Method of Administration
Required INAD Fee
Drug History and Summary
The current label for hydrogen peroxide (H2O2) use in aquaculture limits use to: 1) freshwater-reared fisnfish eggs to control mortality due to saprolegniasis; 2) freshwater-reared salmonids to control mortality due to bacterial gill disease; and 3) freshwater-reared coolwater finfish and channel catfish to control mortality due to external columnaris disease. The approved label limits the overall utility of H2O2 use in aquaculture because it has been shown to effectively control mortality caused by other important fish diseases and reduce infestation of a number of different external parasites.
External parasites form one of the largest groups of pathogenic organisms of cultured aquatic species (Post 1987). Affected species include finfish (freshwater and marine) and invertebrates. Environmental conditions such as temperature change, poor water quality, and high organic loading due to intensive fertilization and feeding levels increase the incidence and spread of many external parasites. Stress (e.g., seining, handling, sorting, grading, vaccinating, anesthesia, crowding, and transport) can also be a major contributor to most parasitic outbreaks in fish (Lasee 1995). Additionally, tissue damage induced by external parasites increases susceptibility to secondary bacterial and/or fungal infections.
The organisms responsible for major parasitic infections on fish are, for the most part, protozoan and metazoan. The parasites affecting the external surface of fish typically include those of the genera Ambiphrya, Chilodonella, Cleidodiscus, Dactylogyrus, Epistylis, Gyrodactylus, Ichthyobodo, Ichthyophthirius, Trichodina, and Trichophrya. These parasites are highly opportunistic and have tremendous reproductive capabilities. Under normal conditions (e.g., in wildstock populations) these organisms cause little pathology. However, under intensive culture where fish densities are typically high, many of these organisms can cause serious disease problems.
If parasitic infections are left untreated, they can cause substantial economic losses to commercial aquaculture, and severely impact the restoration, recovery, and preservation of depleted stocks of fish cultured by Federal and State agencies. The extent of losses of fish from parasites depends upon the severity of the primary cause of infection. Morbidity can vary from less than 10% to total loss of the population. Historically, immersion treatments (static and flush) using a variety of compounds, including H2O2, have been used to control mortality caused by parasite infestations. A number of these compounds have been found, both experimentally and under production settings, to be relatively effective.
The primary goal of field studies conducted under INAD #11-669 is to generate additional H2O2 efficacy data which can be used to expand the current H2O2 label claim. Under this INAD, Western Chemical is the only authorized supplier of H2O2 to Investigators under this INAD. Four treatment options are allowed, and regardless of the treatment option used, fish may be slaughtered for harvest or stocked immediately after treatment.
Please see the H2O2 study protocol for all cited references.
Collect supportive and pivotal data needed to establish the effectiveness and safety of 35% PEROX-AID® to control mortality caused by ectoparasites in a variety of fish species.
Ectoparasites of the genera Ambiphrya, Chilodonella, Dactylogyrus, Epistylis, Gyrodactylus, Ichthyobodo, Ichthyophthirius, Trichodina, Trichophrya, Argulus, Salmincola, Lernaea, and Ergasilus in freshwater fish species; and of the genera Neobenedenia, Amyloodinium, Cryptocaryon, and Uronema in marine fish species.
Required Test Parameters
Investigator must collect mortality data throughout the 5 day pre-treatment, treatment, and 10 day post-treatment periods. Investigator should also report general fish behavior and any possible adverse effects relating to treatment.
Restrictions on Use
Investigator must follow all instructions in the Study Protocol for INAD 11-669 regarding drug acquisition and handling, fish treatment and disposition, and data reporting requirements.
100 or 150 miligram (mg/L)
50, 75 or 100 miligram (mg/L)
200 miligram (mg/L)
400 miligram (mg/L) - saltwater sea cages
30 min; 3 consecutive or alternate days
60 min; 3 consecutive or alternate days
30 min; 3 consecutive or alternate days
45 min; once per week for saltwater fish in open-water sea cages
None. Fish may be allowed to enter the food chain immediately after treatment.
Data Collection and Reporting
The following drug forms are intended primarily to provide Investigators a guide as to the type of data that must be collected during a study. In some cases, Investigators may deem the forms appropriate for the collection of raw data. However, it is extremely important to note that all data must be entered (and submitted) using the INAD Program Management System (online database). Drug Forms
Product and company names mentioned in this website, or mentioned in materials accessed via this website, are for informational purposes only. The mention of such does not imply endorsement by the Aquatic Animal Drug Approval Partnership, the U.S. Fish & Wildlife Service or any other organization of the U.S. Government.