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
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
according to Federal Register, Vol. 29, No. 182, p 13009, 17 Sept 1964
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The other eye, remaining untreated, seves as a control. The eyes are not washed following instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no corneal effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: iris was not affected in any animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: one day
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 48 and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: no conjuctival effects observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 24 hours
Score:
0.16
Max. score:
4
Reversibility:
fully reversible within: one day
Remarks on result:
other: one animal affected grade 1
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 1-6
Time point:
other: 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no chemosis observed
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: no discharge observed at any time point

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information