Pregna-1,4-diene-3,20-dione, 9-bromo-6-fluoro-11-hydroxy-16-methyl-21-[(1-oxopentyl)oxy]-, (6.alpha.,11.beta.,16.alpha.)-

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1992 to 1993

Justification for type of information:

JUSTIFICATION FOR READ-ACROSS FROM SUPPORTING SUBSTANCE (STRUCTURAL ANALOGUE OR SURROGATE)
For bromhydrin-valerate (CAS No. 54605-02-6) no skin sensitisation data in animals or humans are available. Therefore, human skin sensitisation data of diflucortolone-21-valerate (CAS No. 59198-70-8) were used since these data are regarded as representative. In diflucortolone-21-valerate the bromine atom in position 9 of the target molecule (bromhydrin-valerate) is replaced by a fluorine atom. No other changes in the molecule occured. No relevant toxicological effects are expected by the change of a halogen atom (Br) versus another (F). A search for structure-analogue substances using the QSAR OECD Toolbox 3.4 recommended diflucortolone-21-valerate as one out of 8 category substances for a read-across approach (for additional information see QSAR OECD Toolbox Report on Bromhydrin-valerat in "Attached justification").

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

Materials and methods

Type of sensitisation studied:

skin

Study type:

other: study with patients

Principles of method if other than guideline:

Tests were performed using Finn chambers on Scanpor tape left on the skin of the back for 2 days. The patch tests were read at 2 and 4 days, and reactions were scored in accordance with the International Contact Dermatitis Research Group guidelines (Wilkinson DS et al. (1970): Terminology of contact dermatitis. Acta Dermato-venereologica 50, 287-292).

Test material

Test material information

Constituent 1

Reference substance name:

6α,9-difluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-valerate

EC Number:

261-655-8

EC Name:

6α,9-difluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-valerate

Cas Number:

59198-70-8

Molecular formula:

C27 H36 F2 O5

IUPAC Name:

6 α,9-Difluoro-11 β-hydroxy-16 α-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione

Results and discussion

Results of examinations:

For diflucortolone valerate the relative number of allergic reactions was 1.15 %, compared to hydrocortisone (30.76 %), hydrocortisone-17-butyrate (16.34 %), budesonide (15.06 %) or betamethasone valerate (3.52 %).

Applicant's summary and conclusion

Executive summary:

The authors demonstrated that the number of glucocorticoids allergic reactions is dependent on usage and the intrinsic ability of the glucocorticoid to degrade and bind to arginine. For diflucortolone valerate the relative number of allergic reactions was 1.15 %, compared to hydrocortisone (30.76 %), hydrocortisone-17-butyrate (16.34 %), budesonide (15.06 %) or betamethasone valerate (3.52 %).