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EC number: 270-099-5 | CAS number: 68411-06-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2014-2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 14-day gavage study with clinical chemistry, haematology, some organ weights and examination of plasma and liver concentrations of copper
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- [[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper
- EC Number:
- 261-638-5
- EC Name:
- [[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper
- Cas Number:
- 59160-79-1
- Molecular formula:
- C59 H31 Cu N11 O6
- IUPAC Name:
- [[2,2',2''-[(29H,31H-phthalocyanine-C,C,C-triyl-kN29,kN30,kN31,kN32)tris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)]-copper
- Test material form:
- solid: nanoform
- Details on test material:
- BET: 17.5 m2/g
TEM (min. Feret): 46.2 nm (D50)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: 42 +/- 1 days
- Weight at study initiation:
- Fasting period before study: none
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2014-06-09 To:2014-06-24
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: drinkmg water containing 0.5% carboxymethylcellulose with about 5 mg/100 ml Cremophor EL
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Daily
The substance is a homogenous suspension. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Data on structurally related copper phthalocyanines
- Rationale for animal assignment (if not random): on the basis of the animal weight.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 3, 7 and 14.
Food consumption and water consumption were determined on study days 3, 7 and 14.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 14
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: all
- Parameters listed below were examined:
1. Leukocytes
2. Erythrocytes
3. Hemoglobin
4. Hematocrit
5. Mean corpuscular volume (MCV)
6. Mean corpuscular hemoglobin (MCH)
7. Mean corpuscular hemoglobin concentration (MCHC)
8. Platelets
9. Differential blood count
10. Reticulocytes
11 . Preparation of blood smears (on ly evaluated blood smears will be archived)
12. Prothrombin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 14
- Animals fasted: Yes
- How many animals: all
- Parameters listed below were examined.
1. Alanine aminotransferase
2. Aspartate aminotransferase
3. Alkaline phosphatase
4. Serum -glutamyl transferase
5. Sodium
6. Potassium
7. Chloride
8. lnorg. phosphate
9. Calcium
10. Urea
11 . Creatinine
12. Glucose
13. Total bilirubin
14. Totalprotein
15. Albumin
16. Globulins
17. Triglycerides
18. Cholesterol
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: The determination of copper concentrations in EDTA plasma samples after were performed at the test facility.
The total concentrations of the test substance in plasma were calculated indirectly from the determined copper concentrations (inductively-coupled-plasma mass-spectrometry; experimental error + /- 0,2 mg/kg Cu).
This part of the study was carried out in compliance with the Principles of Good Laboratory Practice.
On study day 15 EDTA blood samples (about 200 μL) were collected from fasted animals by puncturing the retro-bulbar venous plexus under isoflurane anesthesia. After plasma preparation, the samples were frozen at about -80°C prior to analysis.
Half of the liver tissue (divided in two parts) of all animals were deep frozen for each animal and stored at -80°C for the determination of the test substance by the analytical chemistry. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ Weights:
Adrenal glands, Kidneys, Liver, Spleen
HISTOPATHOLOGY: Yes (all gross lesion, Adrenal glands, Kidneys, Liver, Spleen) - Statistics:
- Food consumption, water consumption, body weight, body weight change: , Dunnett test (two-sided)
Clinical pathology parameters, organ weights and body weights of anesthetized animals: KRUSKAL-WALLIS and WILCOXON
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- No animal died prematurely in the present study.
No test substance-related, adverse findings were observed. During the administration period, discolored feces were observed in all animals of test group 1 and 2 (300 and 1000 mg/kg bw/d). These findings were clearly related to the color of the test substance and assessed as being non-adverse.
The discoloration of intestinal content (stomach, jejunum, colon) in treated animals was related to the color of test substance. No discoloration of organs was observed.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No indication of systemic uptake from plasma and liver copper levels. No adverse effects on haematology, clinical chemistry, body weights, organ weights.
