ESTRADIOL-17BETA

General Information

Chemical Names: ESTRA-1,3,5(10)-TRIENE-3,17beta-DIOL
CAS number: 50-28-2
Functional Class:
  • Veterinary Drug
    • PRODUCTION_AID

Evaluations

Evaluation year: 2000
ADI: 0-50 ng/kg bw
Comments: The Committee established an ADI of 0-50 ng/kg bw on the basis of the NOEL of 0.3 mg/day (5 µg/kg bw/day) in studies of changes in several hormone-dependent parameters in postmenopausal women. A safety factor of 10 was used to account for normal variation among individuals, and an additional factor of 10 was added to protect sensitive populations. Based on a calculated range of excess intake of total estrogens of 30-50 ng/p/d (< 2% 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: Range of excess intakes total estrogens: 30-50 ng/p/d (< 2% of ADI)
Meeting: 52
Report: TRS 893-JECFA 52/57
Tox Monograph: FAS 43-JECFA 52/43
Residues: FNP 41/12-JECFA 52/37
Previous Years: 1987, TRS 763-JECFA 32/17, FNP 41-JECFA 32/7, NOT PREPARED. ADI UNNECESSARY. ACCEPTABLE RESIDUE LEVEL: UNNECESSARY; HORMONE PRODUCED ENDOGENOUSLY AT VARIABLE LEVELS IN HUMAN BEINGS. RESIDUES FROM USE IN ACCORDANCE WITH GOOD ANIMAL HUSBANDRY PRACTICE UNLIK
Toxicological study
Pivotal Study: Clinical trial in postmenopausal women (Moore et al., 1978): The effects of various dosages of orally administered conjugated estrogens, mestranol, and ethinylestradiol on serum corticosteroid-binding globulin (CBG)-binding capacity was assessed in three healthy postmenopausal women, each of whom received Premarin(R) orally at 0.3, 0.62, 1.2, or 2.5 mg/day for 14 days. Each dose increased serum CBG-binding capacity, but the increase was not significant at 0.3 mg/day.
Animal specie: Human
Effect: Hormonal changes
NOEL: 5 µg/kg bw/day
Point of departure: 5 µg/kg bw/day