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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:
1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate
EC Number:
300-644-5
EC Name:
Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate
Cas Number:
93951-21-4
Molecular formula:
C27H27N5O20S6.4Na C27H27N5Na4O20S6
IUPAC Name:
tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Navy 81-1030

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The New Zealand White rabbit, weighing 2 .0 - 3 .0 kg and approximately 9-10 weeks of age, was used for this study.

Husbandry Conditions:
Temperature - 70°F ~ 2°F
Relative Humidity - 45% ~ 5%
Light - 1:2 hour light/dark cycle

Diet - Wayne 15% Rabbit
Ration and tap water were provided ad libitum. Based on our current knowledge no contaminants were known to be in this diet or water that might be expected to interfere with the objectives of the study.

Caging - Stainless steel with elevated wire mesh flooring
1 rabbit/cage

Bedding - Techboard
Shepherd Products Company
Kalamazoo, Michigan 49005

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: approx. 100mg
Duration of treatment / exposure:
single exposure
6 rabbits: test material was not removed
3 rabbits: treated eyes were washed after 30 seconds for 1 minute with gently flowing tepid tap water (1000 mL/minute)
Observation period (in vivo):
The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes.
Number of animals or in vitro replicates:
9
Details on study design:
A 100 mg portion of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The first six rabbits did not have their eyes washed subsequent to instillation. The remaining three rabbits had the treated eyes washed after 30 seconds for 1 minute with gently flowing tepid tap water (1000 mL/minute).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The subject material does not appear to be an ocular irritant in the unwashed eye.
Executive summary:

The New Zealand White rabbit, weighing 2 .0 - 3 .0 kg and approximately 9- 10 weeks of age, was used for this study.

A 100 mg portion of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The first six rabbits did not have their eyes washed subsequent to instillation. The remaining three rabbits had the treated eyes washed after 30 seconds for 1 minute with gently flowing tepid tap water (1000 mL/minute).

The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes. The readings of the eyes were made in accordance with the Draize technique for scoring ocular lesions.

AVERAGE OCULAR IRRITATION SCORE: 0