Registration Dossier
Registration Dossier
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EC number: 413-650-9 | CAS number: 93971-95-0
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test animals
-Source : David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
-Weight at the start of the study : 2.60-2.78 kg.
-age : approximately twelve to sixteen weeks old at the start of the study.
Environmental cobditions
-Temperature : 17 - 21ºC
-Humidity : 34 - 46%
-Air exchange : approximately 15 changes per hour
-Lighting : 12 fours light and 12 hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL (ca 56 mg)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3, (male:2, female:1)
- Details on study design:
- One rabbit was initially treated. A volume of 0.1 ml of the test material, which was found to weight approximately 56 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given 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".
Any other adverse ocular effects were also noted, Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.
Using the numerical data obtained a modified version of the system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chem., 1962 13 281-289 was used to classify the ocular irritancy potential of the test material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- (animals #1,#2,#3)
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- other: Blue-coloued staining over the nictating membrane
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animals #1,#2,#3)
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animals #1,#2,#3)
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animals #1,#2,#3)
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- other: discharge score
- Basis:
- mean
- Remarks:
- (animals #1,#2,#3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: residual test material
- Irritation parameter:
- other: discharge score
- Basis:
- mean
- Remarks:
- (animals #1,#2,#3)
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: residual test material
- Irritation parameter:
- other: initial pain reaction
- Basis:
- mean
- Remarks:
- (animals #1,#2,#3)
- Score:
- 2
- Irritant / corrosive response data:
- / / Animal #1 / Animal #2 / Animal #3 /
Conjunctive Score (1h) / 8 / 8 / 8 /
Cornea Score (1h) / 0 / 0 / 0 /
IRIS Score (1h) / 5 / 5 / 5 /
Total Score (1h) / 13 / 13 / 13 /
Conjunctive Score (24,48,72h) / 0 / 0 / 0 /
Cornea Score (24,48,72h)) / 0 / 0 / 0 /
IRIS Score (24,48,72h) / 0 / 0 / 0 /
Total Score (24,48,72h) / 0 / 0 / 0 /
Group Mean Score (1h) / 13
Group Mean Score (24,48,72h) / 0
Any other information on results incl. tables
No adverse corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes one hour after treatment. No other adverse iridial effects were noted.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Residual test material was noted around the treated eye of all animals throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The test material produced a maximum group mean score of 13.0 and was classified as a MINIMAL IRRITANT (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit sccording to the EEC labelling regulations and was classified as NON-IRRITANT to the rabbit eye. No symbol and risk phrase are therefore required.
- Executive summary:
In an in vivo eye irritation study in rabbit, the test substance induced MINIMAL IRRITANT (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test substance was classified as NON-IRRITANT to the rabbit eye according to the EEC labelling regulations.
No symbol and risk phrase are required.
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