Registration Dossier
Registration Dossier
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EC number: 413-650-9 | CAS number: 93971-95-0
Toxicological information
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phthalocyanine-N-[3-(diethylamino)propyl]sulfonamide copper complex
- EC Number:
- 413-650-9
- EC Name:
- Phthalocyanine-N-[3-(diethylamino)propyl]sulfonamide copper complex
- Cas Number:
- 93971-95-0
- Molecular formula:
- Can not be identified
- IUPAC Name:
- hexacopper(2+) 5-{[3-(diethylamino)propyl]sulfamoyl}-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 6,14-bis({[3-(diethylamino)propyl]sulfamoyl})-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 6,15-bis({[3-(diethylamino)propyl]sulfamoyl})-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 6-{[3-(diethylamino)propyl]sulfamoyl}-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 7-{[3-(diethylamino)propyl]sulfamoyl}-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 8-{[3-(diethylamino)propyl]sulfamoyl}-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test animals
-Source : David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
-Weight at the start of the study : 2.27-2.55 kg.
-age : twelve to sixteen weeks old at the start of the study.
Environmental cobditions
-Temperature : 18 - 22ºC
-Humidity : 50 - 60%
-Air exchange : approximately 15 changes per hour
-Lighting : 12 fours light and 12 hours darkness
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: moistened with distilled water
- Controls:
- not required
- Amount / concentration applied:
- A quantity of 0.5g of the test material, moistened with 0.6 ml of distilled water, was introduced under a 2.5cm x 2.5cm gauze patch and placed in position on the shorn skin.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3, (male:1, female:2)
- Details on study design:
- A quantity of 0.5g of the test material, moistened with 0.6 ml of distilled water, was introduced under a 2.5cm x 2.5cm gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water followed by diethyl ether.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining, desaquamation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: faint blue-coloured staining
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Sum of 24 and 72-hours readings (s) : 2
Primary Irritation Index (s/6) : 2/6 = 0.3
Classification : Mild Irritant - Other effects:
- Faint blue-coloured staining was noted at all treated skin sites during the study. This did not affect evaluation of skin responses.
Very slight erythema was noted at one treated skin site one hour after patch removal and at two treated skin sites at the 24 and 48-hour observations.
Very slight oedema was confined to one treated skin site one hour after patch removal.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Treated skin sites appeared normal 48 to 72 hours after treatment.
The test material produced a primary irritation index of 0.3 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material was also classified as non-irritant according to EEC labelling regulations. No symbol and risk phrase are required. - Executive summary:
No corrosive effects were noted.
The test material was also classified as non-irritant according to EEC labelling regulations.
No symbol and risk phrase are required.
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