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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:
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:
1993
Reference Type:
publication
Title:
The classification of soluble silicates for eye hazard using the enucleated rabbit eye test.
Author:
York, M. et al.
Year:
1994
Bibliographic source:
Toxic. in Vitro 8, 1265-1268
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2004
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
Name:
Unnamed
Type:
Constituent
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

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