Registration Dossier
Registration Dossier
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EC number: 413-650-9 | CAS number: 93971-95-0
Toxicological information
Acute Toxicity: dermal
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:
- 1 992
- 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
- 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
- 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
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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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