Registration Dossier

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

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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:
data waiving: supporting information
Related information:
Composition 1
Reason / purpose:
data waiving: supporting information
Related information:
Composition 1
Reason / purpose:
data waiving: supporting information
Related information:
Composition 1
Reason / purpose:
data waiving: supporting information
Related information:
Composition 1
Reason / purpose:
other: expert opinion
Related information:
Composition 1
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).