The use of hormones to induce spawning in fish is critical to the success of many U.S hatchery/fisheries programs. During the course of normal spawning operations at a hatchery, it may be necessary to handle and examine individual fish weekly over a 6 - 8 week period. Such procedures can be extremely stressful to valuable brood stock, and compromise their health. Successful hormone treatment can reduce handling requirements to a single hormone administration followed by gamete collection, thereby greatly reducing overall fish handling. Common carp pituitary (CCP) is the most widely used drug to induce final gamete maturation (spawning) in fish. Channel Catfish Pituitary (CP) has also been found to be similarly effective in inducing ovulation and spermiation. Although CP has not been widely used to date, it is readily available in the MS Delta. The US catfish industry is interested in obtaining a CP label to induce final gamete maturation in channel catfish (Icatlurus punctatus) for the production of hybrid catfish (Ictalurus punctatus x Ictalurus furcatus). The specific objective of the proposed project is to evaluate the safety of CP administered via intraperitoneal (IP) injection to adult female channel catfish (Ictalurus punctatus)/group at 0?, 1? (12 mg), 2? (24 mg), and 3? (36 mg) the maximum proposed efficacious dose of CP/kg fish body weight (bw). Ten fish per group will be injected on Days 1 and 2. On Day 3 they will be strip spawned then humanely euthanized. The egg quality will be evaluated and the fish evaluated by pathology and histopathology. The study will be conducted at the Thad Cochran National Warmwater Aquaculture Center Wet Lab in Stoneville MS. The study will be conducted here because the facility has (1) a ready accessible source of channel catfish brood stock (2) sufficient resources to conduct the study e.g. space, water, tanks, necropsy and histopathology facilities, as well as personnel to administer treatment and collect required data) and (3) demonstrated commitment to adhere to the study protocol and other relevant guidelines. The study will be conducted under an FDA CVM accepted pivotal Target Animal Safety (TAS) study protocol (Study Protocol Number CP-12-TAS-CCF) and is intended to provide FDA CVM with sufficient data to complete the TAS portion requirements for approval of CP use in channel catfish. Ultimately the data generated in the study will be used to support a supplemental New Animal Drug Application for the use of CP as a spawning aid in female channel catfish.

Public Health Relevance

The study objective is to evaluate the safety of catfish pituitary (CP) administered via intracoelomic (IC) injection to adult female channel catfish at 0 ; 1 (12 mg); 2 (24 mg); and 3 (36 mg) the maximum proposed efficacious dose of CP/kg fish body weight (bw). Injection of female channel catfish with CP during spawning season will hasten the ripening of eggs which will then be stripped from the females; this will decrease handling of brood stock in hatcheries during spawning season. The results of this safety study; if accepted by FDA/CVM; will be pivotal to complete the TAS technical section data requirements and support a New Animal Drug Application to FDA/CVM to approve the use of CP for this indication: Use as a spawning aid in female channel catfish.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project (R01)
Project #
1R01FD005041-01
Application #
8722120
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2014-02-01
Project End
2015-01-31
Budget Start
2014-02-01
Budget End
2015-01-31
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Mississippi State University
Department
Type
DUNS #
075461814
City
Mississippi State
State
MS
Country
United States
Zip Code
39762