整合化學品動物替代測試檢驗量能及 發展新興替代測試應用支援計畫
The Project for Integrating the Capacity of Alternatives to Animal Testing and Supporting Development of New Alternative Methods for Chemical Safety Assessment

本年度蒐集國際組織認可之替代測試方法、奈米物質化學品登錄資訊及替代測試方法之最新進展，建立1式優先採納替代測試方法清單，包含3式建議優先納入的替代測試方法，並提出化學物質登錄指引替代測試方法之修正建議。為達到以替代測試方法完備我國化學物質登錄所需毒理及生態毒理資訊之目標，以14種化學物質（7種新及7種既有化學物質）及不同定量結構活性關係(Quantitative Structure-Activity Relationship, QSAR)模式等替代測試方法，試行毒理及生態毒理項目資料推估。在毒理方面，皮膚過敏性及基因毒性皆具有良好的表現；在生態毒理方面，毒性預測軟體工具(Toxicity Estimation Software Tool, T.E.S.T.)之群體貢獻方法(Group contribution method)及生態結構活性關係(Ecological Structure Activity Relationships, ECOSAR)對既有化學物質魚類水生急毒性預測能力表現良好，故建議規劃為整合型測試評估方法(Integrated Approaches to Testing and Assessment, IATA)之基礎模型。體外測試(in vitro assay)部分，本年度完成7種化學物質的體外魚類胚胎試驗，並加入其他13種已知數據的物質，試行結合定量結構活性關係及體外試驗之整合型測試策略，結果顯示分級準確率可達85%。另檢視及評析化學品全球調和制度(Globally Harmonized System of Classification and Labeling of Chemicals, GHS)第8版與中華民國國家標準(Chinese National Standards, CNS) 15030關於替代測試的差異，並提出替代測試方法於化學物質危害分級分類之適用性建議。

In this year, the information about alternative test methods accepted by international organizations, nano-substance registration, and the recent development for alternative test methods was collected and analyzed. According to the information, we established the priority adoption lists of alternative test methods, including 3 recommended protocols. Furthermore, we provided suggestions for revising the guidelines of chemical substances registration. To strengthen the uses of alternative methods in toxicological and eco-toxicological test required by chemical substances registration, quantitative structure-activity relationship (QSAR) models were used to predict the health and environmental hazards of 14 substances (7 new and 7 existing chemical substances). The prediction of all QSAR models we choose for skin sensitization and genotoxicity had good performances. Toxicity estimation software tool (T.E.S.T.) Group contribution method and Ecological structure activity relationships (ECOSAR) models also offered well predictions on classification of acute fish toxicity. In this year, we also confirmed the acute toxicity of 7 substances using Fish Embryo Acute Toxicity (FET) Test. To further improve the accuracy of fish acute toxicity prediction, we try to establish the integrated approaches to testing and assessment (IATA) combining the data from the two QSAR models (T.E.S.T. Group contribution method and ECOSAR) with in vitro data. The accuracy rate of IATA could reach 85% in selected 20 substances. We also analyzed the difference related with alternative test methods between Globally Harmonized System of Classification and Labelling of Chemicals (GHS): 8th Revised Edition and Chinese National Standard (CNS) 15030. The suggestions for applying results of alternative test methods on hazard classification were also provided in this report.