Evaluation of the RBC Pig-a and PIGRET assays using single doses of hydroxyurea and melphalan in rats

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 811, Issue , 2016, Pages 35-42

  Adachi, Hideki ^a   Uematsu, Yasuaki ^a   Yamada, Toru ^a  

^a DAINIPPON SUMITOMO PHARMA CO LTD   (Japan)

Author keywords

Hydroxyurea; Melphalan; PIGRET assay; Rat; RBC Pig a assay

Indexed keywords

HYDROXYUREA; MELPHALAN; MEMBRANE PROTEIN; MUTAGENIC AGENT; PHOSPHATIDYLINOSITOL GLYCAN-CLASS A PROTEIN;

ANIMAL EXPERIMENT; ARTICLE; BLOOD ANALYSIS; CONTROLLED STUDY; DOSE CALCULATION; ERYTHROCYTE; EVALUATION STUDY; GENOTOXICITY ASSAY; IN VIVO STUDY; JUGULAR VEIN; MALE; MAXIMUM TOLERATED DOSE; MONOCYTE; MUTAGENICITY; NONHUMAN; ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT; PRIORITY JOURNAL; RAT; RAT PIG-A ASSAY ON RETICULOCYTE ASSAY; RED BLOOD CELL PIG-A ASSAY; RETICULOCYTE; RETICULOCYTE COUNT; SINGLE DRUG DOSE; THROMBOCYTE COUNT; WEIGHT GAIN; ANIMAL; DRUG EFFECTS; GENETICS; MUTAGEN TESTING; PROCEDURES; SPRAGUE DAWLEY RAT;

ANIMALS; ERYTHROCYTES; HYDROXYUREA; MALE; MELPHALAN; MEMBRANE PROTEINS; MUTAGENICITY TESTS; MUTAGENS; RATS; RATS, SPRAGUE-DAWLEY; RETICULOCYTES;

EID: 84979701647     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2016.06.003     Document Type: Article

References (20)

