Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
health surveillance data
Type of information:
other: clinical data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: endogenous human steroidal estrogen and approved drug with widespread therapeutic use for many years

Data source

Materials and methods

Study type:
human medical data
Endpoint addressed:
basic toxicokinetics
dermal absorption
acute toxicity: oral
acute toxicity: dermal
skin irritation / corrosion
eye irritation
skin sensitisation
repeated dose toxicity: oral
repeated dose toxicity: dermal
genetic toxicity
carcinogenicity
toxicity to reproduction / fertility
developmental toxicity / teratogenicity

Test material

Constituent 1
Chemical structure
Reference substance name:
Estrone
EC Number:
200-164-5
EC Name:
Estrone
Cas Number:
53-16-7
Molecular formula:
C18H22O2
IUPAC Name:
estrone
Test material form:
other: not applicable for read-across

Results and discussion

Results:
Estrone is an endogenous sex hormone and an approved drug since several decades. The active ingredient, synthetic estrone, is similar both chemically and biologically to endogenously produced human estrone. Estrone belongs to the category “steroidal estrogens” and is one of the pharmacologically less-active metabolites of 17β-estradiol which is the most potent of the naturally occurring estrogens (17ß-estradiol, estrone, estriol).The toxic effects of steroidal estrogens like estradiol <-> estrone are an exaggeration of the normal pharmacological effects and result in an increase of female characteristics. Estradiol and estrone are widely used for oral contraception and in post-menopausal hormonal therapy for many years. Therefore a wide base of clinical experience is available pointing out various types of adverse effects.

Applicant's summary and conclusion