Betamethasone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

other: in vitro hapten-specific sensitization method

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Experimental study for the development of an in vitro test for contact allergens. 1. Primary activation of hapten-specific T cells by hapten-conjugated epidermal cells.

Author:

Yokozeki, H.; Katayama, I.; Nishioka, K.

Year:

1995

Bibliographic source:

Int Arch Allergy Immunol 1995, 106, 394-400.

Reference 2

Reference Type:

secondary source

Title:

Experimental study for the development of an in vitro test for contact allergens. 2. Comparison of the in vitro sensitization test with the guinea pig maximization test for contact allergens.

Author:

Arimura, M.; Yokozeki, H.; Katayama, I.; Nakamura, T.; Masuda, M.; Nishioka, K.

Year:

1998

Bibliographic source:

Int Arch Allergy Immunol 1998, 115, 228-234.

Materials and methods

Principles of method if other than guideline:

Mono-layer cultures of Pam 212 cells were incubated with test chemicals (15 min @ 37 °C), washed, then fixed with 3% paraformaldehyde. T cells from non-sensitized mice which had been depleted of autoreactive cells, along with spleen derived macrophages, were cultured with the chemically-modified Pam 212 cells for 5 days. The T cells were then harvested and re-stimulated with mitomycin c treated, hapten-conjugated spleen cells at an R:S of 5:1 for 3 days. A stimulation index (SI) was calculated by dividing the DPM obtained in the presence of hapten modified spleen cells by that obtained in the presence of unmodified spleen cells. A number of chemicals were tested in this culture system including two strong sensitizers (10 mM TNBS, 10 μg/ml DNFB, 0.005% oxazolone, and fluorescein isothiocyanate), two potent sensitizers (2.5 mg/ml p-PD, 2.5% nickel chloride, and 2.5% potassium dichromate), two corticosteroids (0.1% betamethasone and 0.1% budesonide) and one irritant (2.5% methyl salicylate). The SIs produced by the strong sensitizers were approximately 4.0 while the potent sensitizers SIs were around 2.0-2.5.
Betamethasone was able to achieve a SI of 0.98±0.11, lower of many nonsensitizers or irritant compounds.

GLP compliance:

not specified

Type of study:

other: in vitro hapten-specific sensitization method

Test material

Test material information

Constituent 1

Reference substance name:

Betamethasone

EC Number:

206-825-4

EC Name:

Betamethasone

Cas Number:

378-44-9

Molecular formula:

C22H29FO5

IUPAC Name:

9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione

In vivo test system

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

female

Study design: in vivo (LLNA)

Positive control substance(s):

other: Oxazolone

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: In vitro study

Hours after challenge:

72

Group:

other: In vitro study

Dose level:

solution at 0.1%

No. with + reactions:

0

Total no. in group:

0

Clinical observations:

Negative result

Remarks on result:

other: Reading: other: In vitro study. . Hours after challenge: 72.0. Group: other: In vitro study. Dose level: solution at 0.1%. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: Negative result.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Because of the SI obtained for betamethasone (0.98) is lower than 3, with this assay can be excluded the sensitisation potential of betamethasone.
Although this study does not follow the OECD guidelines, the results were considered reliable. Furthermore, the method has been further confirmed by an additional study with more chemicals investigated.