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.
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 NARRATIVE The Environmental Safety Assessment for the registration of veterinary drugs and therapeutants requires that a battery of environmental impact studies be performed. This study uses standardized study guidance (OECD 106) to determine adsorption characteristics of the 14C radiolabeled eugenol on five representative soils. In addition, desorption characteristics will be evaluated in each soil system where significant adsorption is observed and an accurate determination of distribution coefficient at the desorption step is possible.
