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Toxic Impact Analysis by Exposure Duration of Dog Studies for Pesticides using in Korea

국내 사용농약의 노출 기간이 개의 독성반응에 미치는 영향 분석

  • 이제봉 (농촌진흥정 국립농업과학원) ;
  • 정미혜 (농촌진흥정 국립농업과학원) ;
  • 유아선 (농촌진흥정 국립농업과학원) ;
  • 홍순성 (농촌진흥정 국립농업과학원) ;
  • 백민경 (농촌진흥정 국립농업과학원) ;
  • 오진아 (농촌진흥정 국립농업과학원) ;
  • 박경훈 (농촌진흥정 국립농업과학원) ;
  • 임양빈 (농촌진흥정 국립농업과학원)
  • Received : 2013.11.12
  • Accepted : 2013.12.02
  • Published : 2013.12.31

Abstract

Both 13-week and 1-year studies in dog were required for pesticide registration in domestic pesticide control authority. It is raising issue up whether to request 1-year dog study of pesticides using non-food crop. So at this investigation, relevant toxicity test to establish acceptable daily intake (ADI), target organs, difference of no-observed adverse-effect levels (NOAELs) in 13-week and 1-year of 166 active ingredients are analyzed. The data were evaluated to determine if the 13-week dog study and the long term studies in two rodent species (mice and rats) without 1-year dog study were sufficient for the identification of NOAELs and lowest observed adverse effect levels (LOAELs) for the derivation of ADI. Toxicity end points and dose response data from 13 week and 1-year studies were compared. The analysis showed that 68 ADIs of the 166 pesticides were established from dog studies. Major target organs of dog studies were liver in 49 cases, body weight change in 21 cases, cholinesterase inhibition in 16 cases, and alteration in hematology in 14 cases. Similarity of target organ in 13-week and 1-year was 73%. 22 of 40 pesticides had similar critical effects regardless of duration and had NOAELs within a difference of 1.5-fold of each other. For the remaining 18 pesticides, 14 items had lower NOAELs in the 1-year study than 13-week study primarily due to dose selection and spacing. In only 10% of the cases were additional toxic effects identified in the 1-year study that were not observed in the 13-week study.

농약의 등록을 위한 국내 독성시험성적 요구 기준 중 비식용 농약 등 인체노출이 장기적으로 발생되지 않는 물질에 대하여 개 1년 독성시험 성적을 요구할 것인가에 대한 검토를 목적으로 개 13주와 1년 시험성적을 독성학적으로 비교분석 하였다. 본 연구는 최근에 ADI 설정을 위하여 평가한 40종 농약과 기존에 등록된 농약 중 ADI가 고시된 농약 등 총 166종을 대상으로 ADI설정에 사용된 독성시험성적, 주요관련 표적장기, 13주 및 1년의 표적장기 및 영향의 유사성, NOAEL 차이 등을 검토하였다. 그 결과 166종 중 68(41%)종이 개를 이용한 독성시험 NOAEL을 이용하여 ADI를 설정하였고, 표적장기에 대한 영향으로는 간에 대한 영향 49건, 체중변화 21건, 콜린에스테라제 저해 16건, 혈액학적변화 14건 등의 순이었으며, 13주와 1년 시험의 표적장기 및 영향의 유사성은 73%에 달했다. 두 시험 간 NOAEL에 대한 차이는 최근 등록된 40종을 대상으로 분석한 결과 1.5배 이내로 관찰된 것이 22종(55%)으로 가장 많았고 1.6~3.5배가 9종이었다. 나머지 9종에서도 대부분 투여용량 설정 등의 문제였으며 4종(10%)만이 13주 및 1년간에 독성학적 영향이 다른 것으로 나타났다.

Keywords

References

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