Collaborative work on evaluation of ovarian toxicity by repeated-dose and fertility studies in female rats

Journal of Toxicological Sciences

Volumn 34, Issue 1, 2009, Pages

  Sanbuissho, Atsushi ^a   Yoshida, Midori ^b   Hisada, Shigeru ^c   Sagami, Fumio ^d   Kudo, Satoshi ^e   Kumazawa, Toshihiko ^f   Ube, Masayuki ^g   Komatsu, Shinichi ^h   Ohno, Yasuo ^b  

^a DAIICHI SANKYO CO   (Japan)

^b NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^c Grelan Pharmaceutical Co Ltd   (Japan)

^d EISAI CO LTD   (Japan)

^e KYORIN PHARMACEUTICAL CO LTD   (Japan)

^f SANWA KAGAKU KENKYUSHO CO LTD   (Japan)

^g MITSUBISHI TANABE PHARMA CORPORATION   (Japan)

^h Development and Medical Affairs Division   (Japan)

Author keywords

Fertility study; Ovary toxicity validation pathology

Indexed keywords

2 METHOXYETHANOL; 4 VINYLCYCLOHEXENE DIEPOXIDE; ADIPIC ACID DERIVATIVE; ALKYLATING AGENT; ANASTROZOLE; ATRAZINE; BIS(2 ETHYLHEXYL)ADIPATE; BROMOCRIPTINE; BUSULFAN; CELL NUCLEUS ANTIGEN; CHLORPROMAZINE; CISPLATIN; CYCLOHEXANE OXIDE; CYCLOPHOSPHAMIDE; HORMONE ANALOG; INDOMETACIN; MEDROXYPROGESTERONE ACETATE; MIFEPRISTONE; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR ALPHA AGONIST; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR GAMMA AGONIST; PHTHALIC ACID BIS(2 ETHYLHEXYL) ESTER; SULPIRIDE; TAMOXIFEN; UNCLASSIFIED DRUG; BIOLOGICAL MARKER; CYCLINE; XENOBIOTIC AGENT;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CELL PROLIFERATION; CONTROLLED STUDY; CYTOTOXICITY; ENDOCRINE SYSTEM; FEMALE; FEMALE FERTILITY; FEMALE GENITAL SYSTEM; HISTOPATHOLOGY; IMMUNOHISTOCHEMISTRY; METABOLITE; MORPHOLOGY; NONHUMAN; OVARY; OVARY FOLLICLE; OVARY FOLLICLE CELL; RAT; REPRODUCTIVE TOXICITY; VALIDATION STUDY; ANIMAL; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; FERTILITY; HEALTH CARE ORGANIZATION; JAPAN; METABOLISM; METHODOLOGY; OVARY DISEASE; PATHOLOGY; PATHOPHYSIOLOGY; PREGNANCY; RAT STRAIN; TOXICITY TESTING;

RATTUS;

ANIMALS; BIOLOGICAL MARKERS; FEMALE; FERTILITY; JAPAN; OVARIAN DISEASES; OVARIAN FOLLICLE; OVARY; PREGNANCY; PROLIFERATING CELL NUCLEAR ANTIGEN; PUBLIC-PRIVATE SECTOR PARTNERSHIPS; RATS; RATS, INBRED STRAINS; SOCIETIES, SCIENTIFIC; TOXICITY TESTS; XENOBIOTICS;

EID: 64949168572     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.34.s1     Document Type: Article

References (28)

