Evaluation of multi-organ DNA damage by comet assay from 28 days repeated dose oral toxicity test in mice: A practical approach for test integration in regulatory toxicity testing

Regulatory Toxicology and Pharmacology

Volumn 58, Issue 1, 2010, Pages 145-154

  Kushwaha, S ^a   Tripathi, D N ^a   Vikram, A ^a   Ramarao, P ^a   Jena, G B ^a  

^a NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

Comet assay; DNA damage; Methotrexate; Mice; Micronucleus assay; Test integration

Indexed keywords

METHOTREXATE;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BLOOD TOXICITY; BODY WEIGHT; COMET ASSAY; CONTROLLED STUDY; DNA DAMAGE; DOSE RESPONSE; DRUG ADMINISTRATION ROUTE; DRUG DOSE COMPARISON; DRUG MEGADOSE; FLUID INTAKE; FOOD INTAKE; GENOTOXICITY; HISTOPATHOLOGY; LIVER STRUCTURE; LUNG ALVEOLUS CELL; MALE; MICRONUCLEUS TEST; MOUSE; MULTIPLE ORGAN FAILURE; NONHUMAN; ORGAN WEIGHT; OXIDATIVE STRESS; PRIORITY JOURNAL; REPEATED DRUG DOSE; RETICULOCYTE; TOXICITY TESTING;

ANIMALS; BODY WEIGHT; BRAIN; COMET ASSAY; DNA DAMAGE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRINKING BEHAVIOR; FEEDING BEHAVIOR; GLUTATHIONE; HEMATOLOGIC TESTS; LIVER; MALE; MALONDIALDEHYDE; METHOTREXATE; MICE; MUTAGENS; ORGAN SIZE;

ANIMALIA; MUS;

EID: 77955922738     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2010.05.004     Document Type: Article

References (47)

