The project period dates from 13th August, 2018 to 31th December, 2019. There are four main objectives in this project include assisting the toxicological and ecotoxicological information review for chemical substances registration, analyzing and evaluating the information items of toxicity and ecotoxicity for chemical substances registration and human resources need for information review, evaluating the toxicological and ecotoxicological alternative test methods and providing administrative support. The main accomplishments of this project are divided into four aspects and are described as follows: Assisting the toxicological and ecotoxicological information review for chemical substances registration: The main task of this project was providing suggestions for application approval, application rejection or application approval with attaching conditions for standard registration. As of 30th November, 2019, 38 cases of review suggestions have been provided to Toxic and Chemical Substances Bureau and 12 consulting cases were also completed. The estimated number of cases was provided to authority for predicting the case number in the following year. The analysis report for evaluating the development and trends of related industry was summit to Toxic and Chemical Substances Bureau in November. Analyzing and reviewing the information items of toxicity and ecotoxicity for chemical substances registration and manpower need for information review: The expert consultation meeting which topic was quantitative structure activity relationship (QSAR) was conducted in November, 2018 and the expert consultation meeting which topic was the current international development of alternative methods and the application direction in Taiwan was conducted in January, 2019. The recommendations for further application of QSAR and development of alternative methods were collected by hosting expert consultation meeting of toxicologist and ecotoxicologist. The expert consultation meeting which topic was the review principles for toxicological information was conducted in October, 2019. The review principles for pathological examination and eyes irritation hazard classification were discussed in this meeting. For assisting the toxicological and ecotoxicological information review for chemical substances registration, two toxicology and chemistry specialist with toxicology or ecotoxicology-related work experience for more than 3 years were hired in this project and both specialists have all gone into the review work. To cooperate with chemical substances registration affairs, the rolling evaluation and revision for the review principles of toxicological information, ecotoxicological information, hazard assessment and exposure assessment are necessary. Based on the review experience, the review principle and management plan for new and existing chemical substances registration information was summited to Toxic and Chemical Substances Bureau. The guidance for hazard assessment and exposure assessment of new chemical substances (draft) was summited to Toxic and Chemical Substances Bureau. These contents of guidance include the hazard and exposure assessment for worker, consumer and environment. Evaluating the toxicological and ecotoxicological alternative test methods: Promoting the development of non-animal test method based on 3R principle (Replacement, Reduction and Refinement) is the domestic and international trend. Compared with traditional toxicological test method using animal as the experimental materials, in vitro and in silico assay could save significant time and resources. On the other hand, with flourishing development of nano materials, it is imperative to develop suitable safety evaluation methods for nanomaterials. For nanomaterials, it is necessary to collect specific identification information to confirm its basic characteristics. The information of toxicological and ecotoxicological alternative test method for chemical substances including nanomaterials was collected in this project and analysis report of review principles and methods for chemical registration information was summited to Toxic and Chemical Substances Bureau. Pentachlorophenol was used as an example to discuss the applicability of QSAR on toxicological and ecotoxicological information. Providing administrative support: The member in this project participated in 2nd annual general meeting and conference holding by the Chinese-Taipei society of Laboratory Animal Sciences in November, 2018 and participated in the Swedish-Taiwan training program on preventive chemicals control in May, 2019. The member in this project also provided administrative support on toxicological and ecotoxicological related businesses to authority.

Toxicological and Ecotoxicological information, Nanomaterials, Alternative Test Methods