Developmental toxicity assessment of the new fluoroquinolone antibacterial DW-116 in rabbits

Journal of Applied Toxicology

Volumn 25, Issue 1, 2005, Pages 52-59

  Kim, J C ^a   Kim, S H ^a   Shin, D H ^a   Bae, C S ^a   Oh, K S ^a   Kim, J H ^b   Yun, H I ^c   Lim, J H ^c   Chung, M K ^d  

^a Chonnam National University   (South Korea)

^b Chonnam National University Medical School   (South Korea)

^c Chungnam National University   (South Korea)

^d Korea Institute of Toxicology   (South Korea)

Author keywords

Antimicrobial agents; DW 116; Embryotoxicity; Quinolones; Rabbits; Teratogenicity

Indexed keywords

1 (5 FLUORO 2 PYRIDYL) 6 FLUORO 7 (4 METHYL 1 PIPERAZINYL) 1,4 DIHYDRO 4 OXOQUINOLONE 3 CARBOXYLIC ACID; FANDOFLOXACIN; QUINOLINE DERIVED ANTIINFECTIVE AGENT; UNCLASSIFIED DRUG;

ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BONE MALFORMATION; CONTROLLED STUDY; DOSE RESPONSE; EMBRYOTOXICITY; FEMALE; FETOTOXICITY; FETUS; FETUS DEATH; FETUS DEVELOPMENT; GROWTH RETARDATION; NONHUMAN; PRIORITY JOURNAL; RABBIT; TERATOGENICITY; TOXICITY TESTING;

ANIMALS; ANTI-BACTERIAL AGENTS; BODY WEIGHT; DRUG EVALUATION, PRECLINICAL; EMBRYONIC DEVELOPMENT; FEMALE; FETAL DEATH; FLUOROQUINOLONES; GESTATIONAL AGE; MOLECULAR STRUCTURE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PIPERAZINES; PREGNANCY; QUINOLONES; RABBITS;

NEGIBACTERIA; ORYCTOLAGUS CUNICULUS; POSIBACTERIA;

EID: 13244275206     PISSN: 0260437X     EISSN: None     Source Type: Journal    
DOI: 10.1002/jat.1033     Document Type: Article

References (40)

