PMID- 15669036
OWN - NLM
STAT- MEDLINE
DCOM- 20050526
LR  - 20191210
IS  - 0260-437X (Print)
IS  - 0260-437X (Linking)
VI  - 25
IP  - 1
DP  - 2005 Jan-Feb
TI  - Developmental toxicity assessment of the new fluoroquinolone antibacterial DW-116 
      in rabbits.
PG  - 52-9
AB  - DW-116 is a newly developed fluoroquinolone antibacterial with a broad spectrum 
      against both Gram-positive and Gram-negative bacteria. We have reported recently 
      that DW-116 is embryotoxic and teratogenic in rats. The present study was 
      conducted to investigate the teratogenicity of DW-116, together with maternal 
      toxicity and developmental toxicity using New Zealand White rabbits. The test 
      chemical was administered by gavage to pregnant rabbits from gestational day (GD) 
      6 through to GD 18 at dose levels of 0, 5, 19.5 and 76.1 mg kg(-1) day(-1). All 
      does were subjected to caesarean section on day 28 of gestation and their 
      foetuses were examined for external, visceral and skeletal abnormalities. In the 
      76.1 mg kg(-1) group, a minimal maternal toxicity, as evidenced by decreased body 
      weight gain during treatment period, was observed in pregnant rabbits. 
      Significant embryo-foetal toxicity, including increased number of foetal deaths 
      and delayed foetal ossification, was seen. However, no treatment-related 
      morphological changes were detected in foetal external, visceral and skeletal 
      examinations. There were no adverse effects on either pregnant dams or 
      embryo-foetal development at 19.5 and 5 mg kg(-1). It was concluded that 
      administration of DW-116 during the major organogenetic period in rabbits 
      produced decreased maternal body weight gain, increased number of foetal deaths 
      and foetal developmental delay but no evidence of teratogenicity. The 
      no-observed-adverse-effect levels (NOAELs) of DW-116 are considered to be 19.5 mg 
      kg(-1) day(-1) for does and embryo-foetuses, respectively.
CI  - Copyright 2005 John Wiley & Sons, Ltd.
FAU - Kim, J C
AU  - Kim JC
AD  - College of Veterinary Medicine, Chonnam National University, Gwangju 500-757, 
      Republic of Korea.
FAU - Kim, S H
AU  - Kim SH
FAU - Shin, D H
AU  - Shin DH
FAU - Bae, C S
AU  - Bae CS
FAU - Oh, K S
AU  - Oh KS
FAU - Kim, J H
AU  - Kim JH
FAU - Yun, H I
AU  - Yun HI
FAU - Lim, J H
AU  - Lim JH
FAU - Chung, M K
AU  - Chung MK
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PL  - England
TA  - J Appl Toxicol
JT  - Journal of applied toxicology : JAT
JID - 8109495
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (DW-116)
RN  - 0 (Fluoroquinolones)
RN  - 0 (Piperazines)
RN  - 0 (Quinolones)
SB  - IM
MH  - Animals
MH  - Anti-Bacterial Agents/chemistry/*toxicity
MH  - Body Weight/drug effects
MH  - *Drug Evaluation, Preclinical
MH  - Embryonic Development/*drug effects
MH  - Female
MH  - Fetal Death/chemically induced
MH  - Fluoroquinolones/chemistry/*toxicity
MH  - Gestational Age
MH  - Molecular Structure
MH  - No-Observed-Adverse-Effect Level
MH  - Piperazines/chemistry/*toxicity
MH  - Pregnancy
MH  - Quinolones/chemistry/*toxicity
MH  - Rabbits
EDAT- 2005/01/26 09:00
MHDA- 2005/05/27 09:00
CRDT- 2005/01/26 09:00
PHST- 2005/01/26 09:00 [pubmed]
PHST- 2005/05/27 09:00 [medline]
PHST- 2005/01/26 09:00 [entrez]
AID - 10.1002/jat.1033 [doi]
PST - ppublish
SO  - J Appl Toxicol. 2005 Jan-Feb;25(1):52-9. doi: 10.1002/jat.1033.