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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study according TG OECD 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Gelbpigment E4GN was administered at a dose of 100 mg into one eye of 3 rabbits. The eye reactions were observed and registerd up to 72 hours after application of the test item.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test Item: Gelbpigment E4GN

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.55
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Other effects:
no data

Any other information on results incl. tables

Under the present test conditions, a single administration of 100 mg Gelbpigment E4GN per animal into the conjunctival sac of the right eye of three rabbits caused following changes:

Conjunctival redness (grade 1) was observed in all animals 60 minutes and 24 hours after administration, in animal nos. 1 and 3 until 48 hours after administration.

The corneae and irises were not affected by administration of the test item.

There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Gelbpigment E4GN was administered at a dose of 100 mg into one eye of 3 rabbits. The eye reactions were observed and registerd up to 72 hours after application of the test item.

Under the present test conditions, a single administration of 100 mg Gelbpigment E4GN per animal into the conjunctival sac of the right eye of three rabbits caused following changes:

Conjunctival redness (grade 1) was observed in all animals 60 minutes and 24 hours after administration, in animal nos. 1 and 3 until 48 hours after administration. The corneae and irises were not affected by administration of the test item.

Therefore a classification is not justified.