Registration Dossier

Diss Factsheets

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:
1992
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

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 / 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.