Evaluation of the Pig-a, micronucleus, and comet assay endpoints in a 28-day study with ethyl methanesulfonate

Environmental and Molecular Mutagenesis

Volumn 55, Issue 6, 2014, Pages 492-499

  Gunther, William C ^a   Coffing, Stephanie L ^a   Dickinson, Donna A ^a   Engel, Maria E ^a   Fiedler, Ronald D ^b   O'Lone, Susan D ^a   Sanok, Kelley E ^a   Thiffeault, Catherine J ^b   Shutsky, Thomas J ^a   Schuler, Maik J ^a   Dobo, Krista L ^a  

^a PFIZER INC   (United States)

^b Covance Genetic Toxicology ^*  (United States)

Author keywords

In vivo genotoxicity; In vivo mutation assay; Integration

Indexed keywords

MESYLIC ACID ETHYL ESTER; MEMBRANE PROTEIN; PHOSPHATIDYLINOSITOL GLYCAN-CLASS A PROTEIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BLOOD SAMPLING; COLON; COMET ASSAY; CONTROLLED STUDY; DNA DAMAGE; ERYTHROCYTE; GENE; GENE MUTATION; GENOTOXICITY; LIVER; MALE; MICRONUCLEUS; MICRONUCLEUS TEST; MUTAGEN TESTING; NONHUMAN; PIG A ASSAY; PIG G GENE; RAT; RETICULOCYTE; ANIMAL; BIOASSAY; CYTOLOGY; DOSE RESPONSE; DRUG EFFECTS; EVALUATION STUDY; GENETICS; MUTATION RATE; PROCEDURES; SPRAGUE DAWLEY RAT; TOXICITY;

RATTUS; SUIDAE;

ANIMALS; COLON; COMET ASSAY; DNA DAMAGE; DOSE-RESPONSE RELATIONSHIP, DRUG; ENDPOINT DETERMINATION; ERYTHROCYTES; ETHYL METHANESULFONATE; LIVER; MALE; MEMBRANE PROTEINS; MICRONUCLEUS TESTS; MUTATION RATE; RATS; RATS, SPRAGUE-DAWLEY; RETICULOCYTES;

EID: 84903816591     PISSN: 08936692     EISSN: 10982280     Source Type: Journal    
DOI: 10.1002/em.21863     Document Type: Article

References (40)

