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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
Study period:
No information.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, not carried out according to recognised guideline, although results documented.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR 1500.42
Deviations:
not specified
Principles of method if other than guideline:
The acute eye irritation test was determined on 9 young adult albino rabbits, selected from healthy, acclimated animals. The test material at the level of 0,1 ml or 0.1 g was applied to the right eye of each animal. The method employed was patterned after the procedure described in 16 CFR 1500.42.
The test procedure was modified as follows:
Group I: Six rabbits; eyes unwashed following the instillation of the test material.
Group II: Three rabbits; eyes washed 4 seconds following instillation of the test material.
All eyes were observed and ocular reaction recorded at 24,48, and 72 hours after instillation of the test material. They were observed again after 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Specified only as Product No . X-50; Kronitex 50 ; Lot 5-101.
No other information on the test material is provided within the report.

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
9 young adult albino rabbits, selected from healthy, acclimated animals. No other information is detailed within the report.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,1 ml or 0.1 g
Duration of treatment / exposure:
See below.
Observation period (in vivo):
24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
6 unwashed and 3 washed animals
Details on study design:
The acute eye irritation test was determined on 9 young adult albino rabbits, selected from healthy, acclimated animals. The test material at the level of 0,1 ml or 0. 1 g was applied to the right eye of each animal.
The method employed was patterned after the procedure described in 16 CFR 1500.42.
The test procedure was modified as follows:
Group I: Six rabbits; eyes unwashed following the instillation of the test material.
Group II: Three rabbits; eyes washed 4 seconds following instillation of the test material.
All eyes were observed and ocular reaction recorded at 24,48, and 72 hours after instillation of the test material. They were observed again after 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal: 7
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal: 8
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal: 9
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eye - No effects noted
Irritant / corrosive response data:
No ocular effects were observed in any of the animals of either group.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not an irritant to the rabbit eye when not followed by a washout or followed by a washout 4 seconds after instillation of the test material.
Executive summary:

The substance is not an irritant to the rabbit eye when not followed by a washout or followed by a washout 4 seconds after instillation of the test material.

No classification is applicable based on the results.