Fact Sheet: 17α-methyltestosterone INAD 11-236

for detailed information, see INAD study protocol, use link on the left
last updated: 1 December 2011

The following links are specific to:

Drug summary & history

List of FDA-Approved drugs

Drug forms to be completed

Examples of completed forms

INAD study protocol

Material Safety Data Sheet

Study Summaries

What's the status of this drug's
(last updated: 18 March 2011)

Print this drug fact sheet

Print all drug fact sheets

Sign-up via the INAD Program Management System (IPMS)

Information on EPA's National Pollutant Discharge Elimination System (NPDES) Permits

Authorization & Categorical Exclusion Letters

Objective/purpose: Collect supportive and pivotal data needed to establish the effectiveness of 17α-methyltestosterone when fed as a feed additive to larval tilapia to produce populations comprising over 90% male fish.
Drug name: 17α-methyltestosterone (MT)
Source of drug: Rangen Inc.
Address: P.O. Box 706
Buhl, ID 83316
Contact: David Brock;
Phone: 1-800-657-6446 x 3332;
Fax: 208-543-8037;
email: dbrock@rangen.com
webpage: http://www.rangen.com/
Target pathogen(s): Not Applicable
Method of administration: Medicated-feed treatment
Treatment dosage: 9 milligrams (mg) MT per kilogram (kg) fish per day

Note: MT will typically be incorporated into standard tilapia feed at a rate of 60 mg MT per kg feed
Treatment regimen: 28 consecutive days
Withdrawal period:

Batch Culture: 120 days (from last day of treatment)

Note: Batch culture is defined as when all fish in a group/lot enter and leave the lot at the same time.

Partial Harvest/Restock Culture: individual minimum weight of 350 grams per fish

Note: Partial harvest/restock culture is defined as the mixing of different lots of fish during the grow-out period and selective harvest from the production unit at various times.

Required test parameters: A minimum of once per calendar year, a minimum of 60 fish must be sampled from a specific treatment lot to determine the sex ration of the population. Investigator should also report general fish behavior and any adverse effects relating to treatment.
Limitations or restrictions on use:

No re-treatment of fish is allowed. Investigator must follow all instructions in the Study Protocol for INAD 11-236 regarding drug acquisition and handling, fish treatment and disposition, and data reporting requirements.

Drug discharge must be in compliance with local NPDES permitting requirements.

Required INAD fee: $600.00 per facility per year
AADAP contact for other information: Ms. Bonnie Johnson, FWS - AADAP
Phone: 406-994-9905
Fax: 406-582-0242

email: bonnie_johnson@fws.gov
Disclaimer: 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.