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Red blood cell and coagulation parameters (males)
control | 300 mg/kg bw | 1000 mg/kd bw | ||
RBC | Mean | 7.68 k | 7.60 | 7.73 |
[tera/L] | S.d. | 0.18 | 0.20 | 0.47 |
N | 5 | 5 | 5 | |
Median | 7.69 | 7.50 | 7.75 | |
HGB | Mean | 8.6 k | 8.5 | 8.7 |
[mmol/L] | S.d. | 0.2 | 0.3 | 0.4 |
N | 5 | 5 | 5 | |
Median | 8.6 | 8.7 | 8.8 | |
HCT | Mean | 0.420 k | 0.416 | 0.424 |
[L/L] | S.d. | 0.008 | 0.009 | 0.016 |
N | 5 | 5 | 5 | |
Median | 0.418 | 0.418 | 0.423 | |
MCV | Mean | 54.7 k | 54.7 | 55.0 |
[fL] | S.d. | 1.1 | 1.5 | 2.1 |
N | 5 | 5 | 5 | |
Median | 54.6 | 53.7 | 54.7 | |
MCH | Mean | 1.12 k | 1.12 | 1.13 |
[fmol] | S.d. | 0.02 | 0.04 | 0.03 |
N | 5 | 5 | 5 | |
Median | 1.13 | 1.11 | 1.13 | |
MCHC | Mean | 20.47 k | 20.52 | 20.55 |
[mmol/L] | S.d. | 0.11 | 0.32 | 0.34 |
N | 5 | 5 | 5 | |
Median | 20.46 | 20.56 | 20.68 | |
RET | Mean | 2.8 k | 2.6 | 2.5 |
[%] | S.d. | 0.5 | 0.5 | 0.6 |
N | 5 | 5 | 5 | |
Median | 2.8 | 2.7 | 2.5 | |
PLT | Mean | 818 k | 877 | 708 |
[giga/L] | S.d. | 110 | 89 | 99 |
N | 5 | 5 | 5 | |
Median | 774 | 911 | 703 | |
HQT | Mean | 36.7 k | 38.8 | 38.5 |
[sec] | S.d. | 0.9 | 1.9 | 1.4 |
N | 5 | 5 | 5 | |
Median | 36.6 | 37.4 | 38.3 |
Red blood cell and coagulation parameters (females)
control | 300 mg/kg bw | 1000 mg/kd bw | ||
RBC | Mean | 7.83 k | 7.61 | 7.73 |
[tera/L] | S.d. | 0.30 | 0.19 | 0.13 |
N | 5 | 5 | 5 | |
Median | 7.67 | 7.59 | 7.81 | |
HGB | Mean | 8.5 k | 8.4 | 8.6 |
[mmol/L] | S.d. | 0.2 | 0.2 | 0.2 |
N | 5 | 5 | 5 | |
Median | 8.5 | 8.4 | 8.6 | |
HCT | Mean | 0.405 k | 0.398 | 0.406 |
[L/L] | S.d. | 0.011 | 0.009 | 0.012 |
N | 5 | 5 | 5 | |
Median | 0.398 | 0.401 | 0.412 | |
MCV | Mean | 51.8 k | 52.2 | 52.5 |
[fL] | S.d. | 2.1 | 0.9 | 1.1 |
N | 5 | 5 | 5 | |
Median | 52.2 | 52.1 | 52.9 | |
MCH | Mean | 1.09 k | 1.10 | 1.11 |
[fmol] | S.d. | 0.04 | 0.02 | 0.02 |
N | 5 | 5 | 5 | |
Median | 1.10 | 1.09 | 1.12 | |
MCHC | Mean | 21.09 k | 21.08 | 21.16 |
[mmol/L] | S.d. | 0.24 | 0.11 | 0.27 |
N | 5 | 5 | 5 | |
Median | 20.99 | 21.08 | 21.23 | |
RET | Mean | 1.7 k | 1.8 | 1.6 |
[%] | S.d. | 0.2 | 0.4 | 0.5 |
N | 5 | 5 | 5 | |
Median | 1.8 | 1.6 | 1.7 | |
PLT | Mean | 828 k | 839 | 756 |
[giga/L] | S.d. | 70 | 101 | 83 |
N | 5 | 5 | 5 | |
Median | 846 | 801 | 770 | |
HQT | Mean | 35.1 k | 35.1 | 35.9 |
[sec] | S.d. | 2.1 | 1.5 | 1.4 |