1. Davis, B.J., Almekinder, J.L., Flagler, N., Travlos, G., Wilson, R. and Maronpot, R.R. (1997): Ovarian luteal cell toxicity of ethylene glycol monomethyl ether and methoxy acetic acid in vivo and in vitro. Toxicol. Appl. Pharmacol., 142, 328-37.
2. Davis, B.J., Lennard, D.E., Lee, C.A., Tiano, H.F., Morham, S.G., Wetsel, W.C. and Langenbach, R. (1999): Anovulation in cyclooxygenase-2-deficient mice is restored by prostaglandin E2 and interleukin-1beta. Endocrinology, 140, 2685-2695.
3. Dodo, T., Taketa, Y., Sugiyama, M., Inomata, A., Sonoda, J., Okuda, Y., Mineshima, H., Hosokawa, S. and Aoki, T. (2009): Collaborative work on evaluation of ovarian toxicity 11) Two-or four-week repeated-dose studies and fertility study of ethylene gly-col monomethyl ether in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP121-SP128.
4. Greenwald, G.S. and Roy, S.K. (1994): Follicular development and its control. (Eds, Knovil, E., Neil J.D.) In The Physiology of Reproduction, Second Edition, pp.629-724. Raven Press, Ltd., New York.
5. Hoyer, P.B. (2004): Ovarian toxicity in small pre-antral follicles.(Ed. Hoyer, P.B.) Ovarian Toxicology. pp.17-39, CRC Press, Boca Raton.
6. ICH (2008): ICH Harmonised Tripartite Guideline: Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals M3(R1). pp.5
7. Ishi, S., Ube, M., Okada, M., Adachi, T., Sugimoto, J., Inoue, Y.,Uno, Y. and Mutai, M. (2009): Collaborative work on evaluation of ovarian toxicity 17) Two-or four-week repeated-dose studies and fertility study of sulpiride in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP175-SP188.
8. Ito, A., Mafune, N. and Kimura, T. (2009): Collaborative work on evaluation of ovarian toxicity 4) Two-or four-week repeated dose study of 4-vinylcyclohexene diepoxide in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP53-SP58.
9. Izumi, Y., Watanabe, T., Awasaki, N., Hikawa, K., Minagi, T. and Chatani, F. (2009): Collaborative work on evaluation of ovarian toxicity 16) Effects of 2 or 4 weeks repeated dose studies and fertility study of Chlorpromazine hydrochloride in rats. J. Toxicol. Sci., 34 (Special Issue I), SP167-SP174.
10. Kodama, T., Yoshida, J., Miwa, T., Hasegawa, D. and Masuyama, T. (2009): Collaborative work on evaluation of ovarian toxicity 4) Effects of fertility study of 4-vinylcyclohexene diepoxide in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP59-SP63.
11. Kumazawa, T., Nakajima, A., Ishiguro, T., Jiuxin, Z., Tanaharu, T., Nishitani, H., Inoue, Y., Harada, S., Hayasaka, I. and Tagawa, Y. (2009): Collaborative work on evaluation of ovarian tox-icity 15) Two-or four-week repeated-dose studies and fertility study of bromocriptine in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP157-SP165.
12. Muskhelishvili, L., Wingard, S.K. and Latendresse, J.R. (2005): Proliferating cell nuclear antigen-A marker for ovarian follicle counts. Toxicol. Pathol., 33, 365-368.
13. Nozaki, Y., Furubo, E., Matsuno, T., Fukui, R., Kizawa, K., Kozaki, T. and Sanzen, T. (2009): Collaborative work on evaluation of ovarian toxicity. 6) Two-or four-week repeated-dose studies and fertility study of cisplatin in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP73-SP81.
14. Ohtake, S., Fukui, M. and Hisada, S. (2009): Collaborative work on evaluation of ovarian toxicity 1) Effects of 2-or 4-week repeated-dose administration and fertility studies with medroxyproges-terone acetate female in rats. J. Toxicol. Sci., 34 (Special Issue I), SP23-SP29.
15. Pedersen, T. and Peters, H. (1968): Proposal for a classification of oocytes and follicles in the mouse ovary. J. Reprod. Fert., 17, 555-557
16. Regan, K.S., Cline, J.M., Creasy, D., Davis, B., Foley, G.L., Lanning, L., Latendresse, J.R., Makris, S., Morton, D., Rehm, S. and Stebbins, K. (2005): STP Position Paper: Ovarian follic-ular counting in the assessment of rodent reproductive toxicity. Toxicol. Pathol., 33, 409-412.
