The Korean Journal of Pesticide Science (농약과학회지)

The Korean Society of Pesticide Science (한국농약과학회)
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Issues in 2-year Long-term in vivo Carcinogenicity Assay

2년 장기 발암성 검색법의 이슈

  • Son, Woo-Chan (Huntingdon Life Sciences, Pathology, UK) ;
  • Kim, Bae-Hwan (Pre-clinical Research Center, AMOREPACIFIC R&D CENTER) ;
  • Jang, Dong-Deuk (Division of Toxicological Research, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Han, Beom-Seok (Division of Toxicological Research, National Institute of Toxicological Research, Korea Food and Drug Administration) ;
  • Kim, Jong-Choon (Department of Toxicology, College of Veterinary Medicine, Chonnam National University) ;
  • Lee, Je-Bong (National Institute of Agricultural Science and Technology, Rural Development Administration) ;
  • Shin, Jin-Sup (National Institute of Agricultural Science and Technology, Rural Development Administration) ;
  • Kim, Hyoung-Chin (Lab of Animal Model Evaluation, Korea Research Institute of Bioscience and Biotechnology(KRIBB))
  • 손우찬 ;
  • 김배환 ((주)태평양 기술연구원 전임상연구센타) ;
  • 장동덕 (국립 독성 연구원 독성연구부) ;
  • 한범석 (국립 독성 연구원 독성연구부) ;
  • 김종춘 (전남대학교 수의과 대학 독성학 교실) ;
  • 이제봉 (농업과학 기술원 농산물 안전성부) ;
  • 신진섭 (농업과학 기술원 농산물 안전성부) ;
  • 김형진 (한국생명공학연구원 질환동물모델평가연구실)
  • Published : 2004.12.30
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Abstract

It has been debating about conducting and interpretating of 2-year rodent carcinogenicity bioassay. Although some criticisms arising in usefulness, it has been still known that long-term carcinogenicity studies using rodents would be the only assay system to predict any possible human risks, which would not be replaced. Both regulatory agencies and academies have developed some assay models, however, there have been controversy whether those study designs and interpretations are based on sound scientific rationale and validated data. Such kinds of issues including choice of species/strain, dose level selection, duration of study, number of animals per group, historical control data, monitoring parameters, terminal investigations, peer review, statistics, alternative assay models, interpretation of neoplastic lesions, and risk assessments, were reviewed.

2년 발암성 독성시험의 실시와 평가에 대해서는 많은 논란이 있었다. 2년 발암성 시험의 유용성에 대한 많은 비판에도 불구하고 설치류를 이용한 발암성 시험은 사람의 발암성을 예측 할 수 있는 유일한 평가 시스템으로 인식되어 있으며, 아직 이를 대체할 만한 평가 방법은 없다고 할 수도 있다. 그간 규제기관과 학계에서는 다양한 발암성 평가모델을 제시해 왔지만 이런 시험 모델들이 과학적 타당성과 검증된 데이터에 근거하는지에 대해서는 논란이 있다. 2년 설치류 발암성 시험에 제기되는 문제들 즉, 종 및 품종의 선택, 용량설정, 시험기간, 군당 동물의 수, 배경병변, 검사항목, 시험 종료시 측정항목, 병리의 피어리뷰, 통계, 대체시험 모델, 종양의 평가, 그리고 위해성 평가 등에 대하여 검토하였다.

Keywords

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