Registration Dossier
Registration Dossier
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EC number: 601-489-9 | CAS number: 1176-81-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
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
Reference
- Endpoint:
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
