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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:
1986
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:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male or female Hew Zealand White rabbits

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid).
Duration of treatment / exposure:
One application
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored by the attached system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Additional readings are made, if necessary, at 14 and 21 days. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
0.8
Max. score:
1
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
14 d
Score:
1.3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
21 d
Score:
1
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
1.2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
14 d
Score:
0.5
Max. score:
1
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
21 d
Score:
0.5
Max. score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
14 d
Score:
0.3
Max. score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
21 d
Score:
0.2
Max. score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0.5
Max. score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
7 d
Score:
1.5
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
14 d
Score:
0.7
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
21 d
Score:
0.8
Max. score:
2
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Persistent, minor, diffuse corneal opacity in 6 of 6 eyes, iritis in 6, moderate to severe conjunctival irritation in 6 from 0.005 ml; conjunctival necrosis, instances of corneal vascularization observed; 3 healed, 3 still injured at 21 days.