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Special Graduate Schools
Graduate School of Clinical Pharmacy and Pharmaceutics
Department of Clinical Pharmacy and Pharmaceutics
3. Theses(Master)
3-Methoxypropanoic acid methyl ester의 Sprague-Dawley 랫드를 이용한 생식/발생독성스크리닝시험
- Author(s)
- 유보라
- Advisor
- 이동주
- Department
- 글로벌제약임상대학원 글로벌제약임상약학과
- Publisher
- The Graduate School, Ajou University
- Publication Year
- 2022-08
- Language
- kor
- Keyword
- 3-Methoxy propanoic acid methyl ester; OECD421; 발생독성; 생식독성; 인체 유해성
- Abstract
- 본 연구는 생산량이 많고 산업현장에서 폭넓게 사용되어 근로자의 건강장해 발생 가능성이 높은 3-Methoxypropanoic acid methyl ester의 생식 및 발달과정에 미치는 시험물질의 영향을 평가하기 위해 시험을 수행하였다. 3-Methoxypropanoic acid methyl ester를 암수 랫드에 0, 160, 400 및 1,000mg/kg 용량으로 수컷은 교미전 14일부터 교배후 14일까지 42일간, 암컷은 교미전 14일부터 분만후 13일까지 약63일간 반복 경구투여 하였다. 시험결과, 관찰기간 중 친세대 수컷 동물에서는 시험물질의 영향으로 보이는 독성은 관찰되지 않았다. 친세대 암컷 동물에서는 1,000mg/kg 투여군의 분만 시 차산자수 및 생존자수 감소, 착상후 손배율 증가가 관찰되어 시험물질의 영향으로 모독성이 초래된 것으로 판단되었다. 차세대 동물에서는 1,000mg/kg 투여군의 체중 감소와 분만 4일째 생존율이 감소하는 경향 및 암컷동물의 항문-성기간거리 증가가 관찰되어 시험물질의 영향으로 인한 발생독성이 초래된 것으로 판단되었다. 160 및 400mg/kg 투여군에서는 시험물질에 의한 영향은 관찰되지 않았다. 결론적으로, 본 시험조건 하에서 친세대와 차세대 동물에 대한 3-Methylpropanoic acid methyl ester의 무독성량(NOAEL)은 친세대 수컷은 1,000mg/kg, 친세대 암컷 및 차세대 암수에서는 모두 400mg/kg으로 판단되었고, 인체에 적용하는 MRSD(Maximum Recommended starting dose)를 계산해보면 성인 60kg 기준으로 친세대 수컷은 967.8mg/60kg/day, 친세대 암컷 및 차세대 암수 모두는 148.8mg/60kg/day로 확인되었다.
- Alternative Abstract
- This study was conducted to evaluate the effect of test substances on the reproduction and development process of 3-Methoxypropanoic acid methyl ester, which is highly productive and widely used in industrial sites and is likely to cause health disorders for workers. 3-Methoxypropanoic acid methyl ester was administered to male and female rats at doses of 0, 160, 400 and 1,000 mg/kg for 42 days from 14 days before mating to 14 days after mating for males, Females were orally administered repeatedly for about 63 days from the 14th day before mating to the 13th day after delivery. As a result of the test, no toxicity was observed in the F0 male animals of the during the observation period. In the F0 female animals, the number of pup and survivors decreased during delivery in the 1,000 mg/kg administration group, and the increase in post-implantation loss rate were observed, and judged to be by the effect of the test substance. In the F1 offspring animals, the weight loss and survival rate of the 1,000 mg/kg administration group decreased on the PND4 of delivery, and the increase in the AGD of female animals were observed, indicating that the toxicity was caused by the effect of the test substance. In the 160 and 400 mg/kg administration groups, the effect of the test substance was not observed. In conclusion, under this experimental conditions, the no observed adverse Effect Level of 3-Methoxylpropanoic acid methyl ester by oral gavage is considered to be 1,000 mg/kg for parent animals males and 400 mg/kg for parent animal females and F1 pups. When calculating the MRSD (Maximum Recommended starting dose) applied to the human body, it was confirmed that, based on an adult 60kg, the parent animal males was 967.8mg/60kg/day, and 400 mg/kg for parent animal females and F1 pups were 148.8mg/60kg/day.
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