Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
health surveillance data
Type of information:
other: clinical data
Adequacy of study:
supporting study
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

Endpoint addressed:
skin sensitisation

Results and discussion

Results:
17 ß-estradiol is an estrogenic hormone occuring naturally in humans. Synthetic 17 ß-estradiol is a well-known drug substance and constituent of numerous approved drug products which have been in therapeutic use for many decades and the vast amount of clinical experience gained in its continued and widespread therapeutic use gives no evidence that 17 ß-estradiol, has a significant skin sensitizing potential.

Applicant's summary and conclusion