N | 5 | 5 | 5 | |
Median | 36.4 | 35.2 | 35.3 |
Total white and differential blood cell count (males)
control | 300 mg/kg bw | 1000 mg/kd bw | ||
WBC | Mean | 5.57 k | 5.62 | 5.36 |
[giga/L] | S.d. | 0.96 | 1.75 | 1.98 |
N | 5 | 5 | 5 | |
Median | 5.63 | 5.21 | 5.26 | |
NEUTA | Mean | 0.61 k | 0.70 | 0.93 |
[giga/L] | S.d. | 0.16 | 0.32 | 0.23 |
N | 5 | 5 | 5 | |
Median | 0.64 | 0.65 | 0.93 | |
LYMPHA | Mean | 4.73 k | 4.72 | 4.16 |
[giga/L] | S.d. | 0.84 | 1.53 | 1.72 |
N | 5 | 5 | 5 | |
Median | 4.72 | 4.30 | 4.29 | |
MONOA | Mean | 0.12 k | 0.10 | 0.10 |
[giga/L] | S.d. | 0.03 | 0.03 | 0.06 |
N | 5 | 5 | 5 | |
Median | 0.11 | 0.09 | 0.08 | |
EOSA | Mean | 0.06 k | 0.06 | 0.14 |
[giga/L] | S.d. | 0.02 | 0.03 | 0.09 |
N | 5 | 5 | 5 | |
Median | 0.06 | 0.05 | 0.09 | |
BASOA | Mean | 0.01 k | 0.01 | 0.01 |
[giga/L] | S.d. | 0.01 | 0.00 | 0.01 |
N | 5 | 5 | 5 | |
Median | 0.01 | 0.01 | 0.01 | |
LUCA | Mean | 0.03 k | 0.03 | 0.03 |
[giga/L] | S.d. | 0.02 | 0.01 | 0.01 |
N | 5 | 5 | 5 | |
Median | 0.03 | 0.03 | 0.02 | |
NEUT | Mean | 11.0 v | 12.6 | 18.3 ** |
[%] | S.d. | 2.2 | 3.9 | 4.4 |
N | 5 | 5 | 5 | |
Median | 10.9 | 13.6 | 15.6 | |
LYMPH | Mean | 84.9 v | 83.8 | 76.4 * |
[%] | S.d. | 2.3 | 4.3 | 5.8 |
N | 5 | 5 | 5 | |
Median | 86.2 | 82.6 | 79.3 | |
MONO | Mean | 2.1 k | 1.7 | 1.8 |
[%] | S.d. | 0.6 | 0.3 | 0.8 |
N | 5 | 5 | 5 | |
Median | 2.1 | 1.7 | 1.6 | |
EOS | Mean | 1.2 k | 1.1 | 2.7 |
[% ] | S.d. | 0.4 | 0.3 | 1.9 |
N | 5 | 5 | 5 | |
Median | 1.0 | 1.1 | 1.7 | |
BASO | Mean | 0.3 k | 0.2 | 0.3 |
[%] | S.d. | 0.1 | 0.1 | 0.1 |
N | 5 | 5 | 5 | |
Median | 0.2 | 0.2 | 0.2 | |
LUC | Mean | 0.6 k | 0.6 | 0.5 |
[%] | S.d. | 0.2 | 0.1 | 0.2 |
N | 5 | 5 | 5 | |
Median | 0.6 | 0.6 | 0.6 |
Total white and differential blood cell count (females)
control | 300 mg/kg bw | 1000 mg/kd bw | ||
WBC | Mean | 4.53 k | 4.29 | 4.49 |
[giga/L] | S.d. | 0.72 | 0.91 | 1.74 |
N | 5 | 5 | 5 | |
Median | 4.51 | 4.45 | 3.59 | |
NEUTA | Mean | 0.38 k | 0.47 | 0.55 |
[giga/L] | S.d. | 0.03 | 0.15 | 0.15 |
N | 5 | 5 | 5 | |
Median | 0.39 | 0.38 | 0.50 | |
LYMPHA | Mean | 3.98 k | 3.67 | 3.78 |
[giga/L] | S.d. | 0.68 | 1.00 | 1.53 |
N | 5 | 5 | 5 | |
Median | 3.96 | 3.94 | 3.04 | |
MONOA | Mean | 0.08 k | 0.06 | 0.07 |
[giga/L] | S.d. | 0.03 | 0.02 | 0.05 |
N | 5 | 5 | 5 | |
Median | 0.08 | 0.05 | 0.06 | |
EOSA | Mean | 0.07 k | 0.05 | 0.06 |
