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Toxicological information

Eye irritation

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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:
2012
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

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 / 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.