17. Sakurada, Y., Kudo, S., Iwasaki, S., Miyata, Y., Nishi, M. and Masumoto, Y. (2009): Collaborative work on evaluation of ovarian toxicity 5) Two-or four-week repeated-dose studies and fertility study of busulfan in female rats. J. Toxicol. Sci.,34 (Special Issue I), SP65-SP72.
18. Sato, M., Shiozawa, K., Uesugi, T., Hiromatsu, R., Fukuda, M., Kitaura, K., Minami, T. and Matsumoto, S. (2009): Collaborative work on evaluation of ovarian toxicity 7) Effects of 2-or 4-week repeated dose studies and fertility study of cyclophos-phamide in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP83-SP89.
19. Sato, N., Uchida, K., Nakajima, M., Watanabe, A. and Kohira, T. (2009): Collaborative work on evaluation of ovarian tox-icity 13) Two-or four-week repeated dose studies and fertility study of PPAR a/y dual agonist in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP137-SP146.
20. Shibayama, H., Kotera, K., Shinoda, Y., Hanada, T., Kajihara, T., Ueda, M., Tamura, H., Ishibashi, S., Yamashita, Y. and Ochi, S. (2009): Collaborative work on evaluation of ovarian toxicity 14) Two-or four-week repeated-dose studies and fertility study of atrazine in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP147-SP155.
21. Shirai, M., Sakurai, K., Saitoh, W., Matuyama, T., Teranishi, M., Furukawa, T., Sanbuissho, A. and Manabe, S. (2009): Collaborative work on evaluation of ovarian toxicity 8) Two-or four-week repeated-dose studies and fertility study of Anastrozole in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP91-SP99.
22. Shirota, M., Watanabe, G., Taya, K. and Sasamoto, S. (1998): Effect of indomethacin on the selective release of follicle-stimulating hormone during the period of ovulation in the rat. J. Vet. Med. Sci., 60, 1059-1065.
23. Takai, R., Hayashi, S., Kiyokawa, J., Iwata, Y., Matsuo, S., Suzuki, M., Mizoguchi, K., Chiba, S. and Deki, T. (2009): Collaborative work on evaluation of ovarian toxicity 10) Two-or four-week repeated dose studies and fertility study of di-(2-ethylhexyl) phthalate (DEHP) in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP111-SP119.
24. Tamura, T., Yokoi, R., Okuhara, Y., Harada, C., Terashima, Y., Hayashi, M., Nagasawa, T., Onozato, T, Kobayashi, K., Kuroda, J. and Kusama, H. (2009): Collaborative work on evaluation of ovarian toxicity 2) Two-or four-week repeated dose studies and fertility study of mifepristone in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP31-SP42.
25. Tsubota, K., Kushima, K., Yamauchi, K., Matsuo, S., Saegusa, T., Ito, S., Fujiwara, M., Matsumoto, M., Nakatsuji, S., Seki, J. and Oishi, Y. (2009): Collaborative work on evaluation of ovarian toxicity 12) Effects of 2-or 4-week repeated dose studies and fertility study of indomethacin in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP129-SP136.
26. Tsujioka, S., Ban, Y., Wise, L.D., Tsuchiya, T., Sato, T., Matsue, K., Ikeda, T., Sasaki, M. and Nishikibe, M. (2009): Collaborative work on evaluation of ovarian toxicity 3) Effects of 2-or 4-week repeated dose toxicity and fertility studies with tamoxifen in female rats. J. Toxicol. Sci., 34 (Special Issue I), SP43-SP51.
27. Wato, E., Asahiyama, M., Suzuki, A., Funyu, S. and Amano, Y. (2009): Collaborative work on evaluation of ovarian toxici-ty 9) Effects of 2-or 4-week repeated dose studies and fertility study of di(2-ethylhexyl)adipate (DEHA) in female rats. J. Toxi-col. Sci., 34 (Special Issue i), SP101-SP109.
28. Yoshida, M., Sanbuissho, A., Hisada, S., Takahashi, M., Ohno, Y. and Nishikawa, A. (2009): Morphological characterization of the ovary under normal cycling in rats and its viewpoints of ovarian toxicity detection. J. Toxicol. Sci., 34 (Special Issue I), SP189-SP197.