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EC number: 215-524-7 | CAS number: 1328-53-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 74260.
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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:
- comparable to guideline study with acceptable restrictions
- Objective of study:
- distribution
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Determination of copper content in liver and kidney at the end of a 90 day feeding study with up to 5% in the diet.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Analytical purity: 97.8 %
- Radiolabelling:
- no
- 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 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- 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. For each dose level, one weekly lot of 4500 g was prepared.
The actual mixtures were composed of the following ingredients:
- Dose level 5.0 % (w/w): 225 g test material and water + 4275 g meal
- Dose level 2.5 % (w/w): 112.5 g test material and water + 4387.5 g meal
- Dose level 1.25 % (w/w): 56.25 g test material and water + 4443.75 g meal
- Dose level 0.6 % (w/w): 27 g test material and water + 44735 g meal
- Dose level 0.3 % (w/w): 13.5 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
- Dose / conc.:
- 0.3 other: % in the diet
- Remarks:
- ca 300 mg/kg bw
- 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
- 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, 5 males and 5 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.
- Type:
- absorption
- Results:
- No systemic uptake after ingestion
- Details on distribution in tissues:
- Copper content of liver: 4.28 +/- 1.1 (Test group) and 3.08 +/- 0.39 ppm (control group)
Copper content of kidney: 8.23 +/- 1.75 (Test group) and 4.68 +/- 0.82 ppm (control group).
An evaluation of these results led the authors to the conclusion, that it is unlikely that the test material was appreciably resorbed from the gastrointestinal tract due to its insolubility and chemical inertness. It was rather suggested that free copper, present as minor impurity in the pigment was responsible for the slight increase in tissue copper levels that were noted.
From all the formalin analyses performed, the authors concluded that no detectable levels of copper were leached from the preserved tissue into the formalin bath. - Metabolites identified:
- no
- Details on metabolites:
- No data given.
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 |
* Results of 2 analyses |
9 |
3.1 |
8.7 - 8.6* |
< 0.1 |
* Results of 2 analyses |
10 |
4.6 - 4.5 |
7.2 |
< 0.1 |
* Results of 2 analyses |
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 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- 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 (as recommended in OECD Guideline 408). In accition, copper levels were determined in liver and kidneys
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Polychloro copper phthalocyanine
- EC Number:
- 215-524-7
- EC Name:
- Polychloro copper phthalocyanine
- Cas Number:
- 1328-53-6
- Molecular formula:
- C32HxClyCuN8
- IUPAC Name:
- [1,2,3,4,8,9,10,11,15,16,17,18,22,23,25-pentadecachloro-5,26-dihydro-29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: 97.8 %
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:
- unchanged (no vehicle)
- 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. For each dose level, one weekly lot of 4500 g was prepared.
The actual mixtures were composed of the following ingredients:
- Dose level 5.0 % (w/w): 225 g test material and water + 4275 g meal
- Dose level 2.5 % (w/w): 112.5 g test material and water + 4387.5 g meal
- Dose level 1.25 % (w/w): 56.25 g test material and water + 4443.75 g meal
- Dose level 0.6 % (w/w): 27 g test material and water + 44735 g meal
- Dose level 0.3 % (w/w): 13.5 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. - 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
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.3 other: % in the diet
- Dose / conc.:
- 0.6 other: % in the idiet
- 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 0.3, 0.6, 1.25, 2.5 and 5.0 % in feed were used in this study (approx. 300, 600, 1200, 2300 and 4600 mg/kg bw for males [based on 15.4 g/d average food consumption, 0.167 kg average bw] and approx. 300, 600, 1250, 2500 and 5000 mg/kg bw for females [based on 12.3 g/d average food consumption, 0.123 kg average bw], respectively).
- All dose levels were prepared on a weight per weight basis. There were five dose level groups and one group of controls per sex, with ten individuals of each sex in each dosage and control group. Each dosed group received dosed feed mixture on 91 consecutive days. - Positive control:
- not required
Examinations
- 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 ten control rats, five males and five 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, testis, epididymis, prostate, stomach, thyroid, skin, cecum, pancreas and spleen. - Other examinations:
- Copper analyses were completed in the liver and kidney tissues and the formalin preserving those tissues from male mice in the highest dose group (5 % w/w) and control groups. See details and results in endpoint "7.1.1. Basic toxicokinetics".
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- There were dose-related trends in body weights among both male and female rats, when body weights are expressed in percent differentials of weight gains compared with untreated controls. Male rats at the highest doses of 5.0 % and 2.5 % had differential weight gains of -11 % and -5 % respectively. Female rats at the top doses of 5.0 and 2.5 % had differential weight gains of -9.0 %. These changes in dosed group body weights are not severe and may not be a meaningful sign of toxicity.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- There were slight trends in patterns of diet consumption between dosed and control rats of both sexes, with dosage groups eating about 1 g more of the higher concentrations of the dosed feed. This may be an adjustment in diet intake to offset the relatively high portion of non-caloric dyestuff present in the diet. Daily average diet consumption for female rats ranged from 11.5 g (controls) to as much as 12.7 g (1.25 %); for male rats, the range was from 14.6 g (controls) to 16.6 g (2.5 %).
- 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:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Details on results:
- The authors recommended an dosage level of 5 % and 2.5 % test substance to be used in the chronic study, due to lack of compound-related lesions.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 4 600 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no adverse findings
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 5 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no adverse findings
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
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