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EC number: 300-644-5 | CAS number: 93951-21-4
Eye irritation
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- 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
- 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-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Blue 250 (Navy 81-1030)
Constituent 1
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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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
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