Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-681-6 | CAS number: 68-22-4
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- other: clinical data
- Reliability:
- 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
- carcinogenicity
- toxicity to reproduction / fertility
- developmental toxicity / teratogenicity
Test material
- Reference substance name:
- Norethisterone
- EC Number:
- 200-681-6
- EC Name:
- Norethisterone
- Cas Number:
- 68-22-4
- Molecular formula:
- C20H26O2
- IUPAC Name:
- 17α-Ethynyl-17ß-hydroxy-4-estren-3-one
Constituent 1
Results and discussion
- Results:
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
