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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD 405. GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
last observation timepoint at 72 hr
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MCP 917
- Physical state: colorless homogeneous liquid
- Expiration date of the lot/batch: 04/01/1994
- Stability under test conditions: stable for 5 years at room temperature
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc (Denver PA)
- Age at study initiation: young adult
- Weight at study initiation: ~ 2.0-4.0 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Single instillation; the eyelids were gently held together for one second
Observation period (in vivo):
Clinical observations were recorded at approximately 1 and 4 hours post-dosing and daily thereafter except on weekends.
Number of animals or in vitro replicates:
3 per sex
Details on study design:
SCORING SYSTEM: Draize method: Evaluations were made at 1, 24, 48, and 72 hours.

TOOL USED TO ASSESS SCORE: sodium fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
male
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
female
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
female
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
male
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
male
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
female
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
female
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
male
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
male
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
female
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
female
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
female
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
female
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
male
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
male
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
female
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
female
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
male
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
male
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
female
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
female
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
female
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
male
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritant / corrosive response data:
Mean DRAIZE scores for six animals at 24, 48 and 72 hrs respectively:
Corneal Opacity: 0, 0, 0
Iris Lesion: 0, 0, 0
Conjunctivae: 5.7, 3.3, 1.7

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the study substance were 0, 0, 0.9, and 0.4, respectively. These findings do not warrant classification of the study substance as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The study substance was administered to one eye of six New Zealand White rabbits to assess for ocular irritation; the other eye was used as a control. Clinical observations were made 1 and 4 hours immediately after treatment and daily thereafter. Ocular damage was assessed and scored according to the Draize method. Mild conjunctival redness and/or swelling were noted in all animals at 24 and/or 48 hours post-dosing. Discharge was noted sporadically throughout the study. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the study substance were 0, 0, 0.9, and 0.4, respectively. These findings do not warrant classification of the study substance as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.