Registration Dossier

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)

Data source

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

Materials and methods

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

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six New Zealand White rabbits weighing between 1 and 2 Kg and aged 7-9 weeks,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.
Observation period (in vivo):
5d
Number of animals or in vitro replicates:
six
Details on study design:
Test substances are applied to one eye of each of six rabbits by gently pulling the lower lid away from the eye ball and placing 50mg in the sac so formed.

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

Any other information on results incl. tables

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

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.