1. Aggarwal P., Naik S., Mishra K.P., Aggarwal A., Misra R. Correlation between methotrexate efficacy & toxicity with C677T polymorphism of the methylenetetrahydrofolate gene in rheumatoid arthritis patients on folate supplementation. Indian J. Med. Res. 2006, 124:521-526.
2. Asanami S., Shimono K., Sawamoto O., Kurisu K., Uejima M. The suitability of rat peripheral blood in subchronic studies for the micronucleus assay. Mutat. Res. 1995, 347:73-78.
3. Belur L.R., James R.I., May C., Diers M.D., Swanson D., Gunther R., McIvor R.S. Methotrexate preconditioning allows sufficient engraftment to confer drug resistance in mice transplanted with marrow expressing drug-resistant dihydrofolate reductase activity. J. Pharmacol. Exp. Ther. 2005, 314:668-674.
4. Branda R.F., O'Neill J.P., Brooks E.M., Powden C., Naud S.J., Nicklas J.A. The effect of dietary folic acid deficiency on the cytotoxic and mutagenic responses to methyl methanesulfonate in wild-type and in 3-methyladenine DNA glycosylase-deficient Aag null mice. Mutat. Res. 2007, 615:12-17.
5. Cetin A., Kaynar L., Kocyigit I., Hacioglu S.K., Saraymen R., Ozturk A., Sari I., Sagdic O. Role of grape seed extract on methotrexate induced oxidative stress in rat liver. Am. J. Chin. Med. 2008, 36:861-872.
6. Cetinkaya A., Bulbuloglu E., Kurutas E.B., Kantarceken B. N-acetylcysteine ameliorates methotrexate-induced oxidative liver damage in rats. Med. Sci. Monit. 2006, 12:274-278.
7. Chow M., Koo J., Ng P., Rubin H. Random population-wide genetic damage induced in replicating cells treated with methotrexate. Mutat. Res. 1998, 413:251-264.
8. Fairbairn D.W., Olive P.L., O'Neill K.L. The comet assay: a comprehensive review. Mutat. Res. 1995, 339:37-59.
9. Hartmann A., Agurell E., Beevers C., Brendler-Schwaab S., Burlinson B., Clay P., Collins A., Smith A., Speit G., Thybaud V., Tice R.R. Recommendations for conducting the in vivo alkaline Comet assay: 4th International Comet Assay Workshop. Mutagenesis 2003, 18:45-51.
10. Hayashi M., MacGregor J.T., Gatehouse D.G., Adler I.D., Blakey D.H., Dertinger S.D., Krishna G., Morita T., Russo A., Sutou S. In vivo rodent erythrocyte micronucleus assay. II. Some aspects of protocol design including repeated treatments, integration with toxicity testing, and automated scoring. Environ. Mol. Mutagen. 2000, 35:234-252.
11. Hayashi M., Tice R.R., MacGregor J.T., Anderson D., Blakey D.H., Kirsh-Volders M., Oleson F.B., Pacchierotti F., Romagna F., Shimada H., et al. In vivo rodent erythrocyte micronucleus assay. Mutat. Res. 1994, 312:293-304.
12. Holden H.E., Majeska J.B., Studwell D. A direct comparison of mouse and rat bone marrow and blood as target tissues in the micronucleus assay. Mutat. Res. 1997, 391:87-89.
13. Hoffmann S., Saliner A.G., Patlewicz G., Eskes C., Zuang V., Worth A.P. A feasibility study developing an integrated testing strategy assessing skin irritation potential of chemicals. Toxicol. Lett. 2008, 180:9-20.
14. IWGT, 2009. 5th International Workshop on Genotoxicity Testing. August 17-19, Biozentrum of the University of Basel, Switzerland. Available from:http://www.pharmazentrum.unibas.ch.
15. Jena G.B., Bhunya S.P. Mutagenicity of an organophosphate insecticide acephate - an in vivo study in chicks. Mutagenesis 1994, 9:319-324.
16. Kim I.Y., Hyun C.K. Comparative evaluation of the alkaline comet assay with the micronucleus test for genotoxicity monitoring using aquatic organisms. Ecotoxicol. Environ. Saf. 2006, 64:288-297.
17. Kirkland D., Speit G. Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens III. Appropriate follow-up testing in vivo. Mutat. Res. 2008, 654:114-132.
18. Krishna G., Urda G., Theiss J. Principles and practices of integrating genotoxicity evaluation into routine toxicology studies: a pharmaceutical industry perspective. Environ. Mol. Mutagen. 1998, 32:115-120.
19. Laharie D., Terrebonne E., Vergniol J., Chanteloup E., Chabrun E., Couzigou P., de Ledinghen V. The liver and methotrexate. Gastroenterol. Clin. Biol. 2008, 32:134-142.
20. Lateef O., Shakoor N., Balk R.A. Methotrexate pulmonary toxicity. Expert Opin. Drug Saf. 2005, 4:723-730.
21. Lovell D.P., Omori T. Statistical issues in the use of the comet assay. Mutagenesis 2008, 23:171-182.
22. Lowry O.H., Rosebrough N.J., Farr A.L., Randall R.J. Protein measurement with the Folin phenol reagent. J. Biol. Chem. 1951, 193:265-275.
23. MacGregor J.T., Tucker J.D., Eastmond D.A., Wyrobek A.J. Integration of cytogenetic assays with toxicology studies. Environ. Mol. Mutagen. 1995, 25:328-337.
24. Moron M.S., Depierre J.W., Mannervik B. Levels of glutathione, glutathione reductase and glutathione S-transferase activities in rat lung and liver. Biochim. Biophys. Acta 1979, 582:67-78.
25. Ohkawa H., Ohishi N., Yagi K. Assay for lipid peroxides in animal tissues by thiobarbituric acid reaction. Anal. Biochem. 1979, 95:351-358.
