Registration Dossier

Diss Factsheets

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 fluocortolone and related substances and there is a very low incidence of positive patch test reactions compared to the very substantial therapeutic use in patients with skin diseases. 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 fluocortolone and structurally related substances are unlikely to be significant skin sensitizers and the criteria for classification are not met.