Toxicity Assessment and Establishment Acceptable Daily Intake of Lepimectin

레피멕틴(Lepimectin)의 독성평가와 일일섭취허용량 설정

  • Jeong, Mi-Hye (Agro-Material Safety Evaluating Division, Department of Agro-Food Safety, National Academy of Agricultural Science, Rural Development Administration) ;
  • Hong, Soon-Sung (Agro-Material Safety Evaluating Division, Department of Agro-Food Safety, National Academy of Agricultural Science, Rural Development Administration) ;
  • Park, Kyung-Hun (Agro-Material Safety Evaluating Division, Department of Agro-Food Safety, National Academy of Agricultural Science, Rural Development Administration) ;
  • Park, Jae-Eup (Agro-Material Safety Evaluating Division, Department of Agro-Food Safety, National Academy of Agricultural Science, Rural Development Administration) ;
  • Kwack, Seung-Jun (Department of Toxicological Evaluation and Research, National Institute of Food and Drug Evaluation, Korea Food and Drug Administration) ;
  • Kim, Young-Bum (Korea Institute of Toxicology) ;
  • Han, Bum-Seok (GLP center, Hoseo University) ;
  • Son, Woo-Chen (Asan Institute for Life Science, Asan Medical Center)
  • 정미혜 (국립농업과학원 농산물안전성부 농자재평가과) ;
  • 홍순성 (국립농업과학원 농산물안전성부 농자재평가과) ;
  • 박경훈 (국립농업과학원 농산물안전성부 농자재평가과) ;
  • 박재읍 (국립농업과학원 농산물안전성부 농자재평가과) ;
  • 곽승준 (식품의약품 안전평가원 독성평가연구부) ;
  • 김용범 (한국화학연구원 안정성평가연구소) ;
  • 한범석 (호서대학교 GLP센터) ;
  • 손우찬 (아산병원 아산생명과학연구소)
  • Received : 2011.02.10
  • Accepted : 2011.04.11
  • Published : 2011.06.30

Abstract

Lepimectin is a insecticide agent. In order to register this new pesticide, the series of toxicity data on animal testing were reviwed to evaluate its hazards to consumers and to determine its acceptable daily intake. Lepimectin was mostly excreted by feces. It has low acute oral toxicity while it has no dermal, ocular irritation and skin sensitization (As the result of subchronic, chronic toxicity and carcinogenicity showed changes of hematology and clinical biochemistry parameter of serum and blood.). Two-generation reproduction toxicity, genotoxicity, carcinogenicity and prenatal development toxicity were not proven. Therefore, the ADI for Lepimectin is 0.02 mg/kg/ bw/day, based on the NOAEL of 2.02 mg/kg/ bw/day of two-years carcinogenic toxicity study in rats and applying an uncertainty factor of 100.

레피멕틴은 살충제이다. 레피멕틴에 대한 독성을 평가하고 일일섭취허용량을 설정하기 위하여 다양한 인축독성 시험성적서를 검토하였다. 레피멕틴의 대사시험결과, 주로 대변을 통해 배설되었으며, 급성독성은 낮았고, 피부, 안점막자극성과 피부감작성은 없었다. 90일 반복투어경구독성(랫드, 개, 마우스), 만성독성(랫드, 개), 발암성시험(랫드)에서 혈액 및 혈액 생화학적변화를 나타냈으나, 번식독성, 유전독성, 발암성 및 기형독성은 없는 것으로 평가되었다. 따라서, 레피멕틴의 최대무작용량(NOAEL)은 랫드 2년 발암성시혐의 최대무작용량 2.02 mg/kg bw/day로 안전계수 100을 설정하여 일일섭취허용량 0.02 mg/kg bw/day로 설정하였다.

Keywords

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