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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2014-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
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
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 from rats induced with phenobarbital i.p. and β-naphthoflavone orally
- Test concentrations with justification for top dose:
- 1st Experiment
4-hour exposure, 18-hour sampling time, with and without S9 mix
0; 3.13; 6.25; 12.5; 25; 50 μg/mL
2nd Experiment
18-hour exposure, 18-hour sampling time, without S9 mix
0; 1.56; 3.13; 6.25; 12.5; 25; 50 μg/mL
18-hour exposure, 28-hour sampling time, without S9 mix
0; 1.56; 3.13; 6.25; 12.5; 25; 50 μg/mL
4-hour exposure, 28-hour sampling time, with S9 mix
0; 1.56; 3.13; 6.25; 12.5; 25; 50 μg/mL - Vehicle / solvent:
- Acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 24 - 30 hours
- Exposure duration: 4h or 18h
- Expression time (cells in growth medium): 10, 14 or 24 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 28h
SPINDLE INHIBITOR (cytogenetic assays): colcemide
STAIN (for cytogenetic assays): 7.5% (v/v) Giemsa/Titrisol solution pH 7.2
NUMBER OF REPLICATIONS:2
NUMBER OF CELLS EVALUATED: 100 metaphases per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- The V79 in vitro cytogenetic assay is considered valid if the following criteria are met:
• The quality of the slides must allow the identification and evaluation of a sufficient number of analyzable metaphases.
• The numbers of cells with structural/numerical aberrations in the negative control has to be within the range of the historical negative control data.
• The positive control substances both with and without S9 mix have to induce a distinct increase of structural chromosome aberrations.
The test substance is considered as “positive” if the following criteria are met:
• A statistically significant, dose-related and reproducible increase in the number of cells
with structural chromosome aberrations (excl. gaps).
• The number of aberrant cells (excl. gaps) exceeds both the concurrent negative/vehicle
control value and the historical negative control data range.
A test substance generally is considered as “negative” if the following criteria are met:
• The number of cells with structural aberrations (excl. gaps) in the dose groups is not
statistically significant increased above the concurrent negative/vehicle control value and
is within the historical negative control data range. - Statistics:
- The statistical evaluation of the data was carried out using the MUCHAN program system (BASF SE). The proportion of metaphases with structural aberrations was calculated for each group. A comparison of each dose group with the negative control group was carried out using Fisher's exact test for the hypothesis of equal proportions. This test was Bonferroni- Holm corrected versus the dose groups separately for each time and was performed one-sided. If the results of this test are statistically significant compared with the respective vehicle control, labels (* p ≤ 0.05, ** p ≤ 0.01) are printed in the tables.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: none
- Evaporation from medium: not relevant
- Water solubility: poorly soluble
- Precipitation:yes - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Aberrant cells [%] | Cytotoxicity* | ||||||||
