Registration Dossier
Registration Dossier
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EC number: 246-529-2 | CAS number: 24916-90-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 20th September 2011 and 22nd September 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- 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 RHC model and are sufficiently cytotoxic to cause cell death in the underlying cell layers.
- 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 / tissue source
- Species:
- human
- Strain:
- other: 4. SkinEthic RHC Model
- Details on test animals or tissues and environmental conditions:
- Using sterile techniques, 800 µL of maintenance medium at room temperature, was dispensed into the appropriate number of wells of 6-well plates designated ‘treatment plates’. Each plate was labelled with details of the treatment and the appropriate
exposure time. Separate treatment plates were used for the test item and negative and positive controls to avoid the possibility of cross contamination occurring. Before treatment, the Day 7 tissues were transferred from the ‘arrival plates’ into the wells of the ‘treatment plates’ containing the maintenance medium.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: See control details in "Study Design" section
- Amount / concentration applied:
- 30 mg of the test item was topically applied to the corresponding tissues
- Duration of treatment / exposure:
- Triplicate tissues were treated with the test item for exposure periods of 10 minutes and 60 minutes
- Observation period (in vivo):
- No Data
- Number of animals or in vitro replicates:
- NA
- Details on study design:
- Duplicate tissues were treated with 30 µL of solution A to serve as negative controls for the 10 and 60-Minute exposure periods. Duplicate tissues were treated with 30 µL of SDS 0.5% w/v to serve as positive controls for the 10 and 60-Minute exposure periods
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Mean OD540
- Time point:
- other: 10 Minutes
- Score:
- ca. 0.939
- Irritation parameter:
- other: Mean OD540
- Time point:
- other: 60 Minutes
- Score:
- ca. 0.943
- Irritant / corrosive response data:
- The relative mean viability of the test item treated tissues was 97.5% after a 10-Minute exposure period and 88.7% after a 60-Minute exposure period.
It was considered unnecessary to proceed with tissue histology.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Due to an equivocal result a Rabbit Enucleated Eye Test, Harlan Laboratories Ltd Project number 41104938(3) was conducted. The results of this study and 41104938 were combined to determine labelling requirements and were considered to be as follows:
Not classified in EU – Mild to moderate irritant Considered GHS: Category 2B.
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