et al. (2000). Single cell gel/comet assay: guidelines for in vitro and in vivo genetic toxicity testing. Environ Mol Mutagen 35: 206-221. (Pubitemid 30196665)
48. Torous DK, Hall NE, Dertinger SD, Diehl MS, Illi-Love AH, Cederbrant K, et al. (2001). Flow cytometric enumeration of micronucleated reticulocytes: high transferability among 14 laboratories. Environ Mol Mutagen 38: 59-68. (Pubitemid 32762098)
49. Torous DK, Hall NE, Illi-Love AH, Diehl MS, Cederbrant K, Sandelin K, et al. (2005). Interlaboratory validation of a CD71-based flow cytometric method (MicoFlow®) for the scoring of micronucleated reticulocytes in mouse peripheral blood. Environ Mol Mutagen 45: 44-55. (Pubitemid 40209394)
50. Torous DK, Hall NE, Murante FE, Gleason SE, Tometsko CR, Dertinger SD, (2003). Comparative scoring of micronucleated reticulocytes in rat peripheral blood by flow cytometry and microscopy. Toxicol Sci 74: 309-314. (Pubitemid 36958299)
51. Tweats DJ, Blakey D, Heflich RH, Jacobs A, Jacobsen SD, Morita T, et al. (2007a). 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. (Pubitemid 46098932)
52. Tweats DJ, Blakey D, Heflich RH, Jacobs A, Jacobsen SD, Morita T, et al. (2007b). 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. (Pubitemid 46098931)
53. Westerink WMA, Stevenson JCR, Horbach GJ, Schoonen WGEJ, (2010). The development of RAD51C, Cystatin A, p53 and Nrf2 luciferase-reporter assays in metabolically competent HepG2 cells for the assessment of mechanism-based genotoxicity and of oxidative stress in the early research phase of drug development. Mutat Res 696: 21-40.
54. Yang C, Hasselgren CH, Boyer S, Arvidson K, Aveston S, Dierkes P, et al. (2008). Understanding genetic toxicity through data mining: the process of building knowledge by integrating multiple genetic toxicity databases. Toxicol Mech Methods 18: 277-295. (Pubitemid 351414968)