Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: expert opinion
Adequacy of study:
weight of evidence

Data source

Reference
Reference Type:
other: company data
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

Overall there is proven broad exposure related to the therapeutic topical use of norethisterone related substances in transdermal therapeutic systems and there is only one isolated positive patch test reaction of unclear relevance published, compared to the substantial therapeutic use in postmenopausal patients.

Therefore based on the available reliable and relevant human data the assessment of the skin sensitization potential (hazard identification) is possible. Based on all available data there is no evidence of skin sensitization properties of norethisterone and structurally related substances.