Drug Research Information Bulletin - The Safety of 17α-Methyltestosterone Administered in Feed to Larval Nile Tilapia

Orally administered 17MT is an efficacious, cost-effective, and efficient way to produce predominantly male populations of tilapia. However, its use in the U.S. for tilapia production depends on its approval by the U.S. Food and Drug Administration (FDA). Approval by FDA requires, in part, that studies be conducted to demonstrate the proposed treatment regimen is safe to target animals. As such, we conducted a study to estimate a margin of safety associated with administering 17MT-treated feed to larval Nile tilapia O. niloticus (mean weight at start of study, 0.032 g) at 0, 9, 27, or 45 mg 17MTper kg fish body weight per d (equivalent to 0×, 1×, 3×, or 5× the proposed maximum efficacious dosage of 9 mg 17MT per kg fish body weight per d) for 28 consecutive days.

Author(s)
Andrew J. Mitchell
Bradley Farmer
Cindy K. Ledbetter
Daniel Carty
David L. Straus
Jim Bowker
Molly P. Bowman
Publication date
Type of document
Fact Sheet
Media Usage Rights/License
Public Domain
Program
A fish with a reddish tone body with black spots on upper part of body, this side view of a Chinook salmon shows the salmon swimming right above a gravel riverbed.
Healthy fisheries are core to the conservation work of the U.S. Fish and Wildlife Service. We are working with partners to protect and enhance the health of fish and other aquatic animals in aquaculture and in the wild.
A man is fishing in a boat with three young girls. The kids are excitedly pulling a fish out of the water.
Healthy fisheries and waters are the foundation of America’s outdoor traditions and give us the freedom to fish, boat, and enjoy the benefits of outdoor recreation. The Fish and Aquatic Conservation programs work with states, tribes, and communities to provide a comprehensive approach to freshwater...
Species
Subject tags
Fishes
Research
Aquaculture
Animal health