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Diss Factsheets

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: Testing report according to National Act method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Coumarin
EC Number:
202-086-7
EC Name:
Coumarin
Cas Number:
91-64-5
Molecular formula:
C9H6O2
IUPAC Name:
2H-chromen-2-one
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
-Substance type: pure substance
-Storage condition of test material: room tempeature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test animals
-Age at study intiation: 7-9 weeks
-Weight at study intiation: 1-2 kg
-Other conditions: six rabbits in good general health,are used for testing each material. Only one eye of each rabbit is used.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
50mg of powder as supplied.
Duration of treatment / exposure:
96 hours
Test substance are applied to one eye of each of six rabbits by gently pulling he low lid away from the eye ball and placing 50mg in the sac so
formed.
Eyes are examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes are examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured.
Observation period (in vivo):
Assessment of ocular damage/irritation was made 15min and 2,3,4 days following treatment.
Number of animals or in vitro replicates:
six
Details on study design:
All animals are inspected before any treatment and those with spontaneous eye lesions are rejected. Fluorescein is applied to the eye to assist in the detection of corneal lesions. Corneal thickness is also measured before the application of test materials.

The lower eyelid is gently pulled away from the globe and 50mg of test substance applied into the cup so formed. The eyelid is then released.
Assessment of reactions. Animals are carefully watched during and immediately after application of test material for sings of discomfort of pain. If this is excessive or persistent then the animals are immediately killed.
Fifteen minutes after application of test material the eyes are inspected for conjunctival reactions. One day after application of test material and then at daily intervals for five days per week for three weeks or until the eye is considered to be of normal appearance, the eyes are inspected for corneal, conjunctival and irridial reactions. Subjective grades are given to the serverity of the reactions, these are described below. est substance are applied to one eye of each of six rabbits by gently pulling he low lid away from the eye ball and placing 50mg in the sac so formed.
Eyes are examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes are examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured.

Grading of ocular reactions.
Cornea
Normal 0,
Any change from normal, including slight dulling of corneal luster 0.5
Scattered of diffuse areas of opacity, iris clearly visible 1
Easily discernible, grayish, translucent areas, details of iris slightly obscured 2
Grey-white areas, no details of iris visible, size of pupil barely discernible 3
Complete corneal opacity, iris not discernible 4

Iris
Normal 0
Any divergence from normal, congestion of iridial vessels, deepening of folds +

Redness
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 swelling above normal 1
Obvious swelling with partial eversion of eyelids 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 #1
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
0.33
Reversibility:
fully reversible within: 2d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
0.33
Reversibility:
fully reversible within: 2d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
0.67
Reversibility:
fully reversible within: 3d
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24h, 48h, 72h
Score:
1
Reversibility:
fully reversible within: 4d
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24h, 48h, 72h
Score:
1
Reversibility:
fully reversible within: 4d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24h, 48h, 72h
Score:
0.67
Reversibility:
fully reversible within: 3d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Irritant / corrosive response data:
See the following "Any other information on results incl.tables
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, Coumarin(50mg) is not eye irritant.
Executive summary:

Coumarin caused slight conjunctivitis in four animals. Two animals healed within 48hours of treatment, two by day 4. Two animals were unaffected 24 hours after treatment.

However, the test material doesn’t meet the criteria for classification as irritation according to CLP regulation.