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EC number: 209-378-3 | CAS number: 574-93-6
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- ; no clinical chemistry, hematology, or urinalysis were conducted and no organ weights were taken. Extra investigation on copper content in liver and kidneys included.
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- - Analytical purity: The chemical analysis, performed at Midwest Research Institute indicated that the purity was 104.7 % +- 1.1 % (elemental analysis)
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries
- Weight at study initiation: males: 72 - 94 g; females: 70 - 90 g
- Housing: polycarbonate cages: groups of 5 rats per cage
- Diet: weighed portions of Purina Lab Chow in meal form, mixed together with weighed portions of the test material (see details at "doses/concentrations")
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 40 - 60 %
- Air changes: at least 15 per hour
- Photoperiod: 12 hrs dark / 12 hrs light - Route of administration:
- oral: feed
- Vehicle:
- other: 12 % water was added to the test material as a dust control agent
- Details on oral exposure:
- Dose levels of 5.0, 2.5, 1.25, 0.6 and 0.3 % (w/w) were selected for both males and females. The selected doses were prepared by mixing weighed portions of purina Lab Chow in meal form with weighed portions of the test material. 12 % water was added to the test material as a dust control agent prior to mixing with the meal. For each dose level, one weekly lot of 4500 g (+ 12 % water compensation) was prepared.
The actual mixtures were composed of the following ingredients:
- Dose level 5.0 % (w/w): 252 g test material and water + 4275 g meal
- Dose level 2.5 % (w/w): 126 g test material and water + 4387.5 g meal
- Dose level 1.25 % (w/w): 63 g test material and water + 4443.75 g meal
- Dose level 0.6 % (w/w): 30.24 g test material and water + 44735 g meal
- Dose level 0.3 % (w/w): 15.12 g test material and water + 4486.5 g meal
Each diet was mixed in a Patterson-Kelly twin shelled V blender for 15 min.
The doses were mixed one or two days prior to the week of their use in the study, and stored at 23 °C.
One analysis was perfomed to determine the accuracy of the mixture concentration. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- One analysis was performed to determine the accuracy of mixture concentrations; results were within +/- 10 % of the desired dose concentration.
- Duration of treatment / exposure:
- 91 days
- Frequency of treatment:
- daily
- Dose / conc.:
- 0.3 other: % in the diet
- Dose / conc.:
- 0.6 other: % in the diet
- Dose / conc.:
- 1.25 other: % in the diet
- Dose / conc.:
- 2.5 other: % in the diet
- Dose / conc.:
- 5 other: % in the diet
- No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- yes, plain diet
- Details on study design:
- - Five dose levels of 0.0, 0.3, 0.6, 1.25, 2.5 and 5.0 % in feed were used in this study (approx. 0, 250, 500, 1100, 2200 and 4500 mg/kg bw for both sexes [based on 16.4 g/d average food consumption, 0.182 kg average bw for males and on 11.55 g/d average food consumption, 0.130 kg average bw] for females).
- The selected doses were prepared by mixing together weighed portions of Purina Lab Chow in meal form with weighed portions of the chemical. 12 % water was added to the chemical as a dust control agent prior to mixing with the meal.
- Each dosed group received 91 consecutive days of dosed feed mixture. - Observations and examinations performed and frequency:
- Animals were observed twice each day for clinical signs, with at least six hours between observations. All clinical signs were recorded daily. Additional studies included blood sampling for the animal disease screening program from 10 control rats, 5 males and 5 females.
- Sacrifice and pathology:
- - Rats were necropsied on day 92 and 93.
- Gross examination were performed on all animals from all dosage groups.
- Microscopic examinations were performed on all tissues from all animals in the control group and the highest dose treatment group: Kidney, liver, lung, heart, pancreas and pituitary. - Other examinations:
- Copper analyses were completed in the liver and kidney tissues and the formalin preserving those tissues from male rats in the highest dose group (5 % w/w) and control groups. See details and results in endpoint "7.1.1. Basic toxicokinetics" in endpoint study record "Batelle 76-34-106002, rat".
