ECVAM prevalidation study on in vitro cell transformation assays: General outline and conclusions of the study

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 744, Issue 1, 2012, Pages 12-19

  Corvi, Raffaella ^a   Aardema, Marilyn J ^b,g   Gribaldo, Laura ^a   Hayashi, Makoto ^c,h   Hoffmann, Sebastian ^d   Schechtman, Leonard ^e,i   Vanparys, Philippe ^f,j  

^a JOINT RESEARCH CENTRE   (Italy)

^b Marilyn Aardema Consulting LLC   (United States)

^c Biosafety Research Center   (Japan)

^d Seh Consulting + Services   (Germany)

^e Innovative Toxicology Consulting LLC   (United States)

^f ALTOXICON BVBA   (Belgium)

^g PROCTER AND GAMBLE COMPANY   (United States)

^h NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

more..

Author keywords

Alternative methods; Carcinogenicity; Cell transformation assay; Regulatory toxicology; Validation

Indexed keywords

CARCINOGEN;

ANIMAL CELL; ARTICLE; CARCINOGENESIS; CELL ASSAY; CELL PH; CELL TRANSFORMATION; CELL TRANSFORMATION ASSAY; CONTROLLED STUDY; MOUSE; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REPRODUCIBILITY; STANDARDIZATION; SYRIAN HAMSTER; VALIDATION STUDY;

ANIMAL TESTING ALTERNATIVES; ANIMALS; BALB 3T3 CELLS; CARCINOGENICITY TESTS; CARCINOGENS; CELL TRANSFORMATION, NEOPLASTIC; CRICETINAE; MESOCRICETUS; MICE; REPRODUCIBILITY OF RESULTS; VALIDATION STUDIES AS TOPIC;

EID: 84859426909     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2011.11.009     Document Type: Article

References (58)

