[14C] EUGENOL: AEROBIC MINERALIZATION IN SURFACE WATER

[14C] 丁子香酚：地表水中的好氧矿化

• 批准号: 8788760
• 负责人: William J Brock
• 金额: $ 5.71万
• 依托单位: AQUI-S NEW ZEALAND, LTD
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-10 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8788760
• 关键词: 14C; EUGENOL; AEROBIC; MINERALIZATION; SURFACE

[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.

[14C]丁香酚：基于地表水中的有氧矿物质 经济合作与发展指南组织309有氧运动 地表水中的矿化 - 模拟生物降解测试 项目摘要/摘要 Aqui-s新西兰有限公司是Aqui-S 20E，活性成分Eugenol的赞助商 对所有鳍鱼物种的镇静剂，用于镇静的镇静剂 健康）状况。美国FDA兽医药物注册要求 包括一系列环境安全测试以完成环境 评估活性药物的评估，包括表面上的有氧矿化分析 水。美国鱼类和野生动植物服务需要立即释放镇静剂 现场应用以评估和测量鱼类种群。美国FDA要求 为此目的，兽药应注册为一种新的动物药物。这项研究 正如中心环境安全团队设计和同意的 兽医医学将满足这一要求。该研究将遵循指导 在经合组织309中发现的有氧矿物质在地表水中 - 模拟 生物降解测试。这是经合组织国家开发的标准化测试 评估化学物质对水生环境的影响。 放射性标记的[14C]丁香醇被放置在地表水中以评估 矿化/生物降解过程，并识别和测量代谢物以及 评估它们是否对水生环境造成风险 和动物群，包括人类。研究行为将遵循良好的实验室实践 确保所得数据符合提交要求。 FDA- 批准的即时释放镇静剂将允许美国FW执行必要的领域 评估鱼类种群，以确保他们可以满足公众的要求 授权。