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The body weight data showed differential weight gains in dosed rats no greater than 10 % to the control group; except in the highest dose level females which had + 12 % differential gain. However, no trend was established through the groups in either males or females. The greatest range between any two female groups was 12 % to - 5 % between the two highest doses (5 % and 2 .5 %). The greatest range between any two male groups was 9 % to -9 % between the highest dose and the third highest dose (5 % and 1 .25 %).
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Microscopically the observed lesions were encountered in both the control and experimental high dose group with similar frequency and severity . The high incidence of pulmonary lesions in both groups is thought to be associated with Sendai virus infection. No histopathologic lesions considered to be compound-related were encountered in the tissues examined.
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 4 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse findings
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- No accumulation of copper in liver or kidneys
- Critical effects observed:
- no
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
- Reference Type:
- other: expert judgement
- Title:
- Phthalocyanine Blue 15 B and Phthalocyanine Green 7
- Author:
- Mennear JH
- Year:
- 1 980
- Bibliographic source:
- Assessment from Dr. Mennear JH, Expert Toxicologist to Dr. Moore JA, Deputy Director NTP
- Report date:
- 1980
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study examined, whether or not systemic absorption of copper occured after 90-day high dose feed exposure to the test material. Copper analyses were conducted in livers and kidneys of the animals.
- GLP compliance:
- no
Test material
- Reference substance name:
- 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
- EC Number:
- 205-685-1
- EC Name:
- 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
- Cas Number:
- 147-14-8
- Molecular formula:
- C32H16CuN8
- IUPAC Name:
- [29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: The chemical analysis, performed at Midwest Research Institute indicated that the purity was 104.7 % +- 1.1 % (elemental analysis)
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries
- Weight at study initiation: males: 70 - 105 g; females: 70 - 100 g
- Housing: polycarbonate cages: groups of 5 rats per cage
- Diet: weighed portions of Purina Lab Chow in meal form, mixed together with weighed portions of the test material (see details at "doses/concentrations")
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 40 - 60 %
- Air changes: at least 15 per hour
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: 12 % water was added to the test material as a dust control agent
- Details on exposure:
- Dose levels of 5.0, 2.5, 1.25, 0.6 and 0.3 % (w/w) were selected for both males and females. The selected doses were prepared by mixing weighed portions of purina Lab Chow in meal form with weighed portions of the test material. 12 % water was added to the test material as a dust control agent prior to mixing with the meal. For each dose level, one weekly lot of 4500 g (+ 12 % water compensation) was prepared.
The actual mixtures were composed of the following ingredients:
- Dose level 5.0 % (w/w): 252 g test material and water + 4275 g meal
- Dose level 2.5 % (w/w): 126 g test material and water + 4387.5 g meal
- Dose level 1.25 % (w/w): 63 g test material and water + 4443.75 g meal
- Dose level 0.6 % (w/w): 30.24 g test material and water + 44735 g meal
- Dose level 0.3 % (w/w): 15.12 g test material and water + 4486.5 g meal
Each diet was mixed in a Patterson-Kelly twin shelled V blender for 15 min.
The doses were mixed one or two days prior to the week of their use in the study, and stored at 23 °C.
One analysis was perfomed to determine the accuracy of the mixture concentration. - Duration and frequency of treatment / exposure:
- 90 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.3 other: % in the diet
- Dose / conc.:
- 0.6 other: % in the diet
- Dose / conc.:
- 1.25 other: % in the diet
- Dose / conc.:
- 2.5 other: % in the diet
- Dose / conc.:
- 5 other: % in the diet
- No. of animals per sex per dose / concentration:
- 10 males per dose and 10 females per dose
- Control animals:
- yes, plain diet
- Details on study design:
- The concentrations of the chemical mixture were the same for male and female rats. All dose levels were prepared on a weight per weight basis. There were 5 dose level groups with 10 individuals of each sex in each dosage and control group. Each dosed group received 90 consecutive days of dosed feed mixture. After one day of observation, the animals were necropsied. Animals were observed twice each day for clinical signs, with at least 6 hours between observations. All observations were recorded daily. Additionally, blood sampling was conducted from 10 control rats, 6 males and 4 females.
