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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Refer to section 'Principles of method if other than guideline'
Principles of method if other than guideline:
Deviation from OECD guideline 405:
- End of the observation period after 8 days.
- No test substance removal.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 50 mg

Observation period (in vivo):
10 min, 1 h, 2 h, 24 h, 48 h, 96 h, 7d and 8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
ca. 3 - ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal: #1 and #2
Time point:
48 h
Max. score:
4
Remarks on result:
other: This time point was not measured
Irritation parameter:
chemosis score
Basis:
animal: # 1 and #2
Time point:
72 h
Remarks on result:
other: This time point was not measured
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 8 d
Score:
ca. 3 - ca. 4
Max. score:
4
Remarks on result:
other: corrosion, ulceration
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
ca. 3 - ca. 4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 8 d
Score:
ca. 3 - ca. 4
Max. score:
4
Remarks on result:
other: corrosion, ulceration
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
48 h
Max. score:
4
Remarks on result:
other: This time point was not measured
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
72 h
Max. score:
4
Remarks on result:
other: This time point was not measured
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 8 d
Score:
4
Max. score:
4
Remarks on result:
other: corrosion, ulceration
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 8 days
Score:
4
Max. score:
4
Remarks on result:
other: corrosion, ulceration
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Max. score:
2
Remarks on result:
other: Not indicated in study report
Irritation parameter:
iris score
Basis:
animal: #1 and #2
Time point:
48 h
Max. score:
2
Remarks on result:
other: This time point was not measured
Irritation parameter:
iris score
Basis:
animal: #1 and #2
Time point:
72 h
Max. score:
2
Remarks on result:
other: This time point was not measured
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 8 d
Max. score:
2
Remarks on result:
other: Not indicated in study report
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Max. score:
2
Remarks on result:
other: Not indicated in study report
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 8 d
Max. score:
2
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Max. score:
3
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 8 d
Max. score:
3
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Max. score:
3
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 8 d
Max. score:
3
Remarks on result:
other: Not indicated in study report
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
48 h
Max. score:
3
Remarks on result:
other: This time point was not measured
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
72 h
Max. score:
3
Remarks on result:
other: This time point was not measured

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this test, test substance causes serious eye damage.
Executive summary:

The eye irritation potential of the test substance was investigated in a study performed equivalent to OECD guideline 405. The unchanged test substance (50 mg) was applied to the eyes of two Vienna White rabbits. The test substance was not removed and the eyes were assessed for irritation after 10 min, 1 h, 2 h, 24 h, 48 h, 96 h, 7d and 8 days. The application of the undiluted substance caused irreversible damage to the eyes of the rabbits. After 8 days the eyes of both animals showed severe edema, as well as corrosion and ulceration were observed. Based on the study results, the test substance causes serious eye damage and has to be classified as eye damaging cat. 1, H318.