[14C] EUGENOL: AEROBIC MINERALIZATION IN SURFACE WATER

[14C]丁香酚：地表水中的好氧矿化 经济合作与发展组织指导意见309需氧 地表水矿化作用--模拟生物降解试验 项目摘要/摘要 新西兰阿基-S有限公司是阿基-S 20E的赞助商，有效成分丁香酚，AS 一种可立即释放的镇静剂，适用于所有鱼种的镇静处理。 条件。美国FDA兽药中心药品注册要求 包括一系列环境安全测试，以完成环境 药物活性的评估，包括表面的好氧矿化分析 水。美国鱼类和野生动物管理局要求立即释放镇静剂 用于评估和测量鱼类种群的现场应用。美国食品和药物管理局要求 为此目的的兽药应注册为新的动物药品。本研究 由环境安全中心环境安全小组设计和同意 兽医将满足这一要求。这项研究将遵循指导方针 在OECD 309中发现的地表水中的好氧矿化-模拟 生物降解性试验。这是一种由OECD国家开发的标准化测试，用于 评估化学品对水环境的影响。 放射性标记的[14C]丁香酚被放置在地表水中以评估 矿化/生物降解过程以及识别和测量代谢物和 评估它们是否会对水环境造成风险，进而对植物群造成风险 和动物，包括人类。研究将遵循良好的实验室操作规范进行 以确保生成的数据符合提交要求。一个FDA- 批准的即刻释放镇静剂将允许美国食品和药物管理局进行必要的现场检查 对鱼类种群进行评估，以确保它们能够满足公众的需求 授权。

[14C] EUGENOL: AEROBIC MINERALIZATION IN SURFACE WATER based on Organization for Economic Co-operation and Development Guidance 309 Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test PROJECT SUMMARY/ABSTRACT AQUI-S New Zealand Ltd. is the sponsor for AQUI-S 20E, active ingredient eugenol, as an immediate release sedative for all finfish species for sedation to handleable condition. US FDA Center for Veterinary Medicine drug registration requirements include a battery of environmental safety tests to complete the environmental assessment of the drug active, including an aerobic mineralization analysis in surface water. The US Fish and Wildlife Service requires an immediate release sedative for field application to assess and measure fish populations. The US FDA requires that a veterinary drug for this purpose shall be registered as a New Animal Drug. This study as designed and concurred by the Environmental Safety Team of the Center for Veterinary Medicine will meet this requirement. The study will follow the Guidance found in OECD 309 Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test. This a standardized test developed by OECD countries for assessing the impact of a chemical on the aquatic environment. Radiolabeled [14C] eugenol is placed in surface water to assess the mineralization/biodegradation process and identify and measure metabolites and evaluate whether they cause a risk to the aquatic environment and subsequently to flora and fauna, including humans. The study conduct will follow Good Laboratory Practices to ensure that the resultant data complies with submission requirements. An FDA- approved immediate release sedative will allow the US FWS to perform necessary field evaluation of fish populations to ensure that they can meet the demands of their public mandate.