Combination comet/micronucleus assay validation performed by BioReliance under the JaCVAM initiative

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 786-788, Issue , 2015, Pages 87-97

  Pant, Kamala ^a   Krsmanovic, Ljubica ^b   Bruce, Shannon Wilson ^a   Kelley, Tawney ^a   Arevalo, Mirna ^a   Atta Safoh, Samuel ^a   Debelie, Fekadu ^a   La Force, Michelle L Klug ^a   Springer, Sandra ^a   Sly, Jamie ^a   Paranjpe, Madhav ^a   Lawlor, Timothy ^a   Aardema, Marilyn ^a,c  

^a BioReliance by SAFC   (United States)

^b Retired from BioReliance by SAFC ^*  (United States)

^c Marilyn Aardema Consulting LLC   (United States)

Author keywords

1,3 Dichloropropene; Busulfan; Combination comet MN assay; Ethionamide; In vivo comet assay; In vivo micronucleus (MN) assay; JaCVAM validation study

Indexed keywords

1,3 DICHLOROPROPENE; BUSULFAN; ETHIONAMIDE; PROPYLENE; UNCLASSIFIED DRUG; 1,3-DICHLORO-1-PROPENE; ALLYL COMPOUND;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BONE MARROW; COMET ASSAY; COMPARATIVE STUDY; CONTROLLED STUDY; DNA DAMAGE; ELECTROPHORESIS; HISTOPATHOLOGY; LIVER CELL; MALE; MAXIMUM TOLERATED DOSE; MICRONUCLEUS TEST; NONHUMAN; PRIORITY JOURNAL; RAT; STOMACH; VALIDATION STUDY; ANIMAL; DOSE RESPONSE; DRUG EFFECTS; LIVER; ORAL DRUG ADMINISTRATION; PROCEDURES; REPRODUCIBILITY; SPRAGUE DAWLEY RAT;

RATTUS;

ADMINISTRATION, ORAL; ALLYL COMPOUNDS; ANIMALS; BONE MARROW; BUSULFAN; COMET ASSAY; DNA DAMAGE; DOSE-RESPONSE RELATIONSHIP, DRUG; ETHIONAMIDE; HEPATOCYTES; LIVER; MALE; MICRONUCLEUS TESTS; RATS; RATS, SPRAGUE-DAWLEY; REPRODUCIBILITY OF RESULTS; STOMACH;

EID: 84937969456     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2015.03.010     Document Type: Article

References (16)

1. ICH harmonized tripartite guideline, Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use S2(R1) step 4 version (2011).
2. Tice E., Agurell D., Anderson B., Burlinson A., Hartmann H., Kobayashi Y., Miyamae E., Rojas J.-C., Ryu Y.F. Single cell gel/Comet assay: guidelines for in vitro and in vivo genetic toxicology testing. Environ. Mol. Mutagen. 2000, 35:206-221.
3. Hartmann A., Agurell E., Beevers C., Brendler-Schwaab S., Burlinson B., Clay P., Collins A., Smith A., Speit G., Thybaud V., Tice R.R. Recommendation for conducting the in vivo alkaline comet assay. Mutagenesis 2003, 18:45-51.
4. Burlinson B., Tice R.R., Speit G., Agurell E., Brendler-Schwaab S.Y., Collins A.R., Escobar P., Honma M., Kumaravel T.S., Nakajima M., Sasaki Y.F., Thybaud V., Uno Y., Vasquez M., Hartmann A. Fourth international workgroup on genotoxicity testing: result of the in vivo comet assay workgroup. Mutat. Res. 2007, 627:31-35.
5. G, Speit H., Kojima B., Burlinson A., Collins P., Kasper U., Plappert Y., Uno M., Vasquez C., Beevers, De Boeck P., Escobar S., Kitamoto K., Pant S., Pfuhler J., Tanaka D.D. Critical issues with the in vivo comet assay: a report of the comet assay working group in the 6th International Workshop on Genotoxicity Testing (IWGT). Mutat. Res. 2014, (available on line).
6. 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.
7. Uno Y.H., Kojima T., Omori R., Corvi M., Honma L.M., Schechtman R.R., Tice C., Beevers, De Boeck B., Burlinson C.A., Hobbs S., Kitamoto A.R., Kraynak J., McNamee Y., Nakagawa K., Plappert-Helbig C., Priestley H., Takasawa K., Wada U., Wirnitzer N., Asano P., Escobar D., Lovell T., Morita M., Nakajima Y., Hayashi M. JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: II. Summary of definitive validation study results. Mutat. Res. 2015, 786-788:45-76.
8. The Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington D.C., 1996).
9. Olive P., Banath J., Durand R. Heterogeneity in radiation-induced DNA damage and repair in tumor and normal cell using the comet assay. Radiat. Res. 1990, 122(1):86-94.
10. Collins A. The comet assay for DNA damage and repair; principles, applications, and limitations. Mol. Biotechnol. 2004, 26:249-261.
11. Heddle J. A rapid in vivo test for chromosomal damage. Mutat. Res. 1973, 18:187-190.
12. Heddle J., Hite M., Kirkhart B., Mavournin K., MacGregor J.T., Newell G.W., Salamone M. The induction of micronuclei as a measure of genotoxicity. A report of the U.S. Environmental Protection Agency gene-tox program. Mutat. Res. 1983, 123:61-118.
13. Hayashi R.R., Tice J.T., MacGregor D., Anderson D.H., Kirsch-Volders M., Oleson F.B., Pacchierotti F., Romagna H., Sutou S., Vannier B. In vivo rodent erythrocyte micronucleus assay. Mutat. Res. 1994, 312:293-304.
14. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human use. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. S2A document recommended for adoption at step 4 of the ICH process on July 19, 1995. Federal Register 61: 18198-18202, April 24, 1996.
15. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals. S2B document recommended for adoption at step 4 of the ICH process on July 16, 1997. Federal Register 62: 16026-16030, November 21, 1997.
16. Kastenbaum M.A., Bowman K.O. Tables for determining the statistical significance of mutation frequencies. Mutat. Res. 1970, 9:527-549.