Registration Dossier

Administrative data

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

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