1. Asanami S, Shimono K, Sawamoto O, Kurisu K, Uejima M. 1995. The suitability of rat peripheral blood in subchronic studies for the micronucleus assay. Mutat Res 347:73-78.
2. Bowen DE, Whitwell JH, Lillford L, Henderson D, Kidd D, Mc Garry S, Pearce G, Beevers C, Kirkland DJ, Work conducted at Covance Laboratories Ltd H. 2011. Evaluation of a multi-endpoint assay in rats, combining the bone-marrow micronucleus test, the Comet assay and the flow-cytometric peripheral blood micronucleus test. Mutat Res 722:7-19.
3. Bryce SM, Bemis JC, Dertinger SD. 2008. In vivo mutation assay based on the endogenous Pig-a locus. Environ Mol Mutagen 49:256-264.
4. Burlinson B, Tice RR, Speit G, Agurell E, Brendler-Schwaab SY, Collins AR, Escobar P, Honma M, Kumaravel TS, Nakajima M, Sasaki YF, Thybaud V, et al; In Vivo Comet Assay Workgroup potFIWoGT. 2007. Fourth International Workgroup on Genotoxicity testing: Results of the in vivo Comet assay workgroup. Mutat Res 627:31-35.
5. Cammerer Z, Bhalli JA, Cao X, Coffing SL, Dickinson D, Dobo KL, Dobrovolsky VN, Engel M, Fiedler RD, Gunther WC, et al. 2011. Report on stage III Pig-a mutation assays using N-ethyl-N-nitrosourea-comparison with other in vivo genotoxicity endpoints. Environ Mol Mutagen 52:721-730.
6. Cammerer Z, Elhajouji A, Suter W. 2007. In vivo micronucleus test with flow cytometry after acute and chronic exposures of rats to chemicals. Mutat Res 626(1-2):26-33.
7. Coffing S, Engel M, Dickinson D, Thiffeault C, Spellman R, Shutsky T, Schuler M. 2011. The rat gut micronucleus assay: A good choice for alternative in vivo genetic toxicology testing strategies. Environ Mol Mutagen 52:269-279.
8. Conover WJ, Iman RL. 1982. Analysis of covariance using the rank transformation. Biometrics 38:715-724.
9. Dertinger SD, Bryce SM, Phonethepswath S, Avlasevich SL. 2011. When pigs fly: Immunomagnetic separation facilitates rapid determination of Pig-a mutant frequency by flow cytometric analysis. Mutat Res 721:163-170.
10. Dertinger SD, Phonethepswath S, Avlasevich SL, Torous DK, Mereness J, Bryce SM, Bemis JC, Bell S, Weller P, Macgregor JT. 2012. Efficient monitoring of in vivo pig-a gene mutation and chromosomal damage: Summary of 7 published studies and results from 11 new reference compounds. Toxicol Sci 130:328-348.
11. Dertinger SD, Phonethepswath S, Franklin D, Weller P, Torous DK, Bryce SM, Avlasevich S, Bemis JC, Hyrien O, Palis J, MacGregor JT. 2010. Integration of mutation and chromosomal damage endpoints into 28-day repeat dose toxicology studies. Toxicol Sci 115:401-411.
12. Dobo KL, Fiedler RD, Gunther WC, Thiffeault CJ, Cammerer Z, Coffing SL, Shutsky T, Schuler M. 2011. Defining EMS and ENU dose-response relationships using the Pig-a mutation assay in rats. Mutat Res 725(1-2):13-21.
13. Fenech M. 2000. The in vitro micronucleus technique. Mutat Res 455(1-2):81-95.
14. Garriott ML, Brunny JD, Kindig DE, Parton JW, Schwier LS. 1995. The in vivo rat micronucleus test: integration with a 14-day study. Mutat Res 342(1-2):71-76.
15. Gocke E, Muller L. 2009. In vivo studies in the mouse to define a threshold for the genotoxicity of EMS and ENU. Mutat Res 678:101-107.
16. Hamada S, Sutou S, Morita T, Wakata A, Asanami S, Hosoya S, Ozawa S, Kondo K, Nakajima M, Shimada H, Osawa K, Kondo Y, Asano N, Sato S, Tamura H, Yajima N, Marshall R, Moore C, Blakey DH, Schechtman LM, Weaver JL, Torous DK, Proudlock R, Ito S, Namiki C, Hayashi M. 2001. Evaluation of the rodent micronucleus assay by a 28-day treatment protocol: Summary of the 13th Collaborative Study by the Collaborative Study Group for the Micronucleus Test (CSGMT)/Environmental Mutagen Society of Japan (JEMS)-Mammalian Mutagenicity Study Group (MMS). Environ Mol Mutagen 37:93-110.
17. Hartmann A, Agurell E, Beevers C, Brendler-Schwaab S, Burlinson B, Clay P, Collins A, Smith A, Speit G, Thybaud V, Tice RR, th International Comet Assay W. 2003. Recommendations for conducting the in vivo alkaline Comet assay. 4th International Comet Assay Workshop. Mutagenesis 18:45-51.
18. Hayashi M, MacGregor JT, Gatehouse DG, Adler ID, Blakey DH, Dertinger SD, Krishna G, Morita T, Russo A, Sutou S. 2000. 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 35:234-252.
19. Heddle JA, Dean S, Nohmi T, Boerrigter M, Casciano D, Douglas GR, Glickman BW, Gorelick NJ, Mirsalis JC, Martus HJ, Skopek TR, Thybaud V, Tindall KR, Yajima N. 2000. In vivo transgenic mutation assays. Environ Mol Mutagen 35:253-259.
20. Heddle JA, Shaver-Walker P, Tao KS, Zhang XB. 1995. Treatment protocols for transgenic mutation assays in vivo. Mutagenesis 10:467-470.
21. Henderson L, Fedyk J, Windebank S, Smith M. 1993. Induction of micronuclei in rat bone marrow and peripheral blood following acute and subchronic administration of azathioprine. Mutat Res 291:79-85.
22. ICH. 2012. International Conference on Harmonisation; guidance on S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use; availability. Notice. Fed Regist 77:33748-33749.
