In this project, we collected and analyzed the information required in Taiwan chemical substance registration and the alternative testing methods recommended by international organizations to establish the strategy for promoting animal alternative method in our country. Regarding the guidance for Taiwan chemical registration and the latest international guidelines for eye irritation, an optimized draft guidance on how to conduct a hazard classification of eye irritation using alternative methods for chemical substances was proposed. This optimized draft guidance could improve the insufficiency in the previous version, which is the inability to identify the substances that should be classified as category 2. In addition, to improve 2 guidance documents (“Guidance on Alternatives of Acute Dermal Irritation and Corrosion” and “Optimized Guidance on Alternatives of Eye Irritation”), expert opinions from industry, ministries, and academia were collected to fine-tune the guidance. Still, the overall structure has not changed significantly. In this project, we also attempted to analyze the strategy for the safety evaluation of nanomaterials. According to the latest international information, the new testing methods for evaluating the hazard of nanomaterials on human health are still under development. They could be considered for application in the safety assessment once the development is completed. Moreover, to establish and validate the alternatives to animal approaches for environmental assessments. 15 substances were used to conduct the fish cell line acute toxicity test (FCT). The results indicated 8 substances predicted the EC50 effectively. The EC50 of 7 substances (87.5%) obtained from FCT could be considered correct, because the differences between the values of EC50 obtained from FCT and fish acute toxicity test were within 10 times. When compared with embryonic studies, embryo acute toxicity test (FET) showed a better correlation and accuracy (93.3%) than FCT. Furthermore, FCT results were used to optimize the IATA. In the IATA framework, regardless of whether embryos or cell lines were used first, the accuracy rate remains the same. Finally, the implementation effectiveness of the 4-year technology plan was discussed and follow-up strategic planning was proposed. The analysis results of chemical registration information showed that the promotion of alternative testing has been effective in the toxicological evaluations. However, for ecotoxicology evaluations, more efforts are needed to reduce the uses of experimental animals, because the test data of fish toxicity and bioaccumulation were all from traditional animal experiments. Therefore, it is recommended to gradually plan the use of IATA framework to evaluate fish acute toxicity and incorporate more international alternative ecotoxicological testing methods, which could assist registrants to submit their ecotoxicological information obtained from alternative methods. It could help to achieve the goal of further reducing the use of experimental animals.

Replacement, Reduction and Refinement (3Rs), Guidance on Alternative Methods, Integrated Approaches to Testing and Assessment (IATA)