재조합 인간상피세포 성장인자(rhEGF, DWP401)가 랫트의 수태능, 태자와 신생자 발달 및 모체기능에 미치는 영향

• 영문명: Fertility and Reproductive & Developmental Toxicity Study on Recombinant Human Epidermal Growth Factor(rhEGF, DWP401) in Rats
• 발행기관: 대한약학회
• 저자명: 박귀례(Kui Lea Park) 한순영(Soon-Young Han) 신재호(Jae-Ho Shin) 이유미(Yoo Mie Lee) 김판기(Pan Gyi Kim) 장성재(Seung Jae Jang)
• 간행물 정보: 『약학회지』제45권 제2호 (2001년), 190~204쪽, 전체 15쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2001.04.30

영문 초록

This study was conducted to investigate for its effects on reproductive and developmental toxicity of recombinant human epidermal growth factor(rhEGF) in Sprague-Dawley rats. Male rats were administered rhEGF at doses of 1,10, 100 and 1000 mcg/kg/day, respectively, by subcutaneous injection from 63 days before and throughout to mating period until the day before sacrifice. Female rats were administered rhEGF at the same doses form 14 days before mating to day 20 of gestation or to day 21 of lactation. We examined the male and female fertility indices and maternal toxicity of F0 parental animals. Also we examined the external, visceral, of skeletal malformation of fetuses, growth and development, behavior, and/or reproductive performance of F1 animals. At the highest dose(1,000mcg/kg), the mean body weights of F0 animals were significantly increased in males and females at 3 or 2 weeks after treatment, respectively. No clinical signs and food intakes were observed at any time during the experimental period by rhEGF treatment. In autopsy examination, the relative and absolute liver weights siginificantly increased in both sexes of 1,000mcg/kg. At the highest dose(1,000mcg/kg), there was a statistically significant increase of pregnancy period and the number of dead fetuses. Moreover, siginificant increase of mean fatal body weight and decrease of number of live fetuses, which related to the difficult delivery were observed in highest dose group. In F1 examination, no adverse effects on external, visceral, and skeletal malformation, physical and functional development, behavior, or reproductive ability of F1 animals were observed in any group. Also there was no significant difference between control and treated groups in copulation or fertility indices of F1 animals. These results indicate that rhEGF had no adverse effect on fertility and reproductive ability of Sprague-Dawley rats.

키워드

rhEGF(DWP401) fertility growth development reproductive toxicity rats.