Applicability and robustness of the hen's egg test for analysis of micronucleus induction (HET-MN): Results from an inter-laboratory trial

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 747, Issue 1, 2012, Pages 118-134

  Greywe, Daniela ^a   Kreutz, Jürgen ^b   Banduhn, Norbert ^b   Krauledat, Matthias ^b   Scheel, Julia ^b   Schroeder, Klaus R ^b   Wolf, Thorsten ^a   Reisinger, Kerstin ^b  

^a UNIVERSITY OF OSNABRÜCK   (Germany)

^b HENKEL KGAA   (Germany)

Author keywords

Alternatives to animal testing; Genotoxicity; Hen's egg; Micronucleus test; Mutagenicity

Indexed keywords

2,4 DICHLOROPHENOL; 4 CHLOROANILINE; 7,12 DIMETHYLBENZ[A]ANTHRACENE; ACRYLAMIDE; AMARANTH; AMPICILLIN; ANEUGEN; CARBENDAZIM; CLASTOGEN 4 CHLOROANILINE; CYCLOPHOSPHAMIDE; ISOPHORONE; METHOTREXATE; MYRISTIC ACID ISOPROPYL ESTER; N NITROSO DIMETHYLAMINE; NAVELBINE; ORANGE G; UNCLASSIFIED DRUG;

ARTICLE; CARCINOGENICITY; CONTROLLED STUDY; GENOTOXICITY; HENS EGG TEST FOR ANALYSIS OF MICRONUCLEUS; LABORATORY TEST; METHODOLOGY; MICRONUCLEUS TEST; PRIORITY JOURNAL; REPRODUCIBILITY; TOXICITY TESTING;

ANIMALS; CHICKENS; EGGS; MICRONUCLEUS TESTS; MUTAGENS; REPRODUCIBILITY OF RESULTS;

ANIMALIA;

EID: 84862327409     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2012.04.012     Document Type: Article

References (78)

