Registration Dossier
Registration Dossier
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EC number: 276-012-7 | CAS number: 71786-55-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Copper, [[[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]amino]sulfonyl]-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts
- EC Number:
- 276-012-7
- EC Name:
- Copper, [[[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]amino]sulfonyl]-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts
- Cas Number:
- 71786-55-5
- Molecular formula:
- cannot be displayed for UVCB
- IUPAC Name:
- Copper, ((((3-((5-chloro-2,6-difluoro-4-pyrimidinyl)amino)phenyl)amino)sulfonyl)-29H,31Hphthalocyaninato (2-)-kappaN29,kappaN30,kappaN31,kappaN32)-, aminosulfonyl sulfo derivs., sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: single cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 30%-70%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): light/dark cycle was 12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 24, 48, 72 hours
- Number of animals or in vitro replicates:
- Three male rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 #2 #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1 #2 #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 48/72 h
- Score:
- 0
- Max. score:
- 2
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to CLP (CE) n. 1272/2008 criteria
- Conclusions:
- The test substance is considered to be a non-irritant according to CLP (CE) n. 1272/2008 criteria.
- Executive summary:
The test substance was used undiluited. The eyes of three male rabbits were examined for pre-existing casual injury. 100 mg of the test substance was placed into the conjunctival sac of the right eyes of the animals. The eyelids were then gently held together for two seconds. the left eyes served as control. The eyes were inspected after 24, 48, 72 hours.
The test substance is considered to be a non-irritant according to CLP (CE) n. 1272/2008 criteria.
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