1. Sasaki K., Bohnenberger S., Hayashi K., Kunkelmann T., Muramatsu D., Phrakonkham P., Poth A., Sakai A., Salovaara S., Tanaka N., Thomas B.C., Umeda M. Recommended protocol for the BALB/c 3T3 cell transformation assay. Mutat. Res. 2012, 744:30-35.
2. Maire M.-A., Pant K., Phrakonkham P., Poth A., Schwind K.-R., Rast C., Bruce S.W., Sly J.E., Bohnenberger S., Kunkelmann T., Schulz M., Vasseur P. Recommended protocol for the Syrian hamster embryo (SHE) cell transformation assay. Mutat. Res. 2012, 744:76-81.
3. OECD, Organisation for Economic Cooperation and Development, Test guideline on carcinogenicity studies, Paris, 2009, http://titania.sourceoecd.org/vl=8769888/cl=15/nw=1/rpsv/ij/oecdjournals/1607310x/v1n4/s57/p1.
4. OECD, Organisation for Economic Cooperation and Development, Test guideline on chronic toxicity/carcinogenicity studies, Paris, 2009, http://titania.sourceoecd.org/vl=8769888/cl=15/nw=1/rpsv/ij/oecdjournals/1607310x/v1n4/s36/p1.
5. EU, 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, 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do%3Furi=CELEX%3A32006R1907%3AEN%3ANOT.
6. EU, Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, Off. J. Eur. Union L 342/59-209, 2009.
7. EU, Directive 2009/128/EC of the European Parliament and of the Council establishing a framework for Community action to achieve the sustainable use of pesticides, 2009, http://www.europarl.europa.eu/oeil/FindByProcnum.do%3Flang=en%26procnum=COD/2006/0132.
8. EU, Proposal for a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products, 2009, http://eurlex.europa.eu/LexUriServ/LexUriServ.do%3Furi=COM%3A2009%3A0267%3AFIN%3AEN%3ADOC.
9. Landolph J.R. Chemical transformation of C3H/10T1/2 Cl 8 mouse embryo cells: historical background, assessment of the transformation assay, and evolution and optimization of the transformation assay protocol. IARC Scientific Publication No. 67 1985, 185-198. IARC, Lyon, France. T. Kakunaga, H. Yamasaki (Eds.).
10. LeBoeuf R.A., Kerckaert K.A., Aardema M.J., Isfort R.J. Use of Syrian hamster embryo and BALB/c 3T3 cell transformation for assessing the carcinogenic potential of chemicals. IARC Sci. Publ. 1999, 146:409-425.
11. Adler S., Basketter D., Creton S., Pelkonen O., van Benthem J., Zuang V., Andersen K.E., Angers-Loustau A., Aptula A., Bal-Price A., Benfenati E., Bernauer U., Bessems J., Bois F.Y., Boobis A., Brandon E., Bremer S., Broschard T., Casati S., Coecke S., Corvi R., Cronin M., Daston G., Dekant W., Felter S., Grignard E., Gundert-Remy U., Heinonen T., Kimber I., Kleinjans J., Komulainen H., Kreiling R., Kreysa J., Leite S.B., Loizou G., Maxwell G., Mazzatorta P., Munn S., Pfuhler S., Phrakonkham P., Piersma A., Poth A., Prieto P., Repetto G., Rogiers V., Schoeters G., Schwarz M., Serafimova R., Tähti H., Testai E., van Delft J., van Loveren H., Vinken M., Worth A., Zaldivar J.M. Alternative (non-animal) methods for cosmetics testing: current status and future prospects-2010. Arch. Toxicol. 2011, 85:367-485.
12. Berwald Y., Sachs L. In vitro cell transformation with chemical carcinogens. Nature 1963, 200:1182-1184.
13. Berwald Y., Sachs L. In vitro transformation of normal cells to tumor cells by carcinogenic hydrocarbons. J. Natl. Cancer Inst. 1965, 35:641-661.
14. Schechtman L.M. Rodent cell transformation assays - a brief historical perspective. Mutat. Res. 2012, 744:3-7.
15. S. Creton, M. Aardema, P.L. Carmichael, J.S. Harvey, F.L. Martin, R.F. Newbold, M.R. O'Donovan, K. Pant, A. Poth, A. Sakai, K. Sasaki, A.D. Scott, L.M. Schechtman, R.R. Shen, N. Tanaka, H. Yasaei, Cell transformation assays for prediction of carcinogenic potential: state of the science and future research needs, Mutagenesis, in press, doi:10.1093/mutage/ger053.
16. OECD, Organisation for Economic Cooperation and Development, Detailed review on cell transformation assays for detection of chemical carcinogens, OECD Environment, Health and Safety Publications, Series on Testing and Assessment, No. 31, 2007, http://www.oecd.org/officialdocuments/displaydocumentpdf%3Fcote=env/jm/mono(2007)18%26doclanguage=en.
17. Combes R., Balls M., Curren R., Fischbach M., Fusenig N., Kirkland D., Lasne C., Landolph J., LeBoeuf R., Marquardt H., McCormick J., Müller L., Rivedal E., Sabbioni E., Tanaka N., Vasseur P., Yamasaki H. Cell transformation assays as predictors of human carcinogenicity - the report and recommendations of ECVAM Workshop 39. ATLA 1999, 27:745-767.
