In vitro genotoxicity test approaches with better predictivity: Summary of an IWGT workshop

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 723, Issue 2, 2011, Pages 101-107

  Pfuhler, Stefan ^a   Fellows, Mick ^b   Van Benthem, Jan ^c   Corvi, Raffaella ^d   Curren, Rodger ^e   Dearfield, Kerry ^f   Fowler, Paul ^g   Frötschl, Roland ^h   Elhajouji, Azeddine ⁱ   Le Hégarat, Ludovic ^j   Kasamatsu, Toshio ^k   Kojima, Hajime ^l   Ouédraogo, Gladys ^m   Scott, Andrew ⁿ   Speit, Günter ^o  

^a PROCTER AND GAMBLE COMPANY   (United States)

^b ASTRAZENECA   (United Kingdom)

^c NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^d JOINT RESEARCH CENTRE   (Italy)

^e Institute for in Vitro Sciences   (United States)

^f U S DEPARTMENT OF AGRICULTURE   (United States)

^g UK   (United Kingdom)

^h BfArM   (Germany)

ⁱ NOVARTIS PHARMA AG   (Switzerland)

^j FRENCH AGENCY FOR FOOD   (France)

^k KAO CORPORATION   (Japan)

^l NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^m L ORÉAL RECHERCHE   (France)

ⁿ UNILEVER RESEARCH   (United Kingdom)

^o UNIVERSITY OF ULM   (Germany)

more..

Author keywords

In vitro genotoxicity testing; Misleading positive results; Predictive capacity; Reduction animal use

Indexed keywords

PROTEIN P53;

ANIMAL CELL; ARTICLE; CARCINOGENESIS; CELL CULTURE; CELL LINE; CELL SELECTION; FALSE POSITIVE RESULT; GENOTOXICITY; HEPATOMA CELL; HUMAN; HUMAN CELL; HUMAN CELL CULTURE; IN VITRO STUDY; MICRONUCLEUS TEST; NONHUMAN; PREDICTIVE VALUE; PRIORITY JOURNAL; PROTEIN DEFECT; TOXICITY TESTING;

ANIMALS; CELL LINE; CHROMOSOME ABERRATIONS; GUIDELINES AS TOPIC; HUMANS; MICRONUCLEUS TESTS; MUTAGENICITY TESTS; PREDICTIVE VALUE OF TESTS;

ANIMALIA; RODENTIA;

EID: 79959720615     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2011.03.013     Document Type: Article

References (29)

