Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

health surveillance data
Type of information:
other: clinical data
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 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
repeated dose toxicity: oral
repeated dose toxicity: dermal
genetic toxicity
toxicity to reproduction / fertility
developmental toxicity / teratogenicity

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:

Results and discussion

Norethisterone is an exogenous sex hormone and active ingredient of approved drugs since several decades. Norethisterone belongs to the category “progestin/progesteron”. Norethisterone has progestogenic properties resembling those of the naturally occuring progesterone but is a more potent inhibitor of ovulation. Norethisterone and norethisterone enanthate/acetate are widely used for oral contraception and in hormon replacement therapy for many years. Therefore a wide base of clinical experience is available pointing out various types of effects.

Applicant's summary and conclusion