Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MCP 922
- Physical state: liquid
- Expiration date of the lot/batch: 06/25/1991
- Stability under test conditions: 2 years under room temperature
- Storage condition of test material: ventilation

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
- Housing: individually housed in suspended cages with wire mesh bottoms
- Diet (e.g. ad libitum): 125g Purina Rabbit Chow No.5326 provided daily
- Water (e.g. ad libitum): ad libitum via an automatic watering system
- Acclimation period: 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-72
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml



Duration of treatment / exposure:
Test substance instilled into left conjunctival sac
Observation period (in vivo):
Both eyes grossly examined and the test eye scored according to the Draize method at 1, 24, 48, and 72 hours after administration. If ulcerations persist at 72 hours the eyes will be observed at 7, 10, 14, and 21 days or until clear. Other observations such as vascular keratitis will also be recorded.
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize Method

TOOL USED TO ASSESS SCORE: Sodium fluorescein 2%

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 28, 72h
Score:
0
Remarks on result:
other: 6 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Remarks on result:
other: 6 animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
2
Remarks on result:
other: 6 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Remarks on result:
other: 6 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24hrs
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48hrs
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72hrs
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1hr
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24hrs
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48hrs
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72hrs
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1hr
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24hrs
Score:
1.2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: 1 out of 6 animals had a score of 2; the rest had scores of 1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48hrs
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72hrs
Score:
0.8
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1hr
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24hrs
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48hrs
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72hrs
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The test material produced 1/6 positive reactions to conjunctival redness according to the FHSA guidelines.
Other effects:
Clinical observations: soft stool, decreased food consumption, and decreased fecal output was noted in one or more animals. The mean corenal opacity, iritis conjuntivae redness and chemosis mean scores following grading at 24, 48, and 72 h for animal #1 were 0,0,1,1 animal #2 were 0,0,0.6,1; animal #3 were 0,0,1,1; animal #4; 0,0,1.2,1; animal #5 were 0,0,1,1; and animal #6 were 0,0,1,1. Conclusions on revesibility are limited based on the lenght of the study (concluded after 72h)

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, iritis, conjunctivae redness, and chemosis scores for the test material were 0, 0, 1 and 1, respectively. These findings do not warrant classification of the test material 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 test material was administered to the left eye of three male and three female rabbits to assess for ocular irritation. Ocular examinations occurred at 1h, 24h, 48h, 72h post-dosing and the animals were observed for remaining ocular lesions day 7, 14, 21, or until clear. Ocular damage was assessed and scored according to the Draize eye test. The mean corneal opacity, iritis, conjunctivae redness, and chemosis scores for the test material at each time point were all less than or equal to one for 5 out of 6 animal. One animal had a scoreof 2 for conjunctivae redness at 24 hours. The mean corenal opacity, iritis conjuntivae redness and chemosis mean scores following grading at 24, 48, and 72 h for animal #1 were 0,0,1,1 animal #2 were 0,0,0.6,1; animal #3 were 0,0,1,1; animal #4; 0,0,1.2,1; animal #5 were 0,0,1,1; and animal #6 were 0,0,1,1. Conclusions on revesibility are limited based on the length of the study (concluded after 72h). These findings do not warrant classification of the test material 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.