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EC number: 413-650-9 | CAS number: 93971-95-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- 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 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes
- Limit test:
- no
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 (U.K.) Limited, Manston, Kent, U.K.
- Weight at study initiation : male 135 - 171 g, female 127 - 163 g
Environmental Conditions
- Temperature : 16 - 22 ºC
- Humidity : 38 - 73%
- Air exchange : at least 15 changes per hour
- Photoperiod : 12 hours light and 12 hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The absorbance was measured at 695 nm in 1 cm cells using chloroform as the reference medium.
The test material formulations were analysed in triplicate within three days of preparation.
Nominal / Mean / Mean concentration / Range / Range /
concentration / concentration / expressed / (mg/ml) / expressed /
(mg/ml) / found (mg/ml)/ as % of nominal / / as % of nominal /
-------------------------------------------------------------------------------
3.75 / 3.89 / 104 / 3.72-4.13 / 99-110 /
37.5 / 37.8 / 101 / 36.1-38.5 / 96-103 /
250 / 258 / 103 / 244-270 / 98-108 / - Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- The test material was administered daily, for twenty-eight consecutive days.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Doses level : 0(control), 15, 150 and 1000 mg/kg/day, Treatment volume : 4 ml/kg, Concentration : 0(control), 3.75, 37.5, 250 mg/mL
Basis:
other: nominal in vehicle
- No. of animals per sex per dose:
- Test groups per dose male:5, female:5
control group mail:5, female:5
Examinations
- Observations and examinations performed and frequency:
- a) Clinical signs : observe immediately befor dosing and one hour after dosing at weekends.
b) Bodyweight : start of treatment ( day 0) and days seven, fourteen, twenty-one and twenty-eight.
c) Food consumption : at weekly intervals
d) Water consumption : daily
e) Laboratory investigations i) Haematology and ii) Blood chemistry : end of the study (day 28)
f) Pathology i) Organ weights and ii) Histopathology : end of the study (day 28)
- Sacrifice and pathology:
- i) Organ Weights
ii) Histopathology - Statistics:
- Absolute and relative organ weights, haematological and blood chemical data were analysed by one way analysis of variance incorporating 'F-max' test for homogeneity of variance.
Data showing heterogeneous variances were analysed using Kruskal Wallis non-parametric analysis of variance and Mann Whitney U-Test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no deaths during the study.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no deaths during the study.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Bodyweight gain in test animals was comparable with that seen in controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No adverse effects on food consumption were detected.
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- No overt intergroup differences were detected.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were detected.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No clinically observable signs of toxicity were detected in test or control animals throughout the study period.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were detected.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No treatment-related microscopic changes were observed.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Mortality data, Clinical observations, Bodyweight, Food consumption, Water consumption, Haematology, Blood chemistry, Necropsy, Organ weight, Histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Blood chemistry : No treatment-related effects were detected.
Necropsy : No treatment-related macroscopic abnormalities were detected.
Table 1 : Group mean haematological values and standard deviations (sd) - Males
|
Table 2 : Group mean haematological values and standard deviations (sd) - Females
|
Table 5 : Group mean relative organ weights (% of bodyweight) and standard deviations (sd) - Males
* = significantly different from control group value p =< 0.05 ** = significantly different from control group value p =< 0.01
Table 6 : Group mean relative organ weights (% of bodyweight) and standard deviations (sd) - Females
|
Applicant's summary and conclusion
- Conclusions:
- Oral administration of the test material for twenty-eight consecutive days in the rat at dose levels of up to 1000 mg/kg/day, produced no toxicologically significant changes in the parameters measured.
- Executive summary:
NOEL (No Observed Effect Level) : 1000 mg/kg/day
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