Effect of reducing the top concentration used in the in vitro chromosomal aberration test in CHL cells on the evaluation of industrial chemical genotoxicity

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 741, Issue 1-2, 2012, Pages 32-56

  Morita, Takeshi ^a   Honma, Masamitsu ^a   Morikawa, Kaoru ^a  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

Author keywords

In vitro tests, Chromosomal aberration test, CHL cells, Test concentration limit, Industrial chemicals

Indexed keywords

(METHACRYLOYLOXYETHYL)TRIMETHYLAMMONIUM CHLORIDE; 1 NAPHTHYLACETIC ACID; 1,2 DICHLOROBENZENE; 1,3 BIS(2 METHYLPHENYL)GUANIDINE; 1,3,5 TRIS(3,5 DITERT BUTYL 4 HYDROXYBENZYL)ISOCYANURIC ACID; 1,4 DIBROMOBENZENE; 2 (DI N BUTYLAMINO)ETHANOL; 2 (DIETHYLAMINO)ETHYLMETHACRYLATE; 2 AMINO 5 CHLORO 4 METHYLBENZENESULFONIC ACID; 2 AMINO 5 METHYLBENZENESULFONIC ACID; 2 CHLOROPHENOL; 2 ETHYLBUTYRIC ACID; 2 HYDROXYETHYL METHACRYLATE; 2 HYDROXYPROPANENITRILE; 2,4 DINITROPHENOL; 3 AMINOBENZENESULFONIC ACID; 4 HYDROXYBENZOIC ACID; 4 METHYLBENZOIC ACID; 4,4' SULFONYLDIPHENOL; ACETOACETIC ACID METHYL ESTER; ADIPIC ACID DIBUTYL ESTER; BENZYLDIMETHYLAMINE; DICYCLOHEXYLAMINE DERIVATIVE; ETHENYLTRIMETHOXYSILANE; ETHYLANILINE; INDUSTRIAL CHEMICAL; METHACRYLIC ACID TERT BUTYL ESTER; PHTHALONITRILE; TRIACETIN; TRIPHOSPHORIC ACID; UNCLASSIFIED DRUG;

ANIMAL CELL; ARTICLE; CARCINOGENICITY; CHROMOSOME ABERRATION; GENOTOXICITY; HEALTH HAZARD; IN VITRO STUDY; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT;

ANIMALS; CELL LINE; CHEMICAL INDUSTRY; CHROMOSOME ABERRATIONS; CRICETINAE; CRICETULUS; DNA DAMAGE; JAPAN; MUTAGENICITY TESTS; MUTAGENS; RISK ASSESSMENT;

MAMMALIA;

EID: 83955165422     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2011.10.005     Document Type: Article

References (84)

