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EC number: 275-060-6 | CAS number: 70955-64-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Code of Federal Regulations
- Version / remarks:
- Code of Federal Regulations, Title 16, Section 1500.42
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
Test material
- Reference substance name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts
- EC Number:
- 275-060-6
- EC Name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts
- Cas Number:
- 70955-64-5
- Molecular formula:
- C36.2H18.9Cl0.7CuN11.5O10.2S3.4Na2.7
- IUPAC Name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[2-[(4-chloro-6-methoxy-1,3,5-triazin-2-yl)amino]ethyl]amino]sulfonyl sulfo derivs., sodium salts
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Blue 71
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 62 mg
- Duration of treatment / exposure:
- The eyes are not washed following instillation of test material
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- 62 mg of Procion Turquoise H-A was instilled into each eye.
Six albino rabbits are used for each test substance. Animal facilities for such procedures shall be so designed and maintained as to exclude sawdust, wood chips, or other extraneous materials that might produce eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye defects or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control. The eyes are not washed following instillation of test material.
The eyes ore examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours. Reading of reaction is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means.
After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution U.S.P. or equivalent is dropped directly on the cornea. After flushing out the excess fluorescein with sodium chloride solution U.S.P. or equivalent, injured areas of the cornea appear yellow; this is best visualized in a darkened room underultra-violet illumination. Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent after the 24 hour reading.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- One animal gave a "positive" reaction.
A corneal opacity was observed in this animal 24 hours after instillation only.
Considerable swelling of the conjunctivae with partial eversion of the eyelids was also observed in this animal at the 24 hours reading only.
Temporary mild conjunctival reactions only were observed in the remaining five animals. - Other effects:
- Staining of the cornea by the dye was observed in two animals.
Any other information on results incl. tables
Numerical scores awarded to the ocular reactions elicited by Procion Turquoise H-A
RABBIT NUMBER |
REGION OF EYE |
DAY |
Positive (+) or Negative (-) Result |
|||||
1 |
2 |
3 |
4 |
7 |
||||
7 |
Cornea |
0 |
0 |
0 |
0 |
0 |
- |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
1 |
0 |
0 |
0 |
0 |
|||
8 |
Cornea |
0 |
0 |
0 |
0 |
0 |
- |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
1 |
0 |
0 |
0 |
0 |
|||
9 |
Cornea |
0 |
0 |
0 |
0 |
0 |
- |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
1 |
1 |
1 |
0 |
0 |
||
Chemosis |
1 |
1 |
1 |
0 |
0 |
|||
10 |
Cornea |
1 |
0 |
0 |
0 |
0 |
+ |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
1 |
0 |
0 |
0 |
0 |
||
Chemosis |
2 |
1 |
0 |
0 |
0 |
|||
11 |
Cornea |
0 |
0 |
0 |
0 |
0 |
- |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
1 |
1 |
1 |
0 |
0 |
||
Chemosis |
1 |
0 |
0 |
0 |
0 |
|||
12 |
Cornea |
0 |
0 |
0 |
0 |
0 |
- |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
1 |
1 |
0 |
0 |
0 |
||
Chemosis |
1 |
1 |
0 |
0 |
0 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Procion Turquoise H-A gave a negative test for eye irritation, according to the definition given in The Code of Federal Regulations.
One animal gave a "positive" reaction. A corneal opacity was observed in this animal 24 hours after instillation only. Considerable swelling of the conjunctivae with partial eversion of the eyelids was also observed in this animal at the 24 hours reading only. Temporary mild conjunctival reactions only were observed in the remaining five animals. The substance is not classifiable according to CLP criteria. - Executive summary:
The procedure employed was that prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42.
On this occasion 62 mg of Procion Turquoise 1-A was instilled into each eye.
One animal gave a "positive" reaction.
A corneal opacity was observed in this animal 24 hours after instillation only.
Considerable swelling of the conjunctivae with partial eversion of the eyelids was also observed in this animal at the 24 hours reading only.
Temporary mild conjunctival reactions only were observed in the remaining five animals.
Staining of the cornea by the dye was observed in two animals.
Procion Turquoise H-A gave a negative test for eye irritation, according to the definition given in The Code of Federal Regulations.
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