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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test animals
-Source : Charles River (UK ) Ltd., Manston, Kent, U.K.
-Weight at the start of the study : males 211-232 g, females 209-222 g.
-age : apporoximately ten to fourteen weeks old at the start of the main study.
Environmental cobditions
-Temperature : 19 - 22ºC
-Humidity : 52 - 63%
-Air exchange : approximately 15 changes per hour
-Lighting : 12 fours light and 12 hours darkness

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
suspension in distilled water
Details on dermal exposure:
A group of five male and five female rats were treated with the test material at a dose level of 2000 mg/kg.
The appropriate amount of the undiluted test material, as received, was pre-weighed into a glass vial.
The test material was then applied uniformly to an area of shorn skin (approximating to 10% of the total body surface area) which had previously been moistened with distilled water.
A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage (HYPERTIE).
The bandage was further secured with a piece of BLENDERM wrapped around each end.
The animals were caged individually for the 24-hour exposure period.
Shortly after dosing the dressings were examined to ensure that they were securely in place.
After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.
The animals were returned to group housing for the rest of the study.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
male : 5, female : 5
Details on study design:
Deaths and overt signs of toxicity were recorded 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Any adverse dermal reactions were also recorded.
Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination.
This consisted of an external examination and opening of the abdominal and thoracic cavities.
The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity or skin irritation were noted during the study.
Blue-coloured staining of the treatment site and fur was commonly noted during the study.
Body weight:
All animals showed expected gain in bodyweight during the study.
Other findings:
Necropsy : No abnormalities were noted at necropsy.

Any other information on results incl. tables

 Table 1 Individual clinical observations, deamal reactions and mortality data
 Dose  Animal  Effects Noted After                    Effects Noted After Initiation of Exposure                             
 Level  Number  Initiation of Exposure                                                            
 mg/kg

 & Sex

 (Hours)          (Days) 
2000    1/2  1  2  4  1 2  3  4  5  6  7  8  9  10  11  12  13  14
360   0  0  0  0  0Fs  0Fs  0Fs 0Fs   0Fs  0Fs 0Fs  0Fs  0Fs  0  0  0  0  0
Male   STA  STA  STA  STA  STA  STA  STA    
 361  0   0   0   0  0Fs  0Fs  0Fs  0Fs  0Fs 0Fs   0Fs  0Fs  0  0  0  0  0   0
 Male  STA  STA  STA  STA  STA  STA  STA  STA
 362  0  0  0  0  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0   0   0   0   0
 Male  STA  STA  STA  STA  STA  STA  STA
 363  0  0  0  0  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs 0Fs  0  0  0  0  0
 Male  STA  STA  STA  STA  STA  STA  STA    
 364  0  0  0  0  0Fs  0Fs  0Fs  0Fs 0Fs  0Fs  0Fs  0Fs  0  0  0   0   0  0 
 Male  STA  STA  STA  STA  STA  STA  STA  STA
 365  0  0  0  0  0Fs  0Fs  0Fs  0Fs 0Fs   0Fs  0Fs  0Fs  0  0 0 0  0  0
 Female  STA  STA  STA  STA  STA  STA  STA  STA
 366  0  0  0  0  0Fs  0Fs  0Fs  0Fs  0Fs 0Fs   0Fs  0Fs  0  0  0  0 0  0 
 Female  STA  STA  STA  STA  STA  STA STA   STA
 367  0  0  0  0  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0  0  0    0    0    0  
 Female  STA  STA  STA  STA  STA  STA  STA  STA
 368  0  0  0   0  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0Fs  0  0  0    0    0    0  
Female  STA  STA  STA  STA  STA  STA  STA  STA
 369  0  0  0  0  0Fs  0Fs 0Fs   0Fs  0Fs  0Fs  0Fs  0Fs  0  0    0    0    0    0  
 Female  STA  STA  STA  STA  STA  STA  STA  STA
 Key :  0 = no signs of systemic toxicity  Fs = fur stained blue  STA = test site stained blue

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg

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