Registration Dossier
Registration Dossier
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EC number: 611-173-2 | CAS number: 54605-02-6
Endpoint summary
Administrative data
Description of key information
Neither in vivo studies in animals nor in vitro studies on skin sensitisation are available for bromhydrin-valerate. Data waivers are claimed. Human patch tests with the structural analogue substance diflucortolone-21-valerate (topical corticosteroid) revealed only a low incidence of positive skin reactions after topical application. In addition, the vast amount of clinical experience gained with the approved topical corticosteroid 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:
- other: expert statement
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: 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
The topical corticosteroids diflucortolone-21-valerate and fluocortolone are well-known drug substances and constituents 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 their continued and widespread therapeutic use. - Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: 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 human patch test results with the structural analogue substance diflucortolone-21-valerate as well as the 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 the approved topical corticosteroids diflucortolone-21-valerate and fluocortolone no classification of bromhydrin-valerate is required according to Regulation (EC) No. 1272/2008/EC (CLP).
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