Registration Dossier
Registration Dossier
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EC number: 276-012-7 | CAS number: 71786-55-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- Clipped by means of an electric clipper
- Vehicle:
- other: DMSO 50%
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours
- Number of animals:
- three male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6.5 cm2
- Type of wrap if used: plastic sleeve
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
Any other information on results incl. tables
Rab. |
Symptom |
30 |
24 h |
48 h |
72 h |
no. 1 male |
Erythema |
0 |
0 |
0 |
0 |
Edema |
1 |
1 |
0 |
0 |
|
no. 2 male |
Erythema |
0 |
0 |
0 |
0 |
Edema |
1 |
0 |
0 |
0 |
|
no. 3 male |
Erythema |
0 |
0 |
0 |
0 |
Edema |
2 |
1 |
0 |
0 |
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.
- Executive summary:
The irritaton was measured by patch test technique on the intact skin.
For erythema the irritation score is 0 in all tested animals.
For edema the irritatione score is 0.3 for #animal1, 0 for #animal2 and 0.3 for #animal3.
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