Registration Dossier
Registration Dossier
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EC number: 246-529-2 | CAS number: 24916-90-3
Skin irritation / corrosion
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:
- 2 011
- 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
- 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
Constituent 1
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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