EUGENOL: ADSORPTION/DESORPTION CHARACTERISTICS IN REPRESENTATIVE SOILS

丁香酚在土壤中的吸附/解吸特性 基于经济合作与发展组织的代表性土壤 开发指南106采用间歇平衡法进行吸附-解吸 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 对药物活性的评估，包括对 具有代表性的土壤/沉积物类型。美国鱼类和野生动植物管理局要求 即刻释放的镇静剂，用于现场应用，以评估和测量鱼类种群。 美国FDA要求，用于此目的的兽药应注册为 新的动物药。这项研究是由环境安全局设计并同意的 兽医中心的团队将满足这一要求。这项研究将 遵循OECD 106《使用批次吸附-解吸》中提供的指导 平衡法。这是一种由OECD国家开发的标准化测试，用于 评估化学物质对环境的影响。 在研究设计中，将放射性标记的14C-丁香酚混合到各种土壤类型中以 评估化学物质是否会吸附在土壤上。在吸收将会 这项研究将进一步确定该化学物质从土壤中的解吸情况。这个 研究行为将遵循良好的实验室实践，以确保所产生的数据 符合提交要求。FDA批准的速释镇静剂 将允许美国食品和药物管理局对鱼类种群进行必要的实地评估 确保他们能够满足其公共授权的要求。

EUGENOL: ADSORPTION/DESORPTION CHARACTERISTICS IN REPRESENTATIVE SOILS based on Organization for Economic Co-operation and Development Guidance 106 Adsorption - Desorption Using a Batch Equilibrium Method 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 adsorption/desorption analysis in representative soil/sediment types. 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 106 Adsorption - Desorption Using a Batch Equilibrium Method. This a standardized test developed by OECD countries for assessing the impact of a chemical on the environment. For the study design radiolabeled 14C-eugenol is mixed into a variety of soil types to assess whether the chemical will adsorb to the soil. In cases where absorption would occur the study will further determine desorption of the chemical from the soil. 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.