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EC number: 215-687-4 | CAS number: 1344-09-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 16 Mar - 18 Mar 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The method is well-documented, but not yet validated. It is currently in use as an alternative to in vivo eye irritation studies for substances which are shown to be irritating in skin irritation tests.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Reference Type:
- publication
- Title:
- The classification of soluble silicates for eye hazard using the enucleated rabbit eye test.
- Author:
- York, M. et al.
- Year:
- 1 994
- Bibliographic source:
- Toxic. in Vitro 8, 1265-1268
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Principles of method if other than guideline:
- ex vivo rabbit eye irritation study
- GLP compliance:
- yes
- Remarks:
- Environmental Safety Laboratory, Unilever Research, Bedford UK.
Test material
- Reference substance name:
- Silicic acid, sodium salt
- EC Number:
- 215-687-4
- EC Name:
- Silicic acid, sodium salt
- Cas Number:
- 1344-09-8
- Molecular formula:
- Na2O x (SiO2)n with Molar Ratio (MR) (SiO2/Na2O): 1.5 – 4
- IUPAC Name:
- sodium hydroxy(oxo)silanolate
- Details on test material:
- SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio of 2.0, white powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 2 untreated eyes served as control
- Amount / concentration applied:
- undiluted
Amount applied: 50 mg - Duration of treatment / exposure:
- 1 minute(s)
- Observation period (in vivo):
- eyes ex vivo were checked 0.5, 1, 2, 3, and 4 h after treatment for opacification of the cornea and corneal thickness
1 h after treatment fluorescein solution was applied and the rate of fluorescein diffusion into the corneal stroma was assessed togehter with possible corneal damage
4 h after treatment eyes were dissected and corneas underwent histological examination - Number of animals or in vitro replicates:
- 3 rabbit eyes (ex vivo) were treated with the test substance
2 control rabbit eyes (ex vivo) were untreated
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1 min treatment
- Value:
- 4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: 4 = Complete corneal opacity, iris not discernible.
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 1 min treatment
- Value:
- > 0 - < 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: No corneal swelling measurements were taken because of the considerable damage to the corneal surface.
- Irritation parameter:
- other: fluorescein staining
- Run / experiment:
- 1 min treatment
- Value:
- 4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: 4 = Strong - Intense staining of the epithelium and anterior stroma with very rapid diffusion into the remainder of the stroma.
- Irritation parameter:
- histopathological observations
- Run / experiment:
- 1 min treatment
- Value:
- >= 1 - <= 7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: Loss of corneal cell layers: 1-7 (According to the study report, 8 epithelial cell layers are normal.)
Any other information on results incl. tables
AVERAGE SCORE:
- Maximum opacity score:
10 seconds: 1-2 ((1): scattered/diffuse areas of opacity or
loss of corneal epithelium, iris clearly visible/ (2):
easily discernable greyish transculant areas, details of
iris slightly obscured)
60 seconds: 4 (complete corneal opacity, iris not discernable)
- Maximum mean swelling:
10 seconds: 23.26%
60 seconds: Not measurable
- Fluorescein staining:
10 seconds: distinct (pale continous staining of the
epithelium with slow diffusion into stroma)
60 seconds: strong (intense staining of the epithelium and
anterior stroma with very rapid diffusion into the remainder
of the stroma)
- Loss of corneal cell layers:
10 seconds: 3-7
60 seconds: 1-7
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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