Eugenol: A 96-Hour Static Acute Toxicity Test with the Fathead Minnow (Pimephales promelas) based on Organization for Economic Co-operation and Development Guidance 203 Fish, Acute Toxicity 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 acute toxicity tests to complete the environmental assessment of the drug active, including an acute toxicity test in a designated fish species. 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 203-Fish Acute Toxicity. This a standardized test developed by OECD countries for assessing the impact of a chemical on the aquatic environment. The Fathead Minnow (Pimephales promelas) is exposed for 96 hours in a static bath to varying concentrations of eugenol to assess toxicity. 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: A 96-Hour Static Acute Toxicity Test with the Fathead Minnow (Pimephales promelas) based on Organization for Economic Co-operation and Development Guidance 203 Fish, Acute Toxicity PROJECT NARRATIVE The Environmental Safety Assessment for the registration of veterinary drugs and therapeutants requires that a battery of acute toxicity tests of aquatic life forms, including representative genus/species of algae, invertebrate and vertebrate species be performed. This study uses standardized study guidance (OECD 203) to assess the acute toxicity of eugenol, active ingredient in AQUI-S 20E, to a designated fish species, Fathead Minnow (Pimephales promelas). The study evaluates the acute toxicity of eugenol in the fathead minnow over a 96-hour static batch exposure to varying concentration of the chemical.
