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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
White New Zealand rabbits (3-4 kg) of both sexes, individual housing.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
7 days (eyes were not washed).
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals
Details on study design:
A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.16
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours), conjunctiva score was 2 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). The conjunctiva score was 2 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.
Based on the conjunctiva score of 2 (24, 48 and 72 hours) a classification as Category 2 (irritating to eyes) based on GHS criteria is justified.
Executive summary:

A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days. Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). The conjunctiva score was 2 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.

Based on the conjunctiva score of 2 (24, 48 and 72 hours) a classification as Category 2 (irritating to eyes) based on GHS criteria is justified.