18. Vasseur P., Lasne C. OECD Detailed review paper (DRP31) on cell transformation assays for detection of chemical carcinogens: main results and conclusions. Mutat. Res. 2012, 744:8-11.
19. OECD, Organisation for Economic Cooperation and Development, Guidance document on the validation and international acceptance of the new or updated test methods for hazard assessment, OECD Environment, Health and Safety Publications, Series on Testing and Assessment, No. 34, 2005, http://appli1.oecd.org/olis/2005doc.nsf/linkto/env-jm-mono(2005)14.
20. Hartung T., Bremer S., Casati S., Coecke S., Corvi R., Fortaner S., Gribaldo L., Halder M., Hoffmann S., Roi A.J., Prieto P., Sabbioni E., Scott L., Worth A., Zuang V. A modular approach to the ECVAM principles on test validity. ATLA 2004, 32:467-472.
21. Vanparys Ph., Corvi R., Schechtman L., Aardema M., Hayashi M., Hoffmann S., Gribaldo L. ECVAM prevalidation of three cell transformation assays. ALTEX 2010, 27:267-270. (Special Issue).
22. Tanaka N., Bohnenberger S., Kunkelmann T., Munaro B., Ponti J., Poth A., Sabbioni E., Sakai A., Salovaara S., Sasaki K., Thomas B.C., Umeda M. Prevalidation study of the BALB/c 3T3 cell transformation assay for assessment of carcinogenic potential of chemicals. Mutat. Res. 2012, 744:20-29.
23. Pant K., Bruce S.W., Sly J.E., Kunkelmann T., Bohnenberger S., Poth A., Engelhardt G., Schulz M., Schwind K.-R. Prevalidation study of the Syrian hamster embryo (SHE) cell transformation assay at pH 6.7 for assessment of carcinogenic potential of chemicals. Mutat. Res. 2012, 744:54-63.
24. Maire M.-A., Pant K., Poth A., Schwind K.-R., Rast C., Bruce S.W., Sly J.E., Bohnenberger S., Kunkelmann T., Engelhardt G., Schulz M., Vasseur P. Prevalidation study of the Syrian hamster embryo (SHE) cell transformation assay at pH 7.0 for assessment of carcinogenic potential of chemicals. Mutat. Res. 2012, 744:64-75.
25. OECD, Organisation for Economic Cooperation and Development, series on principles of good laboratory practice and compliance monitoring, No 14, The Application of the Principles of GLP to in vitro Studies, November 2008, http://titania.sourceoecd.org/vl=694882/cl=12/nw=1/rpsv/cgi-bin/fulltextew.pl%3Fprpsv=/ij/oecdjournals/1607310x/v1n6/s14/p1.idx.
26. Schechtman L.M. BALB/c 3T3 cell transformation: protocols, problems and Improvements. IARC Sci. Publ. 1985, 67:165-184.
27. Kirkland D., Aardema M., Henderson L., Müller 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.
28. Custer L., Gibson D.P., Aardema M.J., LeBoeuf R.A. A refined protocol for conducting the low pH 6.7 Syrian hamster embryo (SHE) cell transformation assay. Mutat. Res. 2000, 455:129-139.
29. Hoffmann S., Hothorn L.A., Edler L., Kleensang A., Suzuki M., Phrakonkham P., Gerhard D. Statistical analysis of BALB/c 3T3 cell transformation assay data. Mutat. Res. 2012, 744:36-41.
30. Sasaki K., Tanaka N., Muramatsu D., Salovaara S., Thomas B.C., Bohnenberger S., Kunkelmann T., Poth A., Umeda M. Photo catalogue for the classification of foci in the BALB/c 3T3 cell transformation assay. Mutat. Res. 2012, 744:42-53.
31. Bohnenberger S., Kunkelmann T., Perschbcher S., Poth A., Pant K., Bruce S.W., Sly J.E., Schwind K.-R. Photo catalogue for the classification of cell colonies in the Syrian hamster embryo (SHE) cell transformation assay at pH 6.7. Mutat. Res. 2012, 744:82-96.
32. Maire M.-A., Rast C., Vasseur P. Photo catalogue for the classification of cell colonies in the Syrian hamster embryo (SHE) cell transformation assay at pH 7.0. Mutat. Res. 2012, 744:97-110.
33. Heidelberger C., Freeman A.E., Pienta R.J., Sivak A., Bertram J.S., Casto B.C., Dunkel V.C., Francis M.W., Kakunaga T., Little J.B., Schechtman L.M. Cell transformation by chemical agents - a review and analysis of the literature, a report of the U.S. Environmental Protection Agency Gene-Tox Program. Mutat. Res. 1983, 114:283-385.
34. LeBoeuf R.A., Kerckaert G.A., Aardema M.J., Gibson D.P., Brauninger R., Isfort R.J. The pH 6.7 Syrian hamster embryo cell transformation assay for assessing the carcinogenic potential of chemicals. Mutat. Res. 1996, 356:85-127.
35. NTP, NTP website at http://www.ntp-server.niehs.nih.gov/.
36. IARC Monographs on evaluation of the carcinogenic risk to man. Polynuclear aromatic compounds, part 1. Chem. Environ. Exp. Data 1983, 32:419-430.
