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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:
June 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Food and Drug Administration of the U.S.A. Federal Register (17 September, 1964 § 191. 12)
Deviations:
yes
Remarks:
slight modification, no other description.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 93 mg
Duration of treatment / exposure:
single injection
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: three rabbits eyes irrigated with 20 ml of lukeworm water (approx. 37 °C) 5 seconds after installation and three rabbits eye without rinsing

SCORING SYSTEM:
Cornea
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Complete corneal opacity, iris not discernible 4

Iris
Normal 0
Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

Conjunctivae
Redness (Refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Some vessels definitely injected 1
Diffuse, crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis
No swelling 0
Any swilling above normal (including nictating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 4#, #5 and #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
iris score
Basis:
animal: #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #4 and #6
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
The test material was found to cause no irritation when applied to the rabbit eye mucosa under the conditions of this experiment.
Executive summary:

The substance was evaluated for eye irritation/corrosion according to the "Food and Drug Administration of the U.S.A. Federal Register (17 September, 1964 § 191. 12)". Six rabbits were treated with test material directly injected, three eyes of rabbits were rinsed and three eyes remaining untreated. The mean values at 24/48/72 hour were calculated for the effects on the rinsed eye. The cornea and iris values were 0 in all animals. The conjunctivae redness were 0.67 in two animals (#4 and #6) and 1 in one animal (#5); chemosis were 0.67 (animal #4), 0.33 (animal #5) and 0 (animal #6). All effects observed were reversible within the study period. The effects on the not rinsed eye were comparable to the rinsed one and reversible within the study period.