LUTEOHORMONE

Overview

Chemical Names
PREGN-4-ENE-3,20-DIONE; DELTA 4-PREGNENE-3,20-DIONE
Synonyms
CORPUS LUTEUM HORMONE; LUTEOHORMONE
CAS number
57-83-0
Functional Class
Veterinary Drug
PRODUCTION_AID

Evaluations

Evaluation year: 2000

ADI:
0-0.03 mg/kg bw

Comments:
The Committee established an ADI of 0-30 µg/kg bw for progesterone on the basis of the LOEL of 200 mg/day (3.3 mg/kg bw) for changes in the uterus. A safety factor of 100 was used to allow for extrapolation from a LOEL to a NOEL and to account for normal variation among individuals. Based on a calculated excess intake of progesterone of 500 ng/p/d (0.03% 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 of progesterone: 500 ng/p/d
Meeting:
52
Report: 
TRS 893-JECFA 52/57
Tox Monograph: 
FAS 43-JECFA 52/43
Residues: 
FNP 41/12-JECFA 52/37

Toxicological study

Pivotal Study:
Clinical trial (Shangold et al., 1991): Sixty women with oligomenorrhea or amenorrhoea received a 10-day course of 200 or 300 mg fine-particle progesterone orally. Withdrawal bleeding occurred in 90% of the women receiving 300 mg progesterone, 58% receiving 200 mg, and 29% of those given placebo. Their lipid concentrations were unchanged.
Animal Specie:
Human
Effect:
Withdrawal bleeding
LOEL:
3.3 mg/kg bw/d
Point of departure:
3.3 mg/kg bw/d
Previous Years:
1987, TRS 763-JECFA 32/19, FNP 41-JECFA 32/18, NOT PREPARED. ADI UNNECESSARY. ACCEPTABLE RESIDUE LEVEL: UNNECESSARY; HORMONE PRODUCED ENDOGENOUSLY AT VARIABLE LEVELS IN HUMAN BEINGS. RESIDUES FROM USE ACCORDING TO GOOD ANIMAL HUSBANDRY PRACTICE UNLIKELY T
1987, TRS 763-JECFA 32/19, FNP 41-JECFA 32/18, NOT PREPARED. ADI UNNECESSARY. ACCEPTABLE RESIDUE LEVEL: UNNECESSARY; HORMONE PRODUCED ENDOGENOUSLY AT VARIABLE LEVELS IN HUMAN BEINGS. RESIDUES FROM USE ACCORDING TO GOOD ANIMAL HUSBANDRY PRACTICE UNLIKELY T