Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

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Administrative data

skin sensitisation: in vivo (LLNA)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
Fluocortolone is a well-known drug substance and constituent of numerous approved drug products which have been in therapeutic use for many decades and therefore the formal data gap is more than compensated by the vast amount of clinical experience gained in its continued and widespread therapeutic use.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
other: expert opinion
sensitisation data (humans)
Type of information:
other: expert opinion
Adequacy of study:
weight of evidence
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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion