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EC number: 235-476-0 | CAS number: 12239-87-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 26 September 2014
- Deviations:
- yes
- Remarks:
- No plasma analytics. Tested doses exceeded limit dose, 1000 cells per animal scored (but acceptable, since two groups above limit dose scored)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Impurities: in all likelihood solvents (nitrobenzene or chlorobenzene; concentration not known)
- Several batches were created from different raw material suppliers. These were tested in the Ames test to screen for quality of the raw materials
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TK 13 143 (crude copper phthalocyanine)
- Analytical purity: commercial grade
- Lot/batch No.: F 53 / H 91375
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: random outbred strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Tierfarm, Sisseln, Switzerland
- Age at study initiation: females 6 to 10 weeks, males 4 to 9 weeks
- Weight at study initiation: females 21 to 32 g, males 22 to 33 g in tolerability test; females 20 to 27 g, males 20 to 26 g in mutagenicity test
- Diet: NAFAG No. 924
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 23 °C
- Humidity: 40 - 46 %
- Housing in air conditioned rooms
- Photoperiod: 12hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5 % Carboxymethylcellulose (CMC), Hercules Comp., USA
- Details on exposure:
- Tolerability test:
A preliminary test was conducted to determine the highest dosage of the test material to be applied in the mutgenicity test (Doses / Concentrations:
200, 1000 and 5000 mg/kg bw). Three groups of 4 chinese hamsters were treated with 3 different single doses. The observation period corresponded to the interval between administration and sacrifice of the animals in the mutagenicity test, plus one day. The highest dose survived by all animals was used in the second part of the tolerability test.
In the second part, the animals were treated according to the scheme used in the mutagenicity test with consecutive doses. The observation period corresponded to the interval between administration and sacrifice of the animals in the mutagenicity test, plus one day. Depending on the outcome the highest dose causing no deaths was used as the highest in the mutagenicity test.
Mutagenicity test:
The test material was administered orally to groups of 6 female and 6 male animals each. Treatment consisted of daily one application on 2 consecutive days. 24 h after the second application the animals were sacrificed. - Duration of treatment / exposure:
- 48 h
- Frequency of treatment:
- two treatments on 2 consecutive days
- Post exposure period:
- 24 h after the second application
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Tolerability test: 2 animals per sex per dose
Mutagenicity test: 6 animals per sex per dose - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (ENDOXAN): 128 mg/kg bw in 20 ml/kg bw 0.5 % CMC
Examinations
- Details of tissue and slide preparation:
- Bone marrow was harvested from the shafts of both femurs and homogenized. Small drops were transferred on the end of a slide and spread out. 3 h later, the slides were stained in undiluted May-Grünwald solution/water for 2 min and in Giemsa´s 40 % for 20 min. After being rinsed in methanol 55 % for 5-8 sec and washed with water, the slides were cleaned in xylene and mounted in Eukitt.
The slides of three female and three male animals each of the negative and positive control group and of the groups treated with various doses of the test material were examined. 1000 bone marrow cells each were scored per animal and the following anomalies were registered: single jolly bodies, fragments of nuclei in erythrocytes, micronuclei in leucopoietic cells and polyploid cells. - Statistics:
- The significance of difference was assessed by x2-test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In all dose groups the percentage of cells displaying anomalies of nuclei did not differ significantly from the negative control (0.1 %).
By contrast, the positive control yielded in a marked increase of the percentage of cells with anomalies (9.48 %).
Any other information on results incl. tables
Table 1: Percent of cells with anomalies of nuclei
|
Animal No. |
Sex (m/f) |
Single Jolly Bodies |
Fragments of nuclei in erythrocytes |
Micronuclei in erythrocytes |
Micronuclei in leucopoietic cells |
Polyploid cells |
Total |
negative control |
1 |
f |
|
|
|
|
|
0.0 |
2 |
f |
0.2 |
|
|
|
|
0.2 |
|
3 |
f |
0.2 |
|
|
|
|
0.2 |
|
4 |
m |
0.1 |
|
|
|
|
0.1 |
|
5 |
m |
0.1 |
|
|
|
|
0.1 |
|
6 |
m |
|
|
|
|
|
0.0 |
|
cyclophosphamide |
1 |
f |
11.6 |
2.3 |
2.0 |
|
|
15.9 |
2 |
f |
4.5 |
1.0 |
1.6 |
0.1 |
|
7.2 |
|
3 |
f |
9.1 |
2.2 |
1.3 |
0.1 |
|
12.7 |
|
4 |
m |
6.7 |
0.7 |
1.0 |
0.3 |
0.3 |
9.0 |
|
5 |
m |
4.0 |
1.2 |
0.8 |
|
|
6.0 |
|
6 |
m |
4.4 |
0.6 |
0.9 |
0.2 |
|
6.1 |
|
1250 mg/kg bw |
1 |
f |
|
|
|
|
|
0.0 |
2 |
f |
|
|
|
|
|
0.0 |
|
3 |
f |
0.1 |
|
|
|
|
0.1 |
|
4 |
m |
|
|
|
|
|
0.0 |
|
5 |
m |
0.1 |
|
|
|
|
0.1 |
|
6 |
m |
0.1 |
|
|
|
|
0.1 |
|
2500 mg/kg bw |
1 |
f |
|
|
|
|
|
0.0 |
2 |
f |
0.2 |
|
|
|
|
0.2 |
|
3 |
f |
0.1 |
|
|
|
|
0.1 |
|
4 |
m |
0.3 |
|
|
|
|
0.3 |
|
5 |
m |
0.1 |
|
|
|
|
0.1 |
|
6 |
m |
|
|
|
|
|
0.0 |
|
5000 mg/kg bw |
1 |
f |
|
|
|
|
|
0.0 |
2 |
f |
0.2 |
|
|
|
|
0.2 |
|
3 |
f |
|
|
|
|
|
0.0 |
|
4 |
m |
0.1 |
|
|
|
|
0.1 |
|
5 |
m |
|
|
|
|
|
0.0 |
|
6 |
m |
0.1 |
|
|
|
|
0.1 |
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.
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