Toxicity Assessment and Establishment of Acceptable Daily Intake of Fungicide Isotianil

살균제 Isotianil의 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, Kynng-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) ;
  • Hong, Moo-Ki (Agro-Material Safety Evaluating Division, Department of Agro-Food Safety, National Academy of Agricultural Science, Rural Development Administration) ;
  • Lim, Moo-Hyeog (Korea food and drug administration) ;
  • Kim, Young-Bum (Korea Institute of Toxicology) ;
  • Han, Bum-Sook (Hoseo University GLP center) ;
  • Han, Jeung-Sul (Department of Ecological Environment Conservation, Kyungpook National University)
  • 정미혜 (농촌진흥청 국립농업과학원 농산물안전성부 농자재평가과) ;
  • 홍순성 (농촌진흥청 국립농업과학원 농산물안전성부 농자재평가과) ;
  • 박경훈 (농촌진흥청 국립농업과학원 농산물안전성부 농자재평가과) ;
  • 박재읍 (농촌진흥청 국립농업과학원 농산물안전성부 농자재평가과) ;
  • 홍무기 (농촌진흥청 국립농업과학원 농산물안전성부 농자재평가과) ;
  • 임무혁 (식품의약품안전청 식품기준과) ;
  • 김용범 (한국화학연구원 안전성평가연구소) ;
  • 한범석 (호서대학교 GLP센터) ;
  • 한증술 (경북대학교 생태환경보전)
  • Received : 2010.05.09
  • Accepted : 2010.09.27
  • Published : 2010.12.31

Abstract

Isotianil is a fungicide which has prevention effects against rice blast disease. In order to register this new pesticide, the series of toxicity data on animal testing were reviewed to evaluate its hazards to consumers and to determine its acceptable daily intake. Isotianil was almost excreted by urine and feces. It has low acute oral toxicity while has no skin toxicity and ocular irritation. Its skin sensitization was evaluated as slight. Genotoxicity of parent compound and metabolite was negligible. Chronic toxicity tests on rats and dogs showed changes of hematology, clinical biochemistry and liver weight. It had no reproductive and teratogenic effects. The estimation of Acceptable Daily Intake(ADI) is based on the lowest no-observed adverse effect level (NOAEL). The lowest NOAEL of 2.83 mg/kg bw/day was found in the twelve-months rats study. The NOAEL was based on increased liver weight and treatment-related effect on clinica chemistry finding at the nest higher dose level of 2.83 mg/kg bw/day. Therefore, it is considered appropriated to apply an uncertainty factor of 100 to the NOAEL 2.83 mg/kg bw/day from the rat study, resulting in an ADI of 0.028 mg/kg bw/day.

살균제 isotianol의 독성을 평가하고 일일섭취허용량을 설정하기 위하여 급성독성시험 등 시험성적서를 검토하였다. Isotianil은 소변과 대변을 통해 빠르게 대사되었다. 급성경구독성은 저독성이었으며 피부자극, 안점막자극성은 없는 것으로 나타났다. 피부감작성은 약한 감작성으로 판단되었으며, 유전독성은 없었다. 랫드와 개 만성독성시험 결과 간의 무게, 혈액학 및 임상생화학적 변화가 관찰되었다. 또한 생식독성과 기형독성에는 영향이 없었다. Isotianil은 12개월 만성독성시험의 최대무작용량이 2.83 mg/kg/bw/day로 가장 민감하였고, 안전계수 100을 적용하여 일일섭취허용량을 0.028 mg/kg/bw/day로 설정하였다.

Keywords

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