Registration Dossier

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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:
1992
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

Constituent 1
Chemical structure
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

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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