1. 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., Müller 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.
2. Elespuru R.K., Agarwal R., Atrakchi A.H., Bigger C.A.H., Heflic R.H., Jagannath D.R., Levy D.D., Moore M.M., Ouyang Y., Robinson T.W., Sotomayor R.E., Cimino M.M., Dearfield K.L. Current and future application of genetic toxicology assays: the role and value of in vitro mammalian assays. Toxicol. Sci. 2009, 109:172-179.
3. Parry J.M., Parry E., Phrakonkham P., Corvi R. Analysis of published data for top concentration considerations in mammalian cell genotoxicity testing. Mutagenesis 2010, 25:531-538.
4. Kirkland D., Fowler P. Further analysis of Ames-negative rodent carcinogens that are only genotoxic in mammalian cells in vitro at concentrations exceeding 1mM, including retesting of compounds of concern. Mutagenesis 2010, 25:539-553.
5. Galloway S., Lorge E., Aardema M.J., Eastmond D., Fellows M., Heflich R., Kirkland D., Levy D.D., Lynch A.M., Marzin D., Morita T., Schuler M., Speit G. 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. 2011, 723:77-83.
6. Moore M.M., Honma M., Clements J., Awogi T., Douglas G.R., van Goethem F., Gollapudi B.B., Kimura A., Muster W., O'Donovan M., Schoeny R., Wakuri S. Suitable top concentration for tests with mammalian cells: mouse lymphoma assay workgroup. Mutat. Res. 2011, 723:84-86.
7. 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.
8. 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.
9. 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, II. Identification of genotoxicants, reprotoxicants and carcinogens using in silico methods. Regul. Toxicol. Pharmacol. 2006, 44:97-110.
10. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), S2A Guideline, Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals, Step 4 version, dated 19 July 1995. Available at (Accessed March 16, 2011). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S2_R1/Step4/S2A_step_4.pdf.
11. Organization for Economic Co-operation and Development (OECD), Guideline for the testing of chemicals, no. 473, In vitro mammalian cell chromosome aberration test, adopted May 26, 1983 (original) and July 21, 1997 (updated). Available at (Accessed March 16, 2011). http://oberon.sourceoecd.org/vl=9267407/cl=19/nw=1/rpsv/cgi-bin/fulltextew.pl%3Fprpsv=/ij/oecdjournals/1607310x/v1n4/s38/p1.idx.
12. International Conference on Harmonization, S2(R1) Guideline, Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use, step 2 version, March 6, 2008. Available at (Accessed March 16, 2011). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S2_R1/Step2/S2_R1__Guideline.pdf.
13. Ministry of Health Labor and Welfare of Japan (MHLW), Toxicity Testing Reports of Environmental Chemicals, vol. 1, 1994.
14. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 2, 1995.
15. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 3, 1996.
16. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 4, 1996.
17. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 5, 1997.
18. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 6, 1998.
19. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 7, 1999.
20. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 8 (1), 2001.
21. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 8 (2), 2001.
22. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 9, 2002.
23. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 10, 2003.
24. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 11, 2004.
25. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 12, 2005.
26. MHLW, Toxicity Testing Reports of Environmental Chemicals, vol. 13, 2006.
27. Chromosomal aberration test in cultured mammalian cells, 49 Kikyoku no. 392, Law concerning examination and regulation of manufacture, etc. of chemical substances, 1974.
28. Data Book on Chromosomal Aberration Test 1987, 19-24. LIC Co., Tokyo, (revised). M. Ishidate (Ed.).
29. Williams V.R., Naven T.R., Marchant A.C., Hirose A., Kamata E., Hayashi M. Derek for windows assessment of chromosomal aberration effects. Toxicol. Lett. 2006, 164(Suppl. (1)):S292.
30. Mekenyan O., Todorov M., Serafimova R., Stoeva S., Aptula A., Finking R., Jacob E. Identifying the structural requirements for chromosomal aberration by incorporating molecular flexibility and metabolic activation of chemicals. Chem. Res. Toxicol. 2007, 20:1927-1941.
31. Mekenyan O.G., Dimitrov S.D., Pavlov T.S., Veith G.D. A systematic approach to simulating metabolism in computational toxicology. I. The TIMES heuristic modeling framework. Curr. Pharm. Des. 2004, 10:1273-1293.
32. Mekenyan O., Dimitrov S., Dimitrova N., Dimitrova G., Pavlov T., Chankov G., Kotov S., Vasilev K., Vasilev R. Metabolic activation of chemicals; in-silico simulation. SAR QSAR Environ. Res. 2006, 17:107-120.