26. Oshida K., Iwanaga E., Miyamoto-Kuramitsu K., Miyamoto Y. An in vivo comet assay of multiple organs (liver, kidney and bone marrow) in mice treated with methyl methanesulfonate and acetaminophen accompanied by hematology and/or blood chemistry. J. Toxicol. Sci. 2008, 33:515-524.
27. Padmanabhan S., Tripathi D.N., Vikram A., Ramarao P., Jena G.B. Cytotoxic and genotoxic effects of methotrexate in germ cells of male Swiss mice. Mutat. Res. 2008, 655:59-67.
28. Padmanabhan S., Tripathi D.N., Vikram A., Ramarao P., Jena G.B. Methotrexate-induced cytotoxicity and genotoxicity in germ cells of mice: intervention of folic and folinic acid. Mutat. Res. 2009, 673:43-52.
29. Pfuhler S., Kirkland D., Kasper P., Hayashi M., Vanparys P., Carmichael P., Dertinger S., Eastmond D., Elhajouji A., Krul C., Rothfuss A., Schoening G., Smith A., Speit G., Thomas C., van Benthem J., Corvi R. Reduction of use of animals in regulatory genotoxicity testing: Identification and implementation opportunities - report from an ECVAM workshop. Mutat. Res. 2009, 680:31-42.
30. Rajamani R., Muthuvel A., Senthilvelan M., Sheeladevi R. Oxidative stress induced by methotrexate alone and in the presence of methanol in discrete regions of the rodent brain, retina and optic nerve. Toxicol. Lett. 2006, 165:265-273.
31. Sasaki Y.F., Sekihashi K., Izumiyama F., Nishidate E., Saga A., Ishida K., Tsuda S. The comet assay with multiple mouse organs: comparison of comet assay results and carcinogenicity with 208 chemicals selected from the IARC monographs and U.S. NTP Carcinogenicity Database. Crit. Rev. Toxicol 2000, 30:629-799.
32. Sekihashi K., Sasaki T., Yamamoto A., Kawamura K., Ikka T., Tsuda S., Sasaki Y.F. A comparison of intraperitoneal and oral gavage administration in comet assay in mouse eight organs. Mutat. Res. 2001, 493:39-54.
33. Sekihashi K., Yamamoto A., Matsumura Y., Ueno S., Watanabe-Akanuma M., Kassie F., Knasmüller S., Tsuda S., Sasaki Y.F. Comparative investigation of multiple organs of mice and rats in the comet assay. Mutat. Res. 2002, 517:53-75.
34. Singh N.P., McCoy M.T., Tice R.R., Schneider E.L. A simple technique for quantitation of low levels of DNA damage in individual cells. Exp. Cell Res. 1988, 175:184-191.
35. Speit G., Hartmann A. The comet assay: a sensitive genotoxicity test for the detection of DNA damage and repair. Methods Mol. Biol. 2006, 314:275-286.
36. Speit G., Vasquez M., Hartmann A. The comet assay as an indicator test for germ cell genotoxicity. Mutat. Res. 2009, 681:3-12.
37. Tian H., Cronstein B.N. Understanding the mechanisms of action of methotrexate: implications for the treatment of rheumatoid arthritis. Bull. NYU Hosp. Jt. Dis. 2007, 65:168-173.
38. Tice R.R., Agurell E., Anderson D., Burlinson B., Hartmann A., Kobayashi H., Miyamae Y., Rojas E., Ryu J.C., Sasaki Y.F. Single cell gel/comet assay: guidelines for in vitro and in vivo genetic toxicology testing. Environ. Mol. Mutagen. 2000, 35:206-221.
39. Tripathi D.N., Jena G.B. Intervention of astaxanthin against cyclophosphamide-induced oxidative stress and DNA damage: a study in mice. Chem. Biol. Interact. 2009, 180:398-406.
40. Tripathi D.N., Pawar A.A., Vikram A., Ramarao P., Jena G.B. Use of the alkaline comet assay for the detection of transplacental genotoxins in newborn mice. Mutat. Res. 2008, 653:134-139.
41. Tsuda S., Matsusaka N., Madarame H., Miyamae Y., Ishida K., Satoh M., Sekihashi K., Sasaki Y.F. The alkaline single cell electrophoresis assay with eight mouse organs: results with 22 mono-functional alkylating agents (including 9 dialkyl N-nitrosoamines) and 10 DNA crosslinkers. Mutat. Res. 2000, 467:83-98.
42. Uzar E., Koyuncuoglu H.R., Uz E., Yilmaz H.R., Kutluhan S., Kilbas S., Gultekin F. The activities of antioxidant enzymes and the level of malondialdehyde in cerebellum of rats subjected to methotrexate: protective effect of caffeic acid phenethyl ester. Mol. Cell Biochem. 2006, 291:63-68.
43. Van der Jagt, K., Munn, S., Tørsløv, J., de Bruijn, J., 2004. 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" Report EUR 21405. European Commission, Joint Research Centre, Ispra, Italy.
44. Vasquez M.Z. Combining the in vivo comet and micronucleus assays: a practical approach to genotoxicity testing and data interpretation. Mutagenesis 2010, 25:187-199.
45. Vikram A., Tripathi D.N., Ramarao P., Jena G.B. Evaluation of streptozotocin genotoxicity in rats from different ages using the micronucleus assay. Regul. Toxicol. Pharmacol. 2007, 49:238-244.
46. Vinson R.K., Hales B.F. Expression and activity of the DNA repair enzyme uracil DNA glycosylase during organogenesis in the rat conceptus and following methotrexate exposure in vitro. Biochem. Pharmacol. 2002, 64:711-721.
47. Vrzoc M., Petras M.L. Comparison of alkaline single cell gel (Comet) and peripheral blood micronucleus assays in detecting DNA damage caused by direct and indirect acting mutagens. Mutat. Res. 1997, 381:31-40.