37. Asada S., Sasaki K., Tanaka N., Takeda K., Hayashi M., Umeda M. Detection of initiating as well as promoting activity of chemicals by a novel cell transformation assay using v-Ha-ras-transfected BALB/c 3T3 cells (Bhas 42 cells). Mutat. Res. 2005, 588:7-21.
38. Oesch R., Buecker M., Glatt H.R. Activation of phenanthrene to mutagenic metabolites and evidence for at least two different activation pathways. Mutat. Res. 1981, 81:1-10.
39. Scribner J.D., Süss R. Tumor initiation and promotion. Int. Rev. Exp. Pathol. 1978, 18:137-198.
40. LeBoeuf R.A., Kerckaert G.A, Poiley J.A., Raineri R. An interlaboratory comparison of enhanced morphological transformation of Syrian hamster embryo cells cultured under conditions of reduced bicarbonate concentration and pH. Mutat. Res. 1989, 222:205-218.
41. Engelhardt G., Schwind K.-R., Muβler B. The testing of chemicals in Syrian hamster embryo (SHE) cell transformation assay for assessment of carcinogenic potential. Toxicol. In vitro 2004, 18:213-218.
42. Isfort R.J., Kerckaert G.A., LeBoeuf R.A. Comparison of the standard and reduced pH Syrian hamster embryo (SHE) cell in vitro transformation assays in predicting the carcinogenic potential of chemicals. Mutat. Res. 1996, 356:11-63.
43. OECD, Organisation for Economic Cooperation and Development, SIDS Phthalic anhydride, 2005, http://www.chem.unep.ch/irptc/sids/OECDSIDS/85449.pdf.
44. Rivedal E., Sanner T. Synergistic effect of morphological transformation of hamster embryo cells by nickel sulphate and benzo(a)pyrene. Cancer Lett. 1980, 8:203-208.
45. Sakai A., Sato M. Improvement of carcinogen identification in BALB/3T3 cell transformation by application of a 2-stage method. Mutat. Res. 1989, 214:285-296.
46. LeBoeuf R.A., Kerckaert K.A, Aardema M.J., Gibson D.P., Brauniger R., Isfort R.J. The pH 6.7 Syrian hamster cell transformation assay for assessing the carcinogenic potential of chemicals. Mutat. Res. 1996, 356:85-127.
47. Tsutsui T., Barrett C. Detection of non-mutagenic carcinogens using cultures Syrian hamster embryo cells. Alt. Anim. Test Exp. 1991, 1:65-73.
48. Holen I., Mikalsen S., Sanner T. Effects of dinitrotoluenes on morphological cell transformation and intercellular communication in Syrian hamster embryo cells. J. Toxicol. Environ. Health 1990, 29:89-98.
49. Kerckaert G.A., LeBoeuf R.A., Isford R.J. Assessing the predictiveness of Syrian hamster embryo cell transformation assay for detecting the rodent carcinogenic potential of single ring aromatic/nitroaromatic amine compounds. Toxicol. Sci. 1998, 41:189-197.
50. Dusinska M., Slamenova D., Kolman A. Use of Syrian hamster embryo (SHE) cell transformation assay for the in vitro testing of five pesticides. ATLA 1993, 21:202-205.
51. Cortesi E., Saffiotti U., Donovan P.J., Rice J.M., Kakunaga T. Dose-response studies on neoplastic transformation of BALB/3T3 clone A31-1-1 cells by aflatoxin B1, benzidine, benzo[a]pyrene, 3-methylcholanthrene, and N-methyl-N'-nitro-N-nitrosoguanidine. Teratogen. Carcinogen. Mutagen. 1983, 3:101-110.
52. Kajiwara Y., Ajimi S. Verification of the BALB/c 3T3 cell transformation assay after improvement by using an ITES-medium. Toxicol. In Vitro 2003, 17:489-496.
53. Sanner T., Rivedal E. Tests with the Syrian hamster embryo (SHE) cell transformation assay. Mutat. Res. 1985, 5:665-683.
54. Barrett J.C., Lamb P.W. Tests with the Syrian hamster embryo cell transformation assay. Mutat. Res. 1985, 5:623-628.
55. Matthews E.J., Spalding J.W., Tennant R.W. Transformation of BALB/c-3T3 cells: V. Transformation responses of 168 chemicals compared with mutagenicity in Salmonella and carcinogenicity in rodent bioassays. Environ. Health Perspect. 1993, 101(Suppl. 2):347-482.
56. Z. Elias, O. Poirot, M.C. Daniere, F. Terzetti, A.M. Marande, S. Dhalluin, G. Nguyen-Ba, Etude du test de transformation de cellules embryonnaires de hamster Syrien comme modèle de détection des cancérogènes non-génotoxiques, INRS, Etudes, et Recherches. Fiches Scientifiques et Techniques, 1996, Rapport N° B.3/1.028, 1-16.
57. Genotoxicity and Carcinogenicity Expert Database, https://www.lhasalimited.org/library/item/carcinogenicity_and_genotoxicity_experience_cgx_database/.
58. Handbook of Carcinogenicity and Genotoxicity Databases 1997, 754. CRC Press, Boca Raton (FL), USA. L.S. Gold, E. Zeiger (Eds.).