33. Serafimova R., Todorov M., Pavlov T., Kotov S., Jacob E., Aptula A., Mekenyan O. Identification of the structural requirements for mutagencitiy, by incorporating molecular flexibility and metabolic activation of chemicals. II. General Ames mutagenicity model. Chem. Res. Toxicol. 2007, 20:662-676.
34. OECD Screening Information Data Sets (SIDS), 2,3-Dichloronitrobenzene (3209-22-1), 1994. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/3209221.pdf.
35. OECD SIDS, Glucidyl methacrylate (106-91-2), 2000. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/106912.pdf.
36. OECD SIDS, 2,4-Dichloronitrobenzene (611-06-3), 1996. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/611063.pdf.
37. OECD SIDS, Dicyclopentadiene (77-73-6), 1998. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/77736.pdf.
38. OECD SIDS, Isocyanuric acid (108-80-5), 1999. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/108805.pdf.
39. OECD SIDS, Trimethyl phosphate (512-56-1), 1996. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/512561.pdf.
40. OECD SIDS, Glycerol triacetate (102-76-1), 2002. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/102761.pdf.
41. OECD SIDS, 1,2-Dichlorobenzene (95-50-1), 2001. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/95501.pdf.
42. OECD SIDS, 1,3-Di-o-tolylguanidine (97-39-2), 2007. Available at OECD Existing Chemicals Database, (Accessed March 16, 2011). http://webnet.oecd.org/hpv/UI/Search.aspx.
43. OECD SIDS, Dicyclohexylamine (101-83-7), 2006. Available at OECD Existing Chemicals Database, (Accessed March 16, 2011). http://webnet.oecd.org/hpv/UI/Search.aspx.
44. OECD SIDS, 2-Hydroxyethyl methacrylate (868-77-9), 2001. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/868779.pdf.
45. OECD SIDS, p-Toluic acid (99-94-5), 2008. Available at OECD Existing Chemicals Database, (Accessed March 16, 2011). http://webnet.oecd.org/hpv/UI/Search.aspx.
46. OECD SIDS, o-Phthalodinitrile (91-15-6), 2001. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/91156.pdf.
47. OECD SIDS Initial Assessment Profile, Iron salts category, 2007. Available at OECD Existing Chemicals Databse, (Accessed March 16, 2011). http://webnet.oecd.org/hpv/UI/Search.aspx.
48. OECD SIDS, Dibutyl adipate (105-99-7), 1996. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/105997.pdf.
49. OECD SIDS Initial Assessment Profile, 2-Ethylbutyric acid, 2006. Available at OECD Existing Chemicals Database, (Accessed March 16, 2011). http://webnet.oecd.org/hpv/UI/Search.aspx.
50. OECD SIDS, 2-Hydroxypropanenitrile (78-97-7), 1994. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/HYDROXYPROPANE.pdf.
51. OECD SIDS, 4-Aminotoluene-3-sulfonic acid (88-44-8), 2003. Available at (Accessed March 16, 2011 July 7, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/88448.pdf.
52. OECD SIDS, 4-Hydroxybenzoic acid (99-96-7), 1999. Available at (Accessed July 7, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/99967.pdf.
53. OECD SIDS, 2-Dimethylaminoethylmethacrylate (2867-47-2), 2002. Available at (Accessed March 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/DIMETHYLAMINO.pdf.
54. Kusakabe H., Yamakage K., Wakuri S., Sasaki K., Nakagawa Y., atanabe M., Hayashi M., Sofuni T., Ono H., Tanaka N. Relevance of chemical structure and cytotoxicity to the induction of chromosome aberrations based on the testing results of 98 high production volume industrial chemicals. Mutat. Res. 2002, 517:187-198.
55. US National Toxicology Program (NTP) Database, Available at (Accessed March 16, 2011). http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm%3Ffuseaction=salmonella.overallresults%26cas_no=111-41-1%26endpointlist=SA.
56. US NTP Database, Available at (Accessed July 7, 2011). http://ntp.niehs.nih.gov/INDEX2118.HTM.
57. US NTP Database, Available at (Accessed March 16, 2011). http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm%3Ffuseaction=salmonella.overallresults%26cas_no=95-64-7%26endpointlist=SA.
58. Morita T., Watanabe Y., Takeda K., Okumura K. Effects of pH in the in vitro chromosomal aberration test. Mutat. Res. 1989, 225:55-60.
59. Morita T., Takeda K., Okumura K. Evaluation of clastrgenicity of formic acid, acetic acid and lactic acid on cultured mammalian cells. Mutat. Res. 1990, 240:195-202.
60. Morita T., Nagaki T., Fukuda I., Okumura K. Clastogenicity of low pH to various cultured mammalian cells. Mutat. Res. 1992, 268:297-305.
61. California Environmental Protection Agency, Toxicology data review summaries, 1-Naphthaleneacetic acid, November 3, 1999. Available at (Accessed March 16, 2011). http://www.cdpr.ca.gov/docs/risk/toxsums/pdfs/423.pdf.