1. [1] Kawagoe, K., Takeda, J., Endo, Y., Kinoshita, T., Molecular cloning of murine Pig-a, a gene for GPI-anchor biosynthesis, and demonstration of interspecies conservation of its structure function, and genetic locus. Genomics 23 (1994), 566–574.
2. [2] Miura, D., Dobrovolsky, M.V., Katsuura, Y., Heflich, R.H., Development of an in vivo gene mutation assay using the endogenous Pig-A gene: I. Flow cytometric detection of CD59-negative peripheral red blood cells and CD48-negative spleen T-cells from the rat. Environ. Mol. Mutagen. 49 (2008), 614–621.
3. [3] Dobrovolsky, V.N., Miura, D., Heflich, R.H., Dertinger, S.D., The in vivo Pig-a gene mutation assay, a potential tool for regulatory safety assessment. Environ. Mol. Mutagen. 51 (2010), 825–835.
4. [4] Gollapudi, B.B., Lynch, A.M., Heflich, R.H., Dertinger, S.D., Dobrovolsky, V.N., Froetschl, R., Horibata, K., Kenyon, M.O., Kimoto, T., Lovell, D.P., Stankowski, L.F. Jr., White, P.A., Witt, K.L., Tanir, J.Y., The in vivo Pig-a assay: a report of the International Workshop on Genotoxicity Testing (IWGT) workgroup. Mutat. Res. 783 (2015), 23–35.
5. [5] Kimoto, T., Chikura, S., Suzuki, K., Kobayashi, X.m., Itano, Y., Horibata, K., Honma, M., Dobrovolsky, V.N., Heflich, R.H., Miura, D., Kasahara, Y., Further development of the rat Pig-a mutation assay: measuring rat Pig-a mutant bone marrow erythroids and a high throughput assay for mutant peripheral blood reticulocytes. Environ. Mol. Mutagen. 52 (2011), 774–783.
6. [6] Kimoto, T., Horibata, K., Chikura, S., Hashimoto, K., Itoh, S., Sanada, H., Muto, S., Uno, Y., Yamada, M., Honma, M., Interlaboratory trial of the rat Pig-a mutation assay using an erythroidmarker HIS49 antibody. Mutat. Res. 755 (2013), 126–134.
7. [7] IARC, Monographs on the Evaluation of Carcinogenic Risks to Humans, Some Antiviral and Antineoplastic Drugs, and Other Pharmaceutical Agents, vol. 76, 2000, IARC, Lyon, France.
8. [8] IARC, Monographs on the evaluation of the carcinogenic risks to humans, Genetic and related effects: an updating of selected IARC monographs from Volumes 1–42, Supplement 6. 1987, IARC, Lyon, France.
9. [9] Kimoto, T., et al. The PIGRET assay, a method for measuring Pig-a gene mutation in reticulocytes, is reliable as a short-term in vivo genotoxicity test: summary of the MMS/JEMS-collaborative study across 16 laboratoriesusing 24 chemicals. Mutat. Res. 811 (2016), 3–15.
10. [10] Horibata, K., Ukai, A., Honma, M., Evaluation of rats’ in vivo genotoxicity induced by N-ethyl-N-nitrosourea in the RBC Pig-a, PIGRET, and gpt assays. Genes Environ. 36 (2014), 199–202.
11. [11] Gao, W.Y., Zhou, B.S., Johns, D.G., Mitsuya, H., Yen, Y., Role of the M2 subunit of ribonucleotide reductase in regulation by hydroxyurea of the activity of the anti-HIV-1 agent 2',3'-dideoxyinosine. Biochem. Pharmacol. 56 (1998), 105–112.
12. [12] Martus, H.J., Novak, M., Blecher, D., van Duyn-Goedhart, A., Suter, W., Gossen, J.A., van Buul, P.P., Quantitative correlation between radiation-induced mutagenesis in endogenous genes and transgenes of mouse spermatogonial stem cells. Environ. Mol. Mutagen. 34 (1999), 216–220.
13. [13] Dertinger, S.D., Phonethepswath, S., Avlasevich, S.L., Torous, D.K., Mereness, J., Bryce, S.M., Bemis, J.C., Bell, S., Weller, P., MacGregor, J.T., 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 (2012), 328–348.
14. [14] Sousa, M.M., Zub, K.A., Aas, P.A., Hanssen-Bauer, A., Demirovic, A., Sarno, A., Tian, E., Liabakk, N.B., Slupphaug, G., An inverse switch in DNA base excision and strand break repair contributes to melphalan resistance in multiple myeloma cells. PLoS One, 8, 2013, e55493.
15. [15] Shelby, M.D., Gulati, D.K., Tice, R.R., Wojciechowski, J.P., Results of tests for micronuclei and chromosomal aberrations in mouse bone marrow cells with the human carcinogens 4-aminobiphenyl treosulphan, and melphalan. Environ. Mol. Mutagen. 13 (1989), 339–342.
16. [16] Morita, T., Asano, N., Awogi, T., Sasaki, Y.F., Sato, S., Shimada, H., Sutou, S., Suzuki, T., Wakata, A., Sofuni, T., Hayashi, M., Evaluation of the rodent micronucleus assay in the screening of IARC carcinogens (groups 1, 2A and 2B). The summary report of the 6th collaborative study by CSGMT/JEMS MMS. Collaborative study of the micronucleus group test Mammalian mutagenicity study group. Mutat. Res. 389 (1997), 3–122.
17. [17] Generoso, W.M., Witt, K.L., Cain, K.T., Hughes, L., Cacheiro, N.L., Lockhart, A.M., Shelby, M.D., Dominant lethal and heritable translocation tests with chlorambucil and melphalan in male mice. Mutat. Res. 345 (1995), 167–180.
18. [18] ICH harmonized tripartite guideline, Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk M7 step 5 version (2015).
19. [19] Muto, S., Yamada, K., Kato, T., Iwase, Y., Uno, Y., Pig-a gene mutation and micronucleus induction in rat peripheral blood by methyl methanesulfonate. Genes Environ. 36 (2014), 186–190.
20. [20] Kimoto, T., Chikura, S., Suzuki-Okada, K., Kobayashi, X., Itano, Y., Miura, D., Kasahara, Y., The rat Pig-a mutation assay in single and 28 day-repeated dose study of cyclophosphamide: the PIGRET assay can detect the in vivo mutagenicity earlier than the RBC Pig-a assay. Genes Environ. 36 (2014), 191–198.