1. Kirkland D., Aardema M., Henderson L., Muller L. 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. 2005, 584:1-256.
2. Matthews E.J., Kruhlak N.L., Cimino M.C., Benz R.D., Contrera J.F. An analysis of genetic toxicity, reproductive and developmental toxicity, and carcinogenicity data. I. Identification of carcinogens using surrogate endpoints. Regul. Toxicol. Pharmacol. 2006, 44:83-96.
3. Pfuhler S., Kirst A., Aardema M., Banduhn N., Goebel C., Araki D., Costabel-Farkas M., Dufour E., Fautz R., Harvey J., Hewitt N.J., Hibatallah J., Carmichael P., Macfarlane M., Reisinger K., Rowland J., Schellauf F., Schepky A., Scheel J. A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Genotoxicity. A COLIPA analysis. Regul. Toxicol. Pharmacol. 2010, 57:315-324.
4. Elespuru R.K., Agarwal R., Atrakchi A.H., Bigger C.A., Heflich R.H., Jagannath D.R., Levy D.D., Moore M.M., Ouyang Y., Robison T.W., Sotomayor R.E., Cimino M.C., Dearfield K.L. Current and future application of genetic toxicity assays: the role and value of in vitro mammalian assays. Toxicol. Sci. 2009, 109:172-179.
5. Eastmond D.A., Hartwig A., Anderson D., Anwar W.A., Cimino M.C., Dobrev I., Douglas G.R., Nohmi T., Phillips D.H., Vickers C. Mutagenicity testing for chemical risk assessment: update of the WHO/IPCS Harmonized Scheme. Mutagenesis 2009, 24:341-349.
6. Dearfield K.L., Thybaud V., Cimino M.C., Custer L., Czich A., Harvey J.S., Hester S., Kim J.H., Kirkland D., Levy D.D., Lorge E., Moore M.M., Ouedraogo-Arras G., Schuler M., Suter W., Sweder K., Tarlo K., van Benthem J., van Goethem F., Witt K.L. Follow-up actions from positive results of in vitro genetic toxicity testing. Environ. Mol. Mutagen. 2011, 52:177-204.
7. Kirkland D., Pfuhler S., Tweats D., Aardema M., Corvi R., Darroudi F., Elhajouji A., Glatt H., Hastwell P., Hayashi M., Kasper P., Kirchner S., Lynch A., Marzin D., Maurici D., Meunier J.R., Muller L., Nohynek G., Parry J., Parry E., Thybaud V., Tice R., van Benthem J., Vanparys P., White P. 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. 2007, 628:31-55.
8. EC, Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACh), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX: 32006R1907:EN:NOT, 2006.
9. EC, Directive 2003/15/EC of the European Parliament and the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Members States relating to cosmetic products. Official Journal of the European Union L66, 2003, 26-35.
10. European Chemicals Agency, Guidance on information requirements and chemical safety assessment. CH. R.7a: Endpoint specific Guidance. See chapter R.7.7.1 Mutagenicity testing. P.374-402, http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_r7a_en.pdf?vers=20_08_08, 2008.
11. S. Galloway, E. Lorge, M.J. Aardema, D. Eastmond, M. Fellows, R. Heflich, D. Kirkland, D.D. Levy, A.M. Lynch, D. Marzin, T. Morita, M. Schuler, G. Speit, Workshop summary: top concentration for in vitro mammalian cell genotoxicity assays; and report from working group on toxicity measures and top concentration for in vitro cytogenetics assays (chromosome aberrations and micronucleus), Mutat. Res.: Genet. Toxicol. Environ. Mutagen. (2011), doi:10.1016/j.mrgentox.2011.01.003.
12. Kirkland D., Kasper P., Muller L., Corvi R., Speit G. 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. 2008, 653:99-108.
13. P. Fowler, K. Smith, J. Young, L. Jeffrey, D. Kirkland, S. Pfuhler, P. Carmichael, Reduction of misleading (" false" ) positive results in mammalian cell genotoxicity assays. I. Choice of cell type, Mutat. Res., submitted for publication.
14. Fellows M.D., O'Donovan M.R. Etoposide, cadmium chloride, benzo[a]pyrene, cyclophosphamide and colchicine tested in the in vitro mammalian cell micronucleus test (MNvit) in the presence and absence of cytokinesis block using L5178Y mouse lymphoma cells and 2-aminoanthracene tested in MNvit in the absence of cytokinesis block using TK6 cells at AstraZeneca UK, in support of OECD draft Test Guideline 487. Mutat. Res. 2010, 702:163-170.
15. Gripon P., Rumin S., Urban S., Le S.J., Glaise D., Cannie I., Guyomard C., Lucas J., Trepo C., Guguen-Guillouzo C. Infection of a human hepatoma cell line by hepatitis B virus. Proc. Natl. Acad. Sci. U.S.A. 2002, 99:15655-15660.
16. Cerec V., Glaise D., Garnier D., Morosan S., Turlin B., Drenou B., Gripon P., Kremsdorf D., Guguen-Guillouzo C., Corlu A. Transdifferentiation of hepatocyte-like cells from the human hepatoma HepaRG cell line through bipotent progenitor. Hepatology 2007, 45:957-967.
17. Aninat C., Piton A., Glaise D., Le C.T., Langouet S., Morel F., Guguen-Guillouzo C., Guillouzo A. Expression of cytochromes P450, conjugating enzymes and nuclear receptors in human hepatoma HepaRG cells. Drug Metab. Dispos. 2006, 34:75-83.
18. Kanebratt K.P., Andersson T.B. Evaluation of HepaRG cells as an in vitro model for human drug metabolism studies. Drug Metab. Dispos. 2008, 36:1444-1452.
19. Le Hegarat L., Dumont J., Josse R., Huet S., Lanceleur R., Mourot A., Poul J.M., Guguen-Guillouzo C., Guillouzo A., Fessard V. Assessment of the genotoxic potential of indirect chemical mutagens in HepaRG cells by the Comet and the cytokinesis-block micronucleus assays. Mutagenesis 2010, 25:555-560.
20. Dumont J., Josse R., Lambert C., Antherieu S., Le Hegarat L., Aninat C., Robin M.A., Guguen-Guillouzo C., Guillouzo A. Differential toxicity of heterocyclic aromatic amines and their mixture in metabolically competent HepaRG cells. Toxicol. Appl. Pharmacol. 2010, 245:256-263.
21. Potts R.O., Bommannan B., Guy R.H. Percutaneous absorption. Pharmacology of the Skin 1992, 12-27. CRC Press, USA. H. Mukhtar (Ed.).
22. Oesch F., Fabian E., Oesch-Bartlomowicz B., Werner C., Landsiedel R. Drug-metabolizing enzymes in the skin of man, rat, and pig. Drug Metab. Rev. 2007, 39:659-698.
23. Eilstein J., Lereaux G., Daronnat E., Dichich S., Meunier J.R., Leclair J., Duche D. Characterisation of N-acetyl transferase activity in reconstructed human skin models. Drug Metab. Rev. 2009, 41(1). Abstract68.
24. Curren R.D., Mun G.C., Gibson D.P., Aardema M.J. Development of a method for assessing micronucleus induction in a 3D human skin model (EpiDerm). Mutat. Res. 2006, 607:192-204.
25. Mun G.C., Aardema M.J., Hu T., Barnett B., Kaluzhny Y., Klausner M., Karetsky V., Dahl E.L., Curren R.D. Further development of the EpiDerm 3D reconstructed human skin micronucleus (RSMN) assay. Mutat. Res. 2009, 673:92-99.
26. Hu T., Kaluzhny Y., Mun G.C., Barnett B., Karetsky V., Wilt N., Klausner M., Curren R.D., Aardema M.J. Intralaboratory and interlaboratory evaluation of the EpiDerm 3D human reconstructed skin micronucleus (RSMN) assay. Mutat. Res. 2009, 673:100-108.
27. Aardema M.J., Barnett B.C., Khambatta Z., Reisinger K., Ouedraogo-Arras G., Faquet B., Ginestet A.C., Mun G.C., Dahl E.L., Hewitt N.J., Corvi R., Curren R.D. International prevalidation studies of the EpiDerm 3D human reconstructed skin micronucleus (RSMN) assay: transferability and reproducibility. Mutat. Res. 2010, 701:123-131.
28. Hartmann A., Plappert U., Poetter F., Suter W. Comparative study with the alkaline Comet assay and the chromosome aberration test. Mutat. Res. 2003, 536:27-38.
29. Boehme K., Dietz Y., Hewitt P., Mueller S.O. Activation of P53 in HepG2 cells as surrogate to detect mutagens and promutagens in vitro. Toxicol. Lett. 2010, 198:272-281.