1. Kirkland D., Aardema M., Muller L., Makoto H. 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. 2006, 608:29-42.
2. 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.
3. EU Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, Official Journal of the European Union L 66, 26-35, 2003.
4. 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, Official Journal of the European Union L 396, 2006.
5. M.S. Van der Jagt, K. Tørsløv, J. de Brujin, Alternative approaches can reduce the use of test animals under REACH. Addendum to the report " Assessment of additional testing needs under REACH. Effects of (Q)SARs, risk based testing and voluntary industry initiatives" , Joint Research Centre, European Commission Report EUR 21405 EN, 1-31, 2004.
6. OECD Guideline for the Testing of Chemicals 474: mammalian erythrocyte micronucleus test, adopted: 21st July 1997, OECD (Organisation for Economic Co-operation and Development), 1997.
7. Fenech M. The in vitro micronucleus technique. Mutat. Res. 2000, 455:81-95.
8. Krishna G., Hayashi M. In vivo rodent micronucleus assay: protocol, conduct and data interpretation. Mutat. Res. 2000, 455:155-166.
9. OECD Guideline for the Testing of Chemicals 487: in vitro mammalian cell micronucleus test, adopted: 22 July 2010, OECD (Organisation for Economic Co-operation and Development), 2010.
10. Bentivegna C.S., Ihnat M.A., Baptiste N.S., Hamilton J.W. Developmental regulation of the 3-methylcholanthrene- and dioxin-inducible CYP1A5 gene in chick embryo liver in vivo. Toxicol. Appl. Pharmacol. 1998, 151:166-173.
11. Gilday D., Gannon M., Yutzey K., Bader D., Rifkind A.B. Molecular cloning and expression of two novel avian cytochrome P450 1A enzymes induced by 2,3,7,8-tetrachlorodibenzo-p-dioxin. J. Biol. Chem. 1996, 271:33054-33059.
12. Ignarro L.J., Shideman F.E. Catechol-O-methyl transferase and monoamine oxidase activities in the heart and liver of the embryonic and developing chick. J. Pharmacol. Exp. Ther. 1968, 159:29-37.
13. Ourlin J.C., Baader M., Fraser D., Halpert J.R., Meyer U.A. Cloning and functional expression of a first inducible avian cytochrome P450 of the CYP3A subfamily (CYP3A37). Arch. Biochem. Biophys. 2000, 373:375-384.
14. Hahn C.N., Hansen A.J., May B.K. Transcriptional regulation of the chicken CYP2H1 gene. Localization of a phenobarbital-responsive enhancer domain. J. Biol. Chem. 1991, 266:17031-17039.
15. Collett R.A., Ungkitchanukit A. Phenol sulphotransferase in developing chick embryo [proceedings]. Biochem. Soc. Trans. 1979, 7:132-134.
16. Wolf T., Niehaus-Rolf C., Banduhn N., Eschrich D., Scheel J., Luepke N.P. The hen's egg test for micronucleus induction (HET-MN): novel analyses with a series of well-characterized substances support the further evaluation of the test system. Mutat. Res. 2008, 650:150-164.
17. Wolf T., Niehaus-Rolf C., Luepke N.-P. Investigating genotoxic and hematotoxic effects of n-nitrosodimethylamine, n-nitrosodiethylamine and n-nitrosodiethanolamine in the hen's egg micronucleus test (HET-MN). Food Chem. Toxicol. 2003, 41:561-573.
18. Wolf T., Niehaus-Rolf C., Luepke N.P. Some new methodological aspects of the hen's egg test for micronucleus induction (HET-MN). Mutat. Res. 2002, 514:59-76.
19. Wolf T., Luepke N.-P. Formation of micronuclei in incubated hen's eggs as a measure of genotoxicity. Mutat. Res. 1997, 394:163-175.
20. Lucas A.M., Jamroz C. Atlas of avian hematology, agriculture monograph 25 1961, U.S. Government Printing Office, Washington, D.C.
21. Bruns G.A., Ingram V.M. The erythroid cells and haemoglobins of the chick embryo. Philos. Trans. R. Soc. Lond. B Biol. Sci. 1973, 266:225-305.
22. Jonckheere A.R. A distribution-free k-sample test against ordered alternatives. Biometrika 1954, 41:133-145.
23. Hillefors-Berglund M., Liu Y., von Euler G. Persistent, specific and dose-dependent effects of toluene exposure on dopamine D2 agonist binding in the rat caudate-putamen. Toxicology 1995, 100:185-194.
24. Maronpot R.R., Mitsumori K., Mann P., Takaoka M., Yamamoto S., Usui T., Okamiya H., Nishikawa S., Nomura T. Interlaboratory comparison of the CB6F1-Tg rasH2 rapid carcinogenicity testing model. Toxicology 2000, 146:149-159.
25. Wolf T. Evaluierung der versuchstierfreien Genotoxizitätsprüfung am angebrüteten Hühnerei (Hen's Egg Test for Micronuclei-Induction, HET-MN) 2003, Tectum Verlag, Osnabrück, pp. 1-418.
26. Kirkland D.J., Aardema M., Banduhn N., Carmichael P., Fautz R., Meunier J.R., Pfuhler S. In vitro approaches to develop weight of evidence (WoE) and mode of action (MoA) discussions with positive in vitro genotoxicity results. Mutagenesis 2007, 22:161-175.
27. Pharmaceutical drugs: The views and expert opinions of an IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, which met in Lyon 1990, IARC Working Group on the evaluation of the carcinogenic risks to humans, International Agency for Research on Cancer, Lyon.