[giga/L] | S.d. | 0.02 | 0.01 | 0.05 |
N | 5 | 5 | 5 | |
Median | 0.07 | 0.05 | 0.05 | |
BASOA | Mean | 0.01 k | 0.01 | 0.01 |
[giga/L] | S.d. | 0.00 | 0.01 | 0.01 |
N | 5 | 5 | 5 | |
Median | 0.01 | 0.01 | 0.01 | |
LUCA | Mean | 0.02 k | 0.03 | 0.02 |
[giga/L] | S.d. | 0.00 | 0.01 | 0.01 |
N | 5 | 5 | 5 | |
Median | 0.02 | 0.03 | 0.01 | |
NEUT | Mean | 8.5 k | 11.7 | 13.1 |
[%] | S.d. | 1.4 | 5.6 | 3.3 |
N | 5 | 5 | 5 | |
Median | 8.2 | 8.5 | 11.8 | |
LYMPH | Mean | 87.7 k | 84.7 | 83.6 |
[%] | S.d. | 1.1 | 5.8 | 3.2 |
N | 5 | 5 | 5 | |
Median | 87.8 | 87.5 | 84.0 | |
MONO | Mean | 1.6 k | 1.5 | 1.5 |
[%] | S.d. | 0.5 | 0.3 | 0.5 |
N | 5 | 5 | 5 | |
Median | 1.6 | 1.4 | 1.6 | |
EOS | Mean | 1.4 k | 1.1 | 1.2 |
[%] | S.d. | 0.1 | 0.1 | 0.4 |
N | 5 | 5 | 5 | |
Median | 1.4 | 1.2 | 1.1 | |
BASO | Mean | 0.3 k | 0.3 | 0.2 |
[%] | S.d. | 0.1 | 0.1 | 0.1 |
N | 5 | 5 | 5 | |
Median | 0.2 | 0.3 | 0.3 | |
LUC | Mean | 0.5 v | 0.6 | 0.4 |
[%] | S.d. | 0.2 | 0.1 | 0.1 |
N | 5 | 5 | 5 | |
Median | 0.5 | 0.6 | 0.4 |
Enzymes (males)
control | 300 mg/kg bw | 1000 mg/kd bw | ||
ALT | Mean | 0.85 k | 0.87 | 0.87 |
[µkat/L] | S.d. | 0.20 | 0.07 | 0.14 |
N | 5 | 5 | 5 | |
Median | 0.84 | 0.82 | 0.86 | |
AST | Mean | 1.66 k | 1.67 | 1.70 |
[µkat/L] | S.d. | 0.16 | 0.36 | 0.29 |
N | 5 | 5 | 5 | |
Median | 1.68 | 1.56 | 1.71 | |
ALP | Mean | 2.50 k | 2.92 | 2.65 |
[µkat/L] | S.d. | 0.11 | 0.55 | 0.55 |
N | 5 | 5 | 5 | |
Median | 2.52 | 2.76 | 2.38 | |
GGT_C | Mean | 0 | 0 | 0 |
[nkat/L] | S.d. | 0 | 0 | 0 |
N | 5 | 5 | 5 | |
Median | 0 | 0 | 0 |
Enzymes (females)
control | 300 mg/kg bw | 1000 mg/kd bw | ||
ALT | Mean | 0.60 k | 0.71 | 0.67 |
[µkat/L] | S.d. | 0.10 | 0.13 | 0.18 |
N | 5 | 5 | 5 | |
Median | 0.56 | 0.64 | 0.67 | |
AST | Mean | 1.52 k | 1.62 | 1.69 |
[µkat/L] | S.d. | 0.06 | 0.18 | 0.23 |
N | 5 | 5 | 5 | |
Median | 1.51 | 1.56 | 1.58 | |
ALP | Mean | 1.54 k | 2.18 | 2.09 |
[µkat/L] | S.d. | 0.43 | 0.89 | 0.66 |
N | 5 | 5 | 5 | |
Median | 1.73 | 1.75 | 2.28 | |
GGT_C | Mean | 0 | 0 | 0 |
[nkat/L] | S.d. | 0 | 0 | 0 |
N | 5 | 5 | 5 | |
Median | 0 | 0 | 0 |
Applicant's summary and conclusion
- Conclusions:
- There is no indication of systemic uptake after ingestion based on the absence of findings and the absence of elevated copper concentrations in plasma after 14 days of exposure.
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