Registration Dossier
Registration Dossier
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EC number: 609-203-4 | CAS number: 36130-02-6
Endpoint summary
Administrative data
Description of key information
Neither in vivo studies in animals nor in vitro studies on skin sensitisation are available for fluocortolone-21-valerate or fluocortolone. Data waivers are claimed. The vast amount of clinical experience gained with the approved drug substance fluocortolone over many decades gives no evidence that fluocortolone and related substances have a significant skin sensitizing potential.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- 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. - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- other: expert opinion
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For additional information see expert opinion "Assessment of the skin sensitization potential of Fluocortolon (CAS 152-97-6) and related substances (Fluocortolone derivatives)" in chapter 7.10.4 Sensitisation data (humans).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the light of the clinical experience with fluocortolone and related substances no classification is required according to Regulation (EC) No. 1272/2008/EC (CLP).
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.
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