23. Japanese Environmental Mutagen Society-Mammalian Mutagenicity Study G, Suzuki H, Takasawa H, Kobayashi K, Terashima Y, Shimada Y, Ogawa I, Tanaka J, Imamura T, Miyazaki A, Hayashi M. 2009. Evaluation of a liver micronucleus assay with 12 chemicals using young rats (II): A study by the Collaborative Study Group for the Micronucleus Test/Japanese Environmental Mutagen Society-Mammalian Mutagenicity Study Group. Mutagenesis 24:9-16.
24. Lovell DP, Omori T. 2008. Statistical issues in the use of the comet assay. Mutagenesis 23:171-182.
25. Lynch AM, Giddings A, Custer L, Gleason C, Henwood A, Aylott M, Kenny J. 2011. International Pig-a gene mutation assay trial (stage III): Results with N-methyl-N-nitrosourea. Environ Mol Mutagen 52:699-710.
26. MacGregor JT, Wehr CM, Henika PR, Shelby MD. 1990. The in vivo erythrocyte micronucleus test: measurement at steady state increases assay efficiency and permits integration with toxicity studies. Fundam Appl Toxicol 14:513-522.
27. Miura D, Dobrovolsky VN, Kimoto T, Kasahara Y, Heflich RH. 2009. Accumulation and persistence of Pig-A mutant peripheral red blood cells following treatment of rats with single and split doses of N-ethyl-N-nitrosourea. Mutat Res 677(1-2):86-92.
28. OECD. Test No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays. OECD Publishing.
29. Phonethepswath S, Franklin D, Torous DK, Bryce SM, Bemis JC, Raja S, Avlasevich S, Weller P, Hyrien O, Palis J, Macgregor JT, Dertinger SD. 2010. Pig-a mutation: kinetics in rat erythrocytes following exposure to five prototypical mutagens. Toxicol Sci 114:59-70.
30. Recio L, Hobbs C, Caspary W, Witt KL. 2010. Dose-response assessment of four genotoxic chemicals in a combined mouse and rat micronucleus (MN) and Comet assay protocol. J Toxicol Sci 35:149-162.
31. Rothfuss A, Honma M, Czich A, Aardema MJ, Burlinson B, Galloway S, Hamada S, Kirkland D, Heflich RH, Howe J, Nakajima M, O'Donovan M, Plappert-Helbig U, Priestley C, Recio L, Schuler M, Uno Y, Martus HJ. 2011. Improvement of in vivo genotoxicity assessment: Combination of acute tests and integration into standard toxicity testing. Mutat Res 723:108-120.
32. Rothfuss A, O'Donovan M, De Boeck M, Brault D, Czich A, Custer L, Hamada S, Plappert-Helbig U, Hayashi M, Howe J, Kraynak AR, van der Leede BJ, Nakajima M, Priestley C, Thybaud V, Saigo K, Sawant S, Shi J, Storer R, Struwe M, Vock E, Galloway S. 2010. Collaborative study on fifteen compounds in the rat-liver Comet assay integrated into 2- and 4-week repeat-dose studies. Mutat Res 702:40-69.
33. Shi J, Krsmanovic L, Bruce S, Kelly T, Paranjpe M, Szabo K, Arevalo M, Atta-Safoh S, Debelie F, LaForce MK, Sly J, Springer S. 2011. Assessment of genotoxicity induced by 7, 12-dimethylbenz(a)anthracene or diethylnitrosamine in the Pig-a, micronucleus and Comet assays integrated into 28-day repeat dose studies. Environ Mol Mutagen 52:711-720.
34. Stankowski LF, Jr., Roberts DJ, Chen H, Lawlor T, McKeon M, Murli H, Thakur A, Xu Y. 2011. Integration of Pig-a, micronucleus, chromosome aberration, and Comet assay endpoints in a 28-day rodent toxicity study with 4-nitroquinoline-1-oxide. Environ Mol Mutagen 52:738-747.
35. Suzuki H, Shirotori T, Hayashi M. 2004. A liver micronucleus assay using young rats exposed to diethylnitrosamine: Methodological establishment and evaluation. Cytogenet Genome Res 104(1-4):299-303.
36. Takasawa H, Suzuki H, Ogawa I, Shimada Y, Kobayashi K, Terashima Y, Matsumoto H, Aruga C, Oshida K, Ohta R, Imamura T, Miyazaki A, Kawabata M, Minowa S, Hayashi M. 2010a. Evaluation of a liver micronucleus assay in young rats (III): A study using nine hepatotoxicants by the Collaborative Study Group for the Micronucleus Test (CSGMT)/Japanese Environmental Mutagen Society (JEMS)-Mammalian Mutagenicity Study Group (MMS). Mutat Res 698(1-2):30-37.
37. Takasawa H, Suzuki H, Ogawa I, Shimada Y, Kobayashi K, Terashima Y, Matsumoto H, Oshida K, Ohta R, Imamura T, Miyazaki A, Kawabata M, Minowa S, Maeda A, Hayashi M. 2010b. Evaluation of a liver micronucleus assay in young rats (IV): A study using a double-dosing/single-sampling method by the Collaborative Study Group for the Micronucleus Test (CSGMT)/Japanese Environmental Mutagen Society (JEMS)-Mammalian Mutagenicity Study Group (MMS). Mutat Res 698(1-2):24-29.
38. Thybaud V, Dean S, Nohmi T, de Boer J, Douglas GR, Glickman BW, Gorelick NJ, Heddle JA, Heflich RH, Lambert I, Martus HJ, Mirsalis JC, Suzuki T, Yajima N. 2003. In vivo transgenic mutation assays. Mutat Res 540:141-151.
39. Vasquez MZ. 2010. Combining the in vivo comet and micronucleus assays: A practical approach to genotoxicity testing and data interpretation. Mutagenesis 25:187-199.
40. Witt KL, Zeiger E, Tice RR, van Birgelen AP. 2000. The genetic toxicity of 3, 3′, 4, 4′-tetrachloroazobenzene and 3, 3′, 4, 4′-tetrachloroazoxybenzene: discordance between acute mouse bone marrow and subchronic mouse peripheral blood micronucleus test results. Mutat Res 472(1-2):147-154.