[14C] EUGENOL: AEROBIC MINERALIZATION IN SURFACE WATER

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[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.