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EC number: 413-650-9 | CAS number: 93971-95-0
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Test Animals
- Source : David Hall Limited, Staffordshire, U.K.
- Weight at study initiation : 368 - 475 g
Environmental Conditions
- Temperature : 19 - 23 ºC
- Humidity : 51 - 63%
- Air exchange : approximately 15 changes per hour
- Photoperiod : 12 hours light and 12 hours darkness
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Selection of Concentrations for Main Study (Sighting Tests):
Intradermal Induction
1%, 5%, 10% or 25% w/v in distilled water.
Topical Induction
25%, 10%, 5% and 2% w/w in distilled water.
Topical Challenge
25%, 10%, 5% and 2% w/w in distilled water.
Main Study
Induction :
A row of three injections (0.1 ml each) was made. The injection were
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) a 10% (w/v) dilution of test material in distilled water.
iii) a 10% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
One week later 0.2 -0.3 ml of the test material formulation (25% w/w in distilled water)
Challenge : 0.1 -0.2 ml of the test material formulation (25% w/w in distilled water)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Selection of Concentrations for Main Study (Sighting Tests):
Intradermal Induction
1%, 5%, 10% or 25% w/v in distilled water.
Topical Induction
25%, 10%, 5% and 2% w/w in distilled water.
Topical Challenge
25%, 10%, 5% and 2% w/w in distilled water.
Main Study
Induction :
A row of three injections (0.1 ml each) was made. The injection were
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) a 10% (w/v) dilution of test material in distilled water.
iii) a 10% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
One week later 0.2 -0.3 ml of the test material formulation (25% w/w in distilled water)
Challenge : 0.1 -0.2 ml of the test material formulation (25% w/w in distilled water)
- No. of animals per dose:
- test: 20
control:10 - Details on study design:
- The method used for assessing the sensitising properties of the test material was based on the Guinea Pig Maximisation test of Magnusson B. & Kligman A.M., J. Invest. Dermatol. (1969) 52: 268-276.
Selection of Concentrations for Main Study (Sighting Tests)
a) Selection of Concentration for Intradermal Induction
Four animals were intradermally injected with preparations of test material (1%, 5%, 10% or 25% w/v in distilled water).
The highest concentration that did not cause local necrosis, ulceration or systemic toxicity, was selected for the intradermal induction stage of the main study.
b) Selection of Concentration for Topical Induction
Two guinea pigs (intradermally injected with Freund's Complete Adjuvant eighteen days earlier) were treated with four preparations of the test material (25%, 10%, 5% and 2% w/w in distilled water).
The highest concentration producing only mild to moderate dermal irritation after a 48-hour occulusive expousure, was selected for the topical induction stage of the main study.
c) Selection of Concentration for Topical Challenge
Four preparations of the test material (25%, 10%, 5% and 2% w/w in distilled water) were applied occlusively to the flanks of two guinea pigs for a period of 24 hours.
The highest non-irritant concentration of the test material was selected for the topical challenge stage of the main study.
Main Study
Induction of the Test animals:
A row of three injections (0.1 ml each) was made on each side of the mid-line. The injection were:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) a 10% (w/v) dilution of test material in distilled water.
iii) a 10% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
one week later (Day 7), the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the test material formulation (25% w/w in distilled water). The test material formulation (0.2 - 0.3 ml) was applied on filter paper which was held in place by a strip of surgical adhesive tape and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a strip of elastic adhesive bandage wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 48 hours.
Erythematous reactions were quantified one and twenty-four hours following removal of the patches using the 0 - 3 scale.
Induction of the Control Animals:
Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) distilled water.
iii) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
The topical applications followed the same procedure as for the test animals except that the vehicle alone was applied to the filter paper. Skin reactions were quantified as for the test animals. - Challenge controls:
- Shortly before treatment on Day 21, an area, approximately 50 mm x 70 mm on both flanks of each animal, was clipped free of hair with veterinary clippers.
A quantity of 0.1 - 0.2 ml of the test material formulation (25% w/w in distilled water) was applied to the shorn right flank of each animal on a square of filter paper which was held in place by a strip of surgical adhesive tape. The vehicle alone was similarly applied to the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured by a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
After 24 hours, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. The position of the treatment sites was identified by using ablack indelible marker-pen. - Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrochlorobenzene
Results and discussion
- Positive control results:
- 89% (16/18) sensitisation rate
This was considered to be a satisfactory sensitisation response for this material under the condition of the test.
In vivo (non-LLNA)
Resultsopen allclose all
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (w/w) Challenge concentration
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- slight blue-coloured staining
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 25% (w/w) Challenge concentration. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: slight blue-coloured staining.
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (w/w) Challenge concentration
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- slight blue-coloured staining
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: test group. Dose level: 25% (w/w) Challenge concentration. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: slight blue-coloured staining.
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 25% (w/w) Challenge concentration
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- slight blue-coloured staining
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: other: control group. Dose level: 25% (w/w) Challenge concentration. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: slight blue-coloured staining.
- Hours after challenge:
- 48
- Group:
- other: control group
- Dose level:
- 25% (w/w) Challenge concentration
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- slight blue-coloured staining
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: other: control group. Dose level: 25% (w/w) Challenge concentration. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: slight blue-coloured staining.
Any other information on results incl. tables
a) Skin Reactions Observed After Topical Induction
Dark blue-coloured staining caused by the test material was noted at all treatment sites one and 24 hours following dressing removal.
The staining prevented accurate evaluation of erythema.
b) Skin Reactions Observed After Topical Challenge
Slight blue-coloured staining caused by the test material was noted at all test sites at the 24 and 48-hour observations.
This did not affect evaluation of erythema.
No adverse reactions were noted at the test material and vehicle control sites of the test or control animals at the 24 and 48-hour observations.
Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The test material produced a 0% (0/20) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin.
The test material was also classified as a non-sensitiser according to EEC labelling regulations. No risk phrase is therefore required. - Executive summary:
Non-sensitiser
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