Test groups | S9 mix | Precipitation | incl. gaps# | excl. gaps# | with exchanges | Polyploid cells [%] | Cell number [%] | Mitotic index [%] | |
4/18 hrs | Vehicle control (Acetone) | - | n.d. | 8.0 | 4.0 | 0.5 | 0.0 | 100.0 | 100.0 |
3.13 µg/mL | - | - | n.d. | n.d. | n.d. | n.d. | 101.8 | n.d. | |
6.25 µg/mL | - | - | 5.5 | 2.5 | 0.5 | 0.0 | 117.9 | 101.2 | |
12.50 µg/mL | - | - | 4.0 | 3.0 | 1.0 | 0.0 | 113.9 | 100.0 | |
25.00 µg/mL | - | - | 3.0 | 2.5 | 1.0 | 1.0 | 110.0 | 99.2 | |
50.00 µg/mL | - | + | n.s. | n.s. | n.s. | n.s. | 112.9 | n.s. | |
100.00 µg/mL | - | + | n.s. | n.s. | n.s. | n.s. | 98.9 | n.s. | |
EMS 500 μg/mL | - | n.d. | 26.0s | 24.0s | 13.0s | 0.0 | n.t. | 89.4 | |
18/18 hrs | Vehicle control (Acetone) | - | n.d. | 2.0 | 1.5 | 0.5 | 0.0 | 100.0 | 100.0 |
1.56 µg/mL | - | - | n.d. | n.d. | n.d. | n.d. | 129.3 | n.d. | |
3.13 µg/mL | - | - | n.d. | n.d. | n.d. | n.d. | 115.9 | n.d. | |
6.25 µg/mL | - | - | 5.5 | 1.5 | 0.0 | 0.0 | 113.4 | 96.8 | |
12.50 µg/mL | - | - | 5.0 | 3.0 | 2.5 | 0.0 | 108.4 | 89.8 | |
25.00 µg/mL | - | + | 4.5 | 1.5 | 0.0 | 0.0 | 126.0 | 81.1 | |
50.00 µg/mL | - | + | n.s. | n.s. | n.s. | n.s. | 93.9 | n.s. | |
EMS 500 μg/mL | - | n.d. | 25.0s | 25.0s | 19.0s | 0.0 | n.t. | 61.4 | |
18/28 hrs | Vehicle control (Acetone) | - | n.d. | 4.5 | 1.5 | 0.5 | 0.0 | 100.0 | 100.0 |
1.56 µg/mL | - | - | n.d. | n.d. | n.d. | n.d. | 96.7 | n.d. | |
3.13 µg/mL | - | - | n.d. | n.d. | n.d. | n.d. | 92.0 | n.d. | |
6.25 µg/mL | - | - | n.d. | n.d. | n.d. | n.d. | 105.4 | n.d. | |
12.50 µg/mL | - | + | 3.5 | 1.0 | 0.5 | 0.0 | 111.8 | 121.8 | |
25.00 µg/mL | - | + | 6.5 | 3.0 | 2.0 | 0.0 | 113.6 | 120.3 | |
50.00 µg/mL | - | + | n.s. | n.s. | n.s. | n.s. | 94.6 | n.s. | |
EMS 500 μg/mL | - | n.d. | 34.0s | 31.0s | 23.0s | 0.0 | n.t. | 74.2 | |
4/18 hrs | Vehicle control (Acetone) | + | n.d. | 8.5 | 5.0 | 1.0 | 0.0 | 100.0 | 100.0 |
1.56 µg/mL | + | - | n.d. | n.d. | n.d. | n.d. | 96.0 | n.d. | |
3.13 µg/mL | + | - | n.d. | n.d. | n.d. | n.d. | 95.6 | n.d. | |
6.25 µg/mL | + | - | 4.5 | 3.0 | 1.0 | 0.0 | 104.4 | 143.9 | |
12.50 µg/mL | + | - | 4.5 | 1.5 | 1.0 | 0.0 | 87.9 | 127.5 | |
25.00 µg/mL | + | - | 5.0 | 2.5 | 0.5 | 1.0 | 81.9 | 116.4 | |
50.00 µg/mL | + | + | n.s. | n.s. | n.s. | n.s. | 62.8 | n.s. | |
CPP 0.5 μg/mL | + | n.d. | 27.0s | 27.0s | 19.0s | 0.0 | n.t. | 90.1 | |
4/28 hrs | Vehicle control (Acetone) | + | n.d. | 4.0 | 1.0 | 0.5 | 0.0 | 100.0 | 100.0 |
1.56 µg/mL | + | - | n.d. | n.d. | n.d. | n.d. | 91.2 | n.d. | |
3.13 µg/mL | + | - | 2.0 | 1.0 | 0.5 | 0.0 | 99.1 | 113.5 | |
6.25 µg/mL | + | - | 4.0 | 3.0 | 1.0 | 0.0 | 116.8 | 122.4 | |
12.50 µg/mL | + | - | 6.0 | 3.5 | 1.0 | 0.0 | 119.8 | 118.5 | |
25.00 µg/mL | + | + | n.s. | n.s. | n.s. | n.s. | 93.6 | n.s. | |
50.00 µg/mL | + | + | n.s. | n.s. | n.s. | n.s. | 113.2 | n.s. | |
CPP 0.5 μg/mL | + | n.d. | 26.0s | 23.0s | 12.0s | 0.0 | n.t. | 123.1 |
P Precipitation occured at the end of exposure period
* Relative values compared with the respective vehicle control
# Inclusive cells carrying exchanges
n.d. Not determined n.t. Not tested
n.s. Not scorable due to poor metaphase quality (precipitation)
S Aberration frequency statistically significant higher than corresponding control values
x Evaluation of a sample of 100 metaphase only due to strong clastogenicity
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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