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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 40 CFR, Part 798, Subpart E Section 798.4500, Toxic Substances Control Act, 1985
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): APD-1, 3
- Lot/batch No.: DS-06275
- Analytical purity: No data

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right, untreated eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Test substance was not washed from the eye after administration
Observation period (in vivo):
96 hours
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
The eyes were examined at 1, 24, 48, 72 and 96 hours after administration and scored according to the Draize method for scoring ocular lesions

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
The substance was considered to be corrosive.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
The substance was considered to be corrosive.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
The substance was considered to be corrosive.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
The substance was considered to be corrosive.
Irritation parameter:
other: pannus (corneal vascularisation)
Basis:
other: 4/6 animals
Time point:
other: 96 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: The study was terminated when pannus was observed. The substance was considered to be corrosive.
Irritant / corrosive response data:
All six test animals exhibited positive scores for irritation. Fluorescein staining was observed in 5/6 animals. In addition 4/6 animals developed pannus (corneal vascularization) by the 96-hour observation point. The study was terminated when pannus was observed. The control eye of all animals was normal (grade 0) throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Cat. 1, H318
DSD: Xi, R41