28. Luo Y., Wang X.R., Shi H.H., Mao D.Q., Sui Y.X., Ji L.L. Electron paramagnetic resonance investigation of in vivo free radical formation and oxidative stress induced by 2,4-dichlorophenol in the freshwater fish Carassius auratus. Environ. Toxicol. Chem. 2005, 24:2145-2153.
29. NTP Toxicology and Carcinogenesis Studies of 2,4-Dichlorophenol (CAS No. 120-83-2) in F344/N Rats and B6C3F1 Mice (Feed Studies), NTP National Toxicology Program, 1989.
30. H. Greim, D. Henschler, Gesundheitsschädliche Arbeitsstoffe: toxikologisch-arbeitsmedizinische Begründungen von MAK-Werten (maximale Arbeitsplatz-Konzentrationen) Deutsche Forschungsgemeinschaft [German Research Foundation] VCH-Verlagsgesellschaft (supplementary series), 2000.
31. McCarroll N.E., Protzel A., Ioannou Y., Frank Stack H.F., Jackson M.A., Waters M.D., 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. 2002, 512:1-35.
32. Aardema M.J., Albertini S., Arni P., Henderson L.M., Kirsch-Volders M., Mackay J.M., Sarrif A.M., Stringer D.A., Taalman R.D. Aneuploidy: a report of an ECETOC task force. Mutat. Res. 1998, 410:3-79.
33. Sarrif A.M., Bentley K.S., Fu L.J., O'Neil R.M., Reynolds V.L., Stahl R.G. Evaluation of benomyl and carbendazim in the in vivo aneuploidy/micronucleus assay in BDF1 mouse bone marrow. Mutat. Res. 1994, 310:143-149.
34. NTP (National Toxicology Program) toxicology and carconigenesis study of para-chloroaniline hydrochloride (Cas No. 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies), National Toxicology Program, 1989.
35. NTP Comparative toxicity studies of o-, m-, and p-chloroaniline in B6C3F1 mice, NTP National Toxicology Program, 79, 1998.
36. Sasaki Y.F., Fujikawa K., Ishida K., Kawamura N., Nishikawa Y., Ohta S., Satoh M., Madarame H., Ueno S., Susa N., Matsusaka N., Tsuda S. The alkaline single cell gel electrophoresis assay with mouse multiple organs: results with 30 aromatic amines evaluated by the IARC and U.S. NTP. Mutat. Res. 1999, 440:1-18.
37. GSK (GlaxoSmithKline) Navelbine (vinorelbine tartrate) injection, Prescribing information, 2002.
38. Mortelmans K., Haworth S., Lawlor T., Speck W., Tainer B., Zeiger E. Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals. Environ. Mutagen. 1986, 8(Suppl. 7):1-119.
39. Myhr B., McGregor D., Bowers L., Riach C., Brown A.G., Edwards I., McBride D., Martin R., Caspary W.J. L5178Y mouse lymphoma cell mutation assay results with 41 compounds. Environ. Mol. Mutagen. 1990, 16(Suppl. 18):138-167.
40. 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.
41. Anderson B.E., Zeiger E., Shelby M.D., Resnick M.A., Gulati D.K., Ivett J.L., Loveday K.S. Chromosome aberration and sister chromatid exchange test results with 42 chemicals. Environ. Mol. Mutagen. 1990, 16(Suppl. 18):55-137.
42. Stemp G., Pascoe S., Gatehouse D. In vitro and in vivo cytogenetic studies of three beta-lactam antibiotics (penicillin VK, ampicillin and carbenicillin). Mutagenesis 1989, 4:439-445.
43. NTP toxicology and carcinogenesis studies of ampicillin trihydrate (CAS No. 7177-48-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies), NTP National Toxicology Program, 1987.
44. Haworth S., Lawlor T., Mortelmans K., Speck W., Zeiger E. Salmonella mutagenicity test results for 250 chemicals. Environ. Mutagen. 1983, 5(Suppl. 1):1-142.
45. CPDB (The Carcinogenic Potency Database) The Carcinogenicity Potency Project - 2,4-Dichlorophenol (CAS 120-83-2) 2007, L. Gold (Ed.).
46. Hilliard C.A., Armstrong M.J., Bradt C.I., Hill R.B., Greenwood S.K., Galloway S.M. Chromosome aberrations in vitro related to cytotoxicity of nonmutagenic chemicals and metabolic poisons. Environ. Mol. Mutagen. 1998, 31:316-326.
47. EPA (U.S. Environmental Protection Agency) 2,4-Dichlorphenol SIDS initial assessment profile, 2002.
48. Amer S.M., Aly F.A. Genotoxic effect of 2,4-dichlorophenoxy acetic acid and its metabolite 2,4-dichlorophenol in mouse. Mutat. Res. 2001, 494:1-12.
49. IARC monographs on the evaluation of carcinogenic risks to humans polychlorophenols and their sodium salts (Group 2B), International Agency for Research on Cancer, 769, 1999.
50. McGregor D.B., Brown A., Cattanach P., Edwards I., McBride D., Riach C., Caspary W.J. Responses of the L5178Y tk+/tk- mouse lymphoma cell forward mutation assay: III. 72 coded chemicals. Environ. Mol. Mutagen. 1988, 12:85-154.
51. O'Donoghue J.L., Haworth S.R., Curren R.D., Kirby P.E., Lawlor T., Moran E.J., Phillips R.D., Putnam D.L., Rogers-Back A.M., Slesinski R.S., et al. Mutagenicity studies on ketone solvents: methyl ethyl ketone, methyl isobutyl ketone, and isophorone. Mutat. Res. 1988, 206:149-161.
52. Gulati D.K., Witt K., Anderson B., Zeiger E., Shelby M.D. Chromosome aberration and sister chromatid exchange tests in Chinese hamster ovary cells in vitro. III. Results with 27 chemicals. Environ. Mol. Mutagen. 1989, 13:133-193.
