›› 2012, Vol. 24 ›› Issue (1): 46-49.doi: 10.3969/j.issn.1004-616x.2012.01.011

• 论著 • Previous Articles     Next Articles

Teratogenicity and developmental toxicity of recombinant B lymphocyte stimulating factor receptor– antibody fusion protein (RCT-18) in rats

ZHANG Li-jiang，YOU Zhen-qiang，SONG Yi-sheng，CHEN Yin， CHEN Hao，ZHANG Li-li，HUANG Min，WANG Wen-xiang，FANG Jian-min，XUAN Yao-xian   

  1. 1. National Key Laboratory for Safety Evaluation of New Drugs, Center of Safety Evaluation, Zhejiang Academy of Medical Sciences, Hangzhou 310053, Zhejiang; 2. Rongchang Biotechnologies，Ltd., Yantai 264006, Shandong; 3. School of Life Science and Technology，Tongji University, Shanghai 200092, China
  • Received:2011-04-15 Revised:2011-05-25 Online:2012-01-30 Published:2012-01-30
  • Contact: XUAN Yao-xian

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Abstract: OBJECTIVE: To evaluate the teratogenicity and developmental toxicity of recombinant B lymphocyte stimulating factor antagonist–antibody fusion protein (RCT-18) in Sprague-Dawley (SD) rats. METHODS：Mated female rats were randomly segregated into four groups，including three RCT-18 groups (11，37 and 129 mg/kg) and one negative control group (sodium chloride injection)，with more than 25 rats in each group. RCT-18 was administered via subcutaneous injection to timed pregnant rats on gestation days (GD) 6-15 every two days. Clinical signs，body weights，and feed consumption were monitored during the whole gestation. Caesarean section and autopsy were performed on GD20. Uterine content were evaluated for number of implantations，resorptions，live and dead fetuses. The number of corpora lutea in each ovary was also recorded．Live fetuses were examined for gender，body weights，body lengths，tail lengths，and gross external，visceral and skeletal changes. RESULTS：There were no significant differences in maternal and embryo-fetal parameters. CONCLUSION：No maternal toxicity and embryo-fetal toxicities were found when RCT-18 was administered to SD rats during GD 6–15.

Key words: recombinant B lymphocyte stimulating factor antagonist – antibody fusion protein (RCT-18), teratogenicity, embryo, fetal, developmental toxicity