Copper analyses were completed in the liver and kidney tissues and the formalin preserving those tissues from male rats in the highest dose group (5 % w/w) and control groups:
- Tissue samples were prepared for analysis by digesting in 10 ml of concentrated nitric acid until most of the organic material was destroyed. Perchloric acid was then added and the solutions were evaporated to strong fumes, additional nitric acid being added as required. The solutions were then fumed to dryness, the residues were dissolved in 5 % nitric acid and the solutions were diluted to 10 ml.
- Formalin samples were filtered through a Millex-GS 0.22 µm filter unit and 5 ml portions of each sample were prepared for analysis by the procedure used to prepare the tissue samples.
- The samples were then subjected to atomic absorption spectrophotometry to determine copper content:
A Perkin-Elmer Model 5000 atomic absorption spectrophotometer was utilized for the work. A series of 10 ml standard solutions, ranging from 0.05 to 2.0 ppm were prepared in 5 % nitric acid by dilution of a certified standard copper stock solution. These solutions were used to calibrate the instrument, which was programmed to print out data as total microgramms of copper per sample. The prepared sample solutions were used in the same manner as the standards. Concentrations of copper in the tissue samples were calculated by dividing the total microgramms found by the weight of the sample. Concentrations of copper in the formalin samples were calculated on a volume basis. - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (distribution)
- Tissues and body fluids sampled: liver and kidneys - Statistics:
- Student´s T-test (alpha = 0.05) was used to compare the highest dose group results with control results.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- No data given.
- Details on distribution in tissues:
- No statistically significant increase of residual copper incorporation was neither reported for the liver tissues (2.82 ppm +- 0.34 ppm) nor for the kidney tissues (5.62 ppm +- 0.49 ppm) of the treated male rats of the highest dose group, compared to residual copper incorporation found in controls (liver 2.78 ppm +- 0.51 ppm; kidney 5.30 ppm +- 0.83 ppm). From all the formalin analyses performed, the authors drawed the conclusion that no detectable levels of copper were leached from the preserved tissue into the formalin bath.
- Details on excretion:
- No data given.
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- No data given.
Any other information on results incl. tables
Table 1: Copper determinations in tissues and formalin of male rats from the subchronic study, treated with the test material for 90 days
male animal # |
ppm copper |
|
||
|
liver |
kidney |
formalin |
remark |
highest dose group (5 % w/w) |
|
|
|
|
1 |
4.6 - 4.3* |
8.4 |
0.1 |
* results of 2 analyses |
2 |
5.9 |
12.3 |
0.1 |
|
3 |
4.1 - 4.4* |
8.6 - 10.1* |
0.1 |
* results of 2 analyses |
4 |
6.4 |
7.7 |
0.1 |
|
5 |
3.2 |
6.7 |
0.1 |
|
6 |
3.5 |
5.8 |
0.1 |
|
7 |
3.7 |
8.1 |
0.1 |
|
8 |
3.5 - 4.1 |
8.1 |
0.1 |
|
9 |
3.1 |
8.7 - 8.6* |
0.1 |
* results of 2 analyses |
10 |
4.6 - 4.5 |
7.2 |
0.1 |
|
control |
|
|
|
|
1 |
3.1 |
3.7 - 4.0* |
0.1 |
* results of 2 analyses |
2 |
3.3 |
4.1 |
0.1 |
|
3 |
3.2 |
4.9 - 4.6* |
0.1 |
* results of 2 analyses |
4 |
3.7 - 4.0* |
5.1 |
0.1 |
* results of 2 analyses |
5 |
3.0 |
4.1 |
0.1 |
|
6 |
2.8 |
5.4 |
0.1 |
|
7 |
2.9 |
2.9 - 3.4* |
0.1 |
* results of 2 analyses |
8 |
2.6 |
5.5 |
0.1 |
|
9 |
2.6 |
5.4 |
0.1 |
|
10 |
3.3 - 3.6* |
5.4 |
0.1 |
* results of 2 analyses |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.