53. NTP isophorone, testing status of agents at NTP, National Toxicology Program, 2010.
54. Matsuoka A., Yamakage K., Kusakabe H., Wakuri S., Asakura M., Noguchi T., Sugiyama T., Shimada H., Nakayama S., Kasahara Y., Takahashi Y., Miura K.F., Hatanaka M., Ishidate M., Morita T., Watanabe K., Hara M., Odawara K., Tanaka N., Hayashi M., Sofuni T. Re-evaluation of chromosomal aberration induction on nine mouse lymphoma assay " unique positive" NTP carcinogens. Mutat. Res. 1996, 369:243-252.
55. NTP toxicology and carcinogenesis studies of isophorone (CAS No. 78-59-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies), NTP National Toxicology Program, 1986.
56. CPDB (The Carcinogenic Potency Database) The Carcinogenicity Potency Project - Isophorone (CAS 78-59-1) 2007, L. Gold (Ed.).
57. Pandita T.K. Assessment of the mutagenic potential of a fungicide Bavistin using multiple assays. Mutat. Res. 1988, 204:627-643.
58. Albertini S. Influence of different factors on the induction of chromosome malsegregation in Saccharomyces cerevisiae D61.M by bavistan and assessment of its genotoxic property in the Ames test and in Saccharomyces cerevisiae D7. Mutat. Res. 1989, 216:327-340.
59. IPCS Carbendazim, Environmental Health Criteria 149, International programme on chemical safety, 1993.
60. Banduhn N., Obe G. Mutagenicity of methyl 2-benzimidazolecarbamate, diethylstilbestrol and estradiol: structural chromosomal aberrations, sister-chromatid exchanges, C-mitoses, polyploidies and micronuclei. Mutat. Res. 1985, 156:199-218.
61. Tucker J.D., Auletta A., Cimino M.C., Dearfield K.L., Jacobson-Kram D., Tice R.R., Carrano A.V. Sister-chromatid exchange: second report of the Gene-Tox program. Mutat. Res. 1993, 297:101-180.
62. Elhajouji A., Tibaldi F., Kirsch-Volders M. Indication for thresholds of chromosome non-disjunction versus chromosome lagging induced by spindle inhibitors in vitro in human lymphocytes. Mutagenesis 1997, 12:133-140.
63. Seiler J.P. The mutagenicity of benzimidazole and benzimidazole derivatives. VI. Cytogenetic effects of benzimidazole derivatives in the bone marrow of the mouse and the Chinese hamster. Mutat. Res. 1976, 40:339-347.
64. Jones D.C.L., Simmon V.F., Mortelmans K.E., Mitchell A.D., Evans E.L., Jotz M.M., Riccio E.S., Robinson D.E., Kirkland B.A. In vitro and in vivo mutagenicity studies of environmental chemicals. US EPA 1984.
65. Barale R., Scapoli C., Meli C., Casini D., Minunni M., Marrazzini A., Loprieno N., Barrai I. Cytogenetic effects of benzimidazoles in mouse bone marrow. Mutat. Res. 1993, 300:15-28.
66. CPDB (The Carcinogenic Potency Database) The Carcinogenicity Potency Project - p-chloroaniline (CAS 106-47-8) 2007, L. Gold (Ed.).
67. COM (Committee on mutagenicity of chemicals in food), Draft discussion paper: genotoxicity of parachloroaniline, 2009.
68. Mitchell A.D., Rudd C.J., Caspary W.J. Evaluation of the L5178Y mouse lymphoma cell mutagenesis assay: intralaboratory results for sixty-three coded chemicals tested at SRI International. Environ. Mol. Mutagen. 1988, 12(Suppl. 13):37-101.
69. Myhr B.C., Caspary W.J. Evaluation of the L5178Y mouse lymphoma cell mutagenesis assay: intralaboratory results for sixty-three coded chemicals tested at Litton Bionetics, Inc. Environ. Mol. Mutagen. 1988, 12(Suppl. 13):103-194.
70. NTP Testing Status of Agents p-Chloroaniline, NTP National Toxicology Program, 2010.
71. Caspary W.J., Daston D.S., Myhr B.C., Mitchell A.D., Rudd C.J., Lee P.S. Evaluation of the L5178Y mouse lymphoma cell mutagenesis assay: interlaboratory reproducibility and assessment. Environ. Mol. Mutagen. 1988, 12(Suppl. 13):195-229.
72. BUA (Beratergremium für Umweltrelevante Altstoffe), p-Chloroaniline - BUA Report 153, Gesellschaft Deutscher Chemiker, Weinheim, 171, 1995.
73. Concise International Chemical Assessment Document 48 2003, IPCS 4-CHLOROANILINE, International programme on chemical safety. W.H. Organization (Ed.).
74. NTP Bioassay of p-Chloroaniline for possible Carcinogenicity (Cas No. 106-47-8), NTP National Toxicology Program, 1979.
75. IARC Monographs on the evaluation of carcinogenic risks to humans p-Chloroaniline, International Agency for Research on Cancer, 1993.
76. OEHHA No significant risk levels (NSRLS) for proposition 65 carcinogens: p-chloroaniline (CAS No. 106-47-8)and p-chloroaniline hydrochloride (CAS No. 20265-96-7), Reproductive and Cancer Hazard Assessment, Branch Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, 2010.
77. Gonzalez-Cid M., Cuello M.T., Larripa I. Comparison of the aneugenic effect of vinorelbine and vincristine in cultured human lymphocytes. Mutagenesis 1999, 14:63-66.
78. Celikler S., Bilaloglu R., Aydemir N. Genotoxic effects induced by fotemustine and vinorelbine in human lymphocytes. Z. Naturforsch. [C] 2006, 61:903-910.