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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 August 2011 and 12 August 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
using the SkinEthic Reconstructed Human Epidermal model
Principles of method if other than guideline:
The test is based on the hypothesis that irritant chemicals are able to penetrate the stratum corneum of the SkinEthic RHE model and are sufficiently cytotoxic to cause cell death in the underlying cell layers. The experimental design of the study consists of a test for direct reduction of MTT by the test item, followed by the main test.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione
EC Number:
246-529-2
EC Name:
9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione
Cas Number:
24916-90-3
Molecular formula:
C22H28O5
IUPAC Name:
9β,11β-epoxy-17,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione
Test material form:
solid: crystalline
Details on test material:
Sponsor's identification : GR46708X
Description : pale yellow crystalline solid
Purity : >98%
Date received : 04 July 2011
Expiry date : 30 June 2012
Storage conditions: room temperature in the dark

Test animals

Species:
other: SkinEthic RHE tissues
Strain:
other: Human
Details on test animals or test system and environmental conditions:
The SkinEthic RHE tissues (Day 18), were stored at room temperature prior to transferring into 6-well plates designated ‘arrival plates’ containing 1 mL of maintenance medium. It was important to ensure that there were no air bubbles present under the tissue inserts. The tissues were incubated overnight at 37°C, 5% CO2 in air

Test system

Type of coverage:
other: SKINETHIC RHE MODEL KIT
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Approximately 25 mg of the test item was topically applied to the corresponding tissues
Duration of treatment / exposure:
4hrs and 24 hrs
Observation period:
No Data
Number of animals:
NA
Details on study design:
Duplicate tissues were left untreated to serve as negative controls for the 4 and 24-Hour exposure periods. Duplicate tissues treated with 50 µL of Triton X-100 (0.1% w/v in distilled water) served as positive controls for the 24-Hour exposure period only.

The maintenance medium from the 24-Hour test and control treatment plates, was retained for possible analysis of the inflammatory mediator levels of IL-1α and IL-8.


The maintenance medium was drawn out of each well, collected into pre-labelled 1.5 mL Eppendorf tubes and stored at -14 to -30oC.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Mean OD540
Time point:
other: 4 hours
Score:
0.843
Irritation parameter:
other: Mean OD540
Time point:
other: 24 hours
Score:
0.83
Irritant / corrosive response data:
The relative mean viability of the test item treated tissues was 108.6% after the 4-Hour exposure period and 99.5% after the 24-Hour exposure period
Other effects:
It was considered unnecessary to proceed with tissue histology or analysis of inflammatory mediator levels.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was considered to be a Non-Irritant. GHS: Considered not to be a significant irritant

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