天然植物保護資材商品化研發－毒理試驗運作平臺執行成效

天然植物保護資材常被認為是對人畜安全性與環境友善度較高的產品，為加速這類產品研發上市、補強產品關鍵技術缺口及克服法規登記障礙，農業藥物毒物試驗所（以下簡稱藥毒所）形成跨機關及跨領域之研發團隊（包含毒理學、獸醫學及生物學等專業技術領域人員），共同推動建構天然植物保護資材商品化技術平臺，主要先盤點各試驗改良場所及大專院校較有市場潛力之產品，補強其商品化登記資料，以利產品之技術移轉與登記上市。本文敍述1.生物農藥毒理試驗登記要件與各國法規要件之研析，2.並介紹毒理試驗需求之判斷依據與參考之試驗指引，及各項急性毒性試驗與非目標生物毒性試驗之毒性分類參考標準，3.進行產品登記所需毒理試驗需求之評估與製備。本計畫平臺共盤點26項產品，其中22項產品完成毒理試驗需求評估與毒理試驗資料之製備，共計完成62份符合優良實驗室操作(Good Laboratory Practice, GLP)試驗規範之毒理試驗報告。結果顯示經安全測試與評估後，這些產品均屬於較安全的天然資材產品，其口服急毒性等級均介於輕毒至低毒，惟部分產品如TK99 SC、乳化植物油製劑、五倍子萃取溶液、肉桂油乳劑、液體皂植保製劑、植物油混方、草酸液劑、百里酚蒸散劑及甲酸膠體等9項產品刺激性較強或具潛在皮膚過敏性，施用時需戴護目鏡與手套，並需在產品包裝上加註警語。整體而言，本試驗研究平臺已成功的建立高安全性天然植物保護資材登記典範，從而使登記流程與要件更透明化，並透過此平臺輔導交流，加速研發者完成產品登記所需資料要件，縮短國內登記與上市時程，提高生物農藥市場的選擇性與多樣性，以進而促進有機農業發展。本平臺出具符合國際認可的GLP規範毒理試驗報告，可拓展產品進軍國際市場。未來仍可持續藉由運作此商品化技術平臺，加速各類生物農藥上市及取代部分化學農藥，達成有機化學農藥減量、強化安全使用優質農產品及商品國際化之最終目的。

關鍵字

天然植物保護資材；商品化平臺；毒理試驗； GLP試驗規範；毒性分類標準

並列摘要

Natural pesticides are considered to be safe to humans, other animals, and the surrounding environment. A multidisciplinary team of research specialists (including area of toxicology, veterinary, and biology) was organized by TACTRI to fill research gaps related to key techniques and to help overcome the legal obstacles to product registration. The overall goal of this work was to establish a commercial platform to collect natural pesticides (explored by District Agricultural Research and Extension Station, universities and colleges), and to prepare toxicological data requirements for registration in order to facilitate technology transfer and product launch. The objectives of the project included: 1. Collect international requirements for the registration of biopesticide products; 2. propose related guidelines for toxicity classification and for the testing of acute toxicity and toxicity in non-target organisms; and 3. conduct the required toxicological studies and prepare study reports. Specifically, 26 natural pesticides were selected for this project, and toxicological studies (which included 62 GLP study reports) were completed for 22 of them. Our results revealed that the acute oral toxicity of all 22 tested products fell under the category ＂slightly to practically non-toxic＂; therefore, all these products can be considered safe. However, 9 products, including TK99 SC, emulsified sunflower oil, galla nut Chinese herbal solution, cinnamon oil emulsion, liquid soap plant protectant, plant oil mixture, oxalic acid SL, thymol VP, and formic acid gel, did lead symptoms of strong irritation or skin sensitization; therefore, the labels of these products should include proper warnings, such as the need to wear protective goggles and gloves when applying. Overall, the commercial platform established through this project successfully addressed challenges of getting safe, natural pesticides on the market in a shorter time, including the screening of potential products, safety evaluations of products, and preparation of registration documents. As a result, this platform can produce greater product diversity in the market and improve the development of organic farming while conforming to international market trends through the use of recognized toxicological GLP study reports. In the future, the commercial platform should focus on speeding up market availability of natural biopesticides so that these products can help reduce the use of chemical pesticides, increase the safety of agricultural products, and good enough for international market.

並列關鍵字

natural pesticides ； commercial platform ； toxicological study ； GLP test guidelines ； toxicity classification

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天然植物保護資材商品化研發－毒理試驗運作平臺執行成效

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