62. Concise International Chemical Assessment Document, No. 4, Methyl methacrylate, International Programme on Chemical Safety, WHO, 1998. Available at (Accessed July 7, 2011). http://www.who.int/ipcs/publications/cicad/en/cicad04.pdf.
63. Aardema M.J., Galloway S., Zeiger E., Cimino M.C., Hayashi M. Guidance for understanding solubility as a limiting factor for selecting the upper test concentration in the OECD in vitro micronucleus assay test guideline no. 487. Mutat. Res. 2011, 722:89-90.
64. Data Book of Chromosomal Aberration Test In Vitro 1999, Life-Science Information Center, Tokyo, (revised edition in 1998). T. Sofuni (Ed.).
65. European Food Safety Authority (EFSA) Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request related to a 17th list of substances for food contact materials. EFSA J. 2007, 601-609:1-24. Available at http://www.efsa.europa.eu/en/efsajournal/doc/afc_ej601-609_17thlist_en_op,1.pdf. (Accessed March 16, 2011).
66. Australia National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Full public report, Amino-functional alkoxysilane, File No: NA/648, 8 November 1999. Available at (Accessed March 16, 2011). http://www.nicnas.gov.au/publications/car/new/na/nafullr/na0600fr/na648fr.pdf.
67. IUCLID Dataset, European Chemical Bureau (ECB), 2-Chlorophenol, 2000. Available at (Accessed March 16, 2011). http://ecb.jrc.ec.europa.eu/iuclid-datasheet/95578.pdf.
68. HSDB, US NLM, 2-Chlorophenol, June 2009. Available at (Accessed March 16, 2011). http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB.
69. European Union (EU) Risk Assessment Report, European Commission, vol. 48, 1,4-Dichlorobenzene, 2004. Available at (Accessed March 16, 2011). http://ecb.jrc.ec.europa.eu/documents/Existing-Chemicals/RISK_ASSESSMENT/REPORT/14dichlorobenzenereport001.pdf.
70. GDCh-advisory committee on existing chemicals of environmental relevance (BUA) report 202, Monoethanolamine (2-Aminoethanol), German Chemical Society, August 1996.
71. OECD SIDS, 2-Diethylaminoethanol (100-37-8), 2002. Available at (Accessed September 16, 2011). http://www.chem.unep.ch/irptc/sids/OECDSIDS/DIETHYLAMINOETHAN.pdf.
72. Toxikologische Bewertung, Heiderberg, Berufsgenossenschaft der chemischen Industrie, vol. 68, 1997 (in German). English abstract available at TOXNET, Document Number: RISKLINE/1997090003 (Accessed March 16, 2011). http://toxnet.nlm.nih.gov/index.html.
73. 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.
74. Scott D.D., Galloway S.M., Marshall R.R., Ishidate M., Brusick D., Ashby J., Myhr B.C. Genotoxicity under extreme culture conditions. A report from ICPEMC Task Group 9. Mutat. Res. 1991, 257:147-205.
75. International Council on Mining and Metals, Health risk assessment guidance for metals, HERAG Fact sheet 05, Mutagenicity, August 2007. Available at (Accessed July 7, 2011). http://www.icmm.com/document/265.
76. Bianchini F., Caderni G., Dolara P., Tanagnelli E. Nuclear aberrations and micronuclei induction in the digestive tract of mice treated with different iron salts. J. Appl. Toxcol. 1988, 8:179-183.
77. Toxikologische Bewertung, Heiderberg, Berufsgenossenschaft der chemischen Industrie, vol. 218, 2000 (in German). English abstract available at TOXNET, Document Number: RISKLINE/2001050011 (Accessed March 16, 2011). http://toxnet.nlm.nih.gov/index.html.
78. HSDB, US NLM, N-Methylaniline, June 2005. Available at (Accessed March 16, 2011). http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB.
79. EU Risk Assessment Report, European Commission, vol. 50, Aniline, 2004. Available at (Accessed March 16, 2011). http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/anilinereport049.pdf.
80. EU, Regulation (EC) No. 1272/2008 of the European parliament and the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, Off. J. Eur. Union, L353/1, 31.12.2008.
81. Tweats D.J., Blakey D., Heflich R.H., Jacobs A., Jacobsen S.D., Morita T., Nohmi T., O'Donovan M.R., Sasaki Y.F., Sofuni T., Tice R. 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. 2007, 627:78-91.
82. Eichenbaum G., Johnson M., Kirkland D., O'Neill P., Stellar S., Bielawne J., DeWire R., Areia D., Bryant S., Weiner S., Desai-Krieger D., Guzzie-Pecka P., Evans D.C., Tonelli A. Assessment of the genotoxic and carcinogenic risks of p-nitrophenol when it is present as an impurity in a drug product. Regul. Toxicol. Pharmacol. 2009, 55:33-42.
83. Hazardous Substances Data Bank (HSDB), US National Library of Medicine (NLM), Sorbitane monostearate, June 2005. Available at (Accessed March 16, 2011). http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB.
84. Deutsche Forschungsgemeinschaft (DFG) Occupational Toxicants 1996, vol. 7. VCH Verlagsgesellschaft mbH, Weinhelm, pp. 75-89.