17α-methyltestosterone (MET) is an aquaculture premix and is only available through Rangen Inc. The primary goal of studies conducted under INAD #8557 is to generate data evaluating the efficacy of MET administered in feed to larval rainbow trout and Atlantic salmon to produce masculinized female fish that produce sperm. The treatment option that is allowed for rainbow trout is a dose of 10.8 mg active drug/kg of fish biomass. MET will be incorporated into feed by Rangen, Inc. at a rate of 3 mg MET/kg feed. MET-medicated feed should be fed to rainbow trout for 60 consecutive days. The treatment option that is allowed for Atlantic salmon is a dose of 6.3 mg active drug/kg of fish biomass. MET will be incorporated into feed by Rangen, Inc. at a rate of 1 mg MET/kg feed. MET-medicated feed should be fed to Atlantic salmon for 105 consecutive days. No retreatment will be allowed. Investigational withdrawal is 120 days. This INAD requires all participants to be approved by the FDA Environmental Team prior to participation – this review will take 100 days. To participate in the INAD Program for MET visit the data collecting site.
Please read the Study Protocol prior to any treatments. It contains the protocol, MSDS, and a copy of the forms to be used as a guide for collecting data that will be entered into the online INAD database. The FDA authorization letter(s) for this INAD is currently only available by emailing Bonnie Johnson .
INAD objective/purpose: Collect supportive and pivotal data needed to establish the effectiveness of 17-α methyltestosterone when fed as a feed additive to larval rainbow trout and Atlantic salmon to produce masculinized female fish that produce sperm.
17-α methyltestosterone (MET)
P.O. Box 706
Buhl, ID 83316
Attention: David Brock
Phone: 1-800-657-6446 x ext. 1332
Target pathogen(s): Not Applicable
Method of administration: Medicated feed treatment
Investigational Withdrawal period:
Required test parameters:
Limitations or restrictions on use of drug:
Required INAD fee: $700/facility/year
AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP