TESTOSTERONE
Overview
Chemical Names
17 beta-HYDROXYANDROST-4-EN-3-ONE; delta-4-ANDROSTEN-17beta-OL-3-ONE
Synonyms
trans-TESTOSTERONE
CAS number
58-22-0
Functional Class
Veterinary Drug
PRODUCTION_AID
PRODUCTION_AID
Evaluations
Evaluation year: 2000
ADI:0-0.002 mg/kg bw
ADI:
0-0.002 mg/kg bw
Comments:
The Committee established an ADI of 0-2 µg/kg bw for testosterone on the basis of the NOEL of 100 mg/day (1.7 mg/kg bw/day) in the study of eunuchs and a safety factor of 1000. The large safety factor was used in order to protect sensitive populations and because of the small number of subjects in the study from which the NOEL was identified. Based on a calculated excess intake of testosterone of 60 ng/p/d (0.05% of ADI), the Committee concluded that there was no need to specify MRL values when the drug was used in accordance with good veterinary practices.
MRL Comment:
MRLs: Muscle, liver, kidney and fat (cattle): NOT SPECIFIED
MRL Code:
MRL
Intake:
Excess intake: 60 ng/p/d (0.05% of ADI)
Meeting:
52
Report:
Tox Monograph:
Residues:
Toxicological study
Pivotal Study:
Double-blinded, placebo-controlled clinical trial (Johnsen et al., 1974): Eunuchs (n=5) received a 0, 100 mg/day, 400 mg/day (100 mg four times a day). The reported NOEL was 100 mg/d.
Animal Specie:
Human
Effect:
Restoration normal sexual desire, erection, ejaculation, and general well-being
NOEL:
1.7 mg/kg bw/day
Point of departure:
1.7 mg/kg bw/day
Previous Years:
1987, TRS 763-JECFA 32/21, FNP 41-JECFA 32/24, NOT NECESSARY. ACCEPTABLE RESIDUE LEVEL: UNNECESSARY; HORMONE PRODUCED ENDOGENOUSLY AT VARIABLE LEVELS IN HUMAN BEINGS. RESIDUES FROM USE ACCORDING TO GOOD ANIMAL HUSBANDRY PRACTICE UNLIKELY TO POSE A HAZARD
1987, TRS 763-JECFA 32/21, FNP 41-JECFA 32/24, NOT NECESSARY. ACCEPTABLE RESIDUE LEVEL: UNNECESSARY; HORMONE PRODUCED ENDOGENOUSLY AT VARIABLE LEVELS IN HUMAN BEINGS. RESIDUES FROM USE ACCORDING TO GOOD ANIMAL HUSBANDRY PRACTICE UNLIKELY TO POSE A HAZARD