1. Chahoud I, Ligensa A, Dietzel L, Faqi AS. 1999. Correlation between maternal toxicity and embryo/fetal effects. Reprod. Toxicol. 13: 375-381.
2. Chernoff N, Rogers JM, Kavlock RJ. 1989. An overview of maternal toxicity and prenatal development: considerations for developmental toxicity hazard assessments. Toxicology 59: 111-125.
3. Choi KH, Hong JS, Kim SK, Yoon SJ, Choi EC. 1997. In-vitro and in-vivo activity of DW-116, a new fluoroquinolone. J. Antimicrob. Chemother. 39: 509-514.
4. Chung MK, Kim JC, Han SS. 2002. Developmental toxicity of flupyrazofos, a new organophosphorus insecticide, in rats. Food Chem. Toxicol. 40: 723-729.
5. Cuffini AM, Tullio V, Allocco A, Paizis G, De Leo C, Carlone NA. 1994. Effect of rufloxacin upon non-specific immune defences: in-vitro, ex-vivo and in-vivo results. J. Antimicrob. Chemother. 34: 545-553.
6. Dawson AB. 1926. A note on the staining of the skeleton of cleared specimens with Alizarin Red S. Stain Technol. 1: 123-124.
7. Gootz TD, Brighty KE. 1998. Chemistry and mechanism of action of the quinolone antibacterials. In The Quinolones, Andriole VT (ed.). Academic Press: San Diego; 29-80.
8. Hooper DC, Wolfson JS. 1991. Fluoroquinolone antibacterial agents. New Engl. J. Med. 324: 384-394.
9. Hwang YH, Han KO, Lee J, Yang HB, Chung YH, Yoon SJ, Lee DK. 1997. In vitro and in vivo antibacterial activity of DW-116, a new quinolone antibiotic. J. Appl. Pharmcol. 5: 187-193.
10. Kaneda M, Fujii S, Aoyama H, Teramoto S. 1993. Usefulness of a simplified artificial insemination technique in the rabbit for teratology studies. Exp. Anim. 42: 217-220.
11. Karabalut N, Drusano GL. 1993. Pharmacokinetics of the quinolone antibacterial agents. In Quinolone Antimicrobial Agents, Hooper DC, Wolfson JS (eds). American Society of Microbiology. New York; 195-223.
12. Kavlock RJ, Chernoff N, Rogers EH. 1985. The effect of acute maternal toxicity on fetal development in the mouse. Teratogen. Carcinogen. Mutagen. 5: 3-13.
13. Khera KS. 1985. Maternal toxicity: a possible etiological factor in embryo-fetal deaths and fetal malformations of rodent-rabbit species. Teratology 31: 129-153.
14. Khera KS. 1987. Maternal toxicity in human and animals: effects on fetal development and criteria for detection. Teratogen. Carcinogen. Mutagen. 7: 287-295.
15. Kim JC, Yun HI, Shin HC, Han SS, Chung MK. 2000. Embryo lethality and teratogenicity of a new fluoroquinolone antibacterial DW-116 in rats. Arch. Toxicol. 74: 120-124.
16. Kim JC, Bae JH, Kim IH, Chung MK, Han SS. 2001a. Historical control data for developmental toxicity study in New Zealand White rabbits. Kor. J. Lab. Anim. Sci. 17: 47-58.
17. Kim JC, Shin HC, Cha SW, Koh WS, Chung MK, Han SS. 2001b: Evaluation of developmental toxicity in rats exposed to the environmental estrogen bisphenol A during pregnancy. Life Sci. 69: 2611-2625.
18. Kim JC, Bae CS, Kim SH, Yun HI, Park SC, Shin HC, Han J, Chung MK. 2003. Transplacental pharmacokinetics of the new fluoroquinolone DW-116 in pregnant rats. Toxicol. Lett. 142: 103-109.
19. Lee DK. 1995. Pharmacokinetic study of a new quinolone, DW-116. Drugs 49: 323-325.
20. MARTA (Middle Atlantic Reproduction Teratology Association). 1997. Appendix B: historical control data. In Handbook of Developmental Toxicology, Hood RD (ed.). CRC Press: New York; 716-724.
21. Matsuzawa T, Nakata M, Goto I, Tsushima M. 1981. Dietary deprivation induces fetal loss and abortion in rabbits. Toxicology 22: 255-259.
22. Morinaga T, Fujii S, Furukawa S, Kikumori M, Yasuhira K, Shindo Y, Watanabe M, Sumi N. 1996. Reproductive and developmental toxicity studies of prulifloxacin (NM441) (3): a teratogenicity study in rabbits by oral administration. J. Toxicol. Sci. 21(Suppl. 1): 207-217.
23. Morita H, Ariyuki F, Inomata N, Nishimura K, Kasegawa Y, Miyamoto M, Watanabe T. 1987. Spontaneous malformations in laboratory animals: frequency of external, internal and skeletal malformations in rats, rabbits and mice. Cong. Anom. 27: 147-206.
24. Neu HC. 1992. Quinolone antimicrobial agents. Annu. Rev. Med. 43: 465-486.
25. NRC (National Research Council). 1996. Guide for the Care and Use of Laboratory Animals. National Research Council. National Academy: Washington, DC.
26. Park YH, Jung BH, Chung BC, Park J, Mitoma C. 1997. Metabolic disposition of the new fluoroquinolone antibacterial agent DW116 in rats. Drug Metab. Dispos. 25: 1101-1103.
27. Petrere JA, Rohn WR, Grantham LE II, Anderson JA. 1993. Food restriction during organogenesis in rabbits: effects on reproduction and the offspring. Fundam. Appl. Toxicol. 21: 517-522.
28. Shimada J, Hori S. 1992. Adverse effects of fluoroquinolones. Prog. Drug Res. 38: 133-143.
29. Stahlmann R, Lode H. 1999. Toxicity of quinolones. Drugs 58(Suppl. 2): 37-42.
30. Stuckhardt JL, Poppe SM. 1984. Fresh visceral examination of rat and rabbit fetuses used in teratogenicity testing. Teratogen. Carcinogen. Mutagen. 4: 181-188.
31. Suzuki T, Ishikawa S, Ogawa Y, Takahashi T, Abe Y. 1990. Teratological study of fleroxacin in rabbits. Chemotherapy 38(Suppl. 2): 272-279.
32. Takayama S, Watanabe T, Akiyama Y, Ohura K, Harada S, Matsuhashi K, Mochida K, Yamashita N. 1986. Reproductive toxicity of ofloxacin. Arzneim. Forsch. 36: 1244-1248.
33. Takayama S, Hirohashi M, Kato M, Shimada H. 1995. Toxicity of quinolone antimicrobial agents. J. Toxicol. Environ. Health 45: 1-45.
34. Umemura T, Sasa H, Lizuka T, Yanagita T. 1988. Teratological study of oral administration of NY-198 in rabbits. Chemotherapy 36(Suppl. 2): 391-410.
35. Walker RC. 1999. The fluoroquinolons. Mayo Clin. Proc. 74: 1030-1037.
36. Watanabe T, Fujikawa K, Harada S, Ohura K, Sasaki T, Takayama S. 1992. Reproductive toxicity of the new quinolone antibacterial agent levofloxacin in rats and rabbits. Arzneim. Forsch. 42: 374-377.
37. Wise LD, Beck SL, Beltrame D, Beyer BK, Chahoud I, Clark RL, Clark R, Druga AM, Feuston MH, Guittin P, Henwood SM, Kimmel CA, Lindstrom P, Palmer AK, Petrere JA, Solomon HM, Yasuda M, York RG. 1997. Terminology of developmental abnormalities in common laboratory mammals (Version 1). Teratology 55: 249-292.
38. Wolfson JS, Hooper DC. 1991. Overview of fluoroquinolone safety. Am. J. Med. 91: 153S-161S.
39. Yamada T, Ohsawa K, Ohno H. 1988. The usefulness of alkaline solutions for clearing the uterus and staining implantation sites in rats. Exp. Anim. 37: 325-331.
40. Yu IL, Chung SJ, Lee MH, Shim CK. 1997. Pharmacokinetics of 1-(5-fluoro-2-pyridyl)-6-fluoro-7-(4-methyl-1-piperazinyl)1,4-dihydro-4- oxoquinolone-3-carboxylic acid hydrochloricle (DW-116), a new quinolone antibiotic in rats. J. Pharmacol. Sci. 86: 550-553.