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EC number: 240-183-6 | CAS number: 16040-69-0
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study with the following restriction: Only 4 strains of bacteria (S. typhimurium TA1535, TA1537, TA100 and TA98) were tested, 5 strains are recommended in OECD guideline 471 (July 1997). No E. coli strain was tested.
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 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- ; the test substance was not tested in an additional E. coli strain or in S. typhimurium TA102, as recommended in the latest version of OECD guideline 471 (July 1997).
- Principles of method if other than guideline:
- The rate of induced back mutations was tested in the S. typhimurium indicator organisms TA1535, TA1537, TA98 and TA100. However, the mutagenic potential of the test substance was not tested in an additional E. coli strain or in S. typhimurium TA102, as recommended in the latest version of OECD guideline 471 (July 1997).
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
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
- IUPAC Name:
- [29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
- Details on test material:
- - Name of test material (as cited in study report): Heliogen Blau K 7080
- Analytical purity: ca. 98 %
- Impurities (identity and concentrations): no data given
- Storage condition of test material: 4 °C
Constituent 1
Method
- Target gene:
- Determination of the rate of induced back mutations of several bacteria mutants from histidine auxotrophy (his-) to histidine prototrophy (his+).
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from the liver of male Sprague-Dawley rats (treated with a single dose of 500 mg/kg bw Aroclor 1254 five days before sacrifice) and mixed with a series of cofactors (MgCl2, KCl, glucose-6-phosphate, NADP, phosphate buffer pH 7.4).
- Test concentrations with justification for top dose:
- - Standard plate test:
1st experiment:
0, 20, 100, 500, 2500 and 5000 µg/plate (tested in the strains S. typhimurium T98, TA100, TA1535 and TA1537), with and without metabolic activation.
2nd experiment:
0, 100, 500, 2500, 5000 and 10000 µg/plate (tested in the strains S. typhimurium T98, TA100, TA1535 and TA1537) with and without metabolic activation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see details on test system
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
A standard plate was conducted, with and without metabolic activation (S9-mix). Each test was conducted in triplicates.
STANDARD PLATE TEST:
The experimental procedure is based on the method of Ames et al. (Mut. Res. 31: 347-364, 1975):
Test tubes containing 2 ml portions of soft agar which consists of 100 ml agar (0.6 % agar + 0.6 % NaCl) and 10 ml amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at 45 °C and the remaining components are added in the following order:
0.1 ml test solution
0.1 ml bacterial suspension
0.5 ml S-9 mix (in tests with metabolic activation)
or
0.5 ml phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.
CONTROLS:
- Negative control:
Parallel with each experiment with and without S-9 mix, a negative control (solvent control with DMSO) is carried out for each tester strain in order to determine the spontaneous mutation rate.
- Positive controls:
The following positive control substances are used to check tIhe mutability of the bacteria and the activity of the S-9 mix:
with S-9 mix: 10 µg 2-aminoanthracene (dissolved in DMSO) for the strains TA 100, TA 98, TA 1537 and TA 1535.
without S-9 mix: 5 µg N-methyl-N´-nitro-N-nitrosoguanidine (MNNG) (dissolved in DMSO) for the strains TA 100 and TA 1535; 10 µg 4-nitro-o-phenylendiamine (dissolved in DMSO) for the strain TA 98; 100 µg 9-aminoacridine chloride monohydrate (dissolved in DMSO) for the strain TA 1537.
TITER DETERMINATION:
In general, the titer is determined only in the experiments with S-9 mix both without test substance (solvent only) and after adding the two highest doses of test substance. For this purpose, 0.1 ml of the overnight cultures is diluted to 1 x 10exp-6 in each case. Test tubes containing 2 ml portions of soft agar containing maximal amino acid solution (5 mM histidine + 0.5 mM biotin) are kept in a water bath at 45 °C, and the remaining components are added in the following order:
0.1 ml solvent (without and with test substance)
0.1 ml bacterial suspension (dilution: 1 x 10exp-6)
0.5 ml S-9 mix
After mixing, the samples are poured onto the Vogel-Bonner agar plates within approx. 30 seconds. After incubation at 37°C for 48 hours in the dark, the bacterial colonies are counted.
OTHER EXAMINATIONS:
The Salmonella strains are checked for the following characteristics at regular intervals: deep rough character, UV sensitivity, ampicillin resistance. Histidine auxotrophy is automatically checked in each experiment via the spontaneous rate. - Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- in the standard plate test
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no bacteriotoxic effect was observed
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- MUTAGENICITY:
No increase in the number of his+ revertants was observed in the standard plate test, with or without the addition of S9 mix in all S. typhimurium strains tested (TA1535, TA100, TA1537, TA98).
The results of the negative and positive controls were as expected and confirmed the validity and sensitivity of the test system used.
SOLUBILITY:
The test substance was incompletely soluble in DMSO from about 500 µg/plate onward.
TOXICITY:
No bacteriotoxic effect (reduced his- background growth) was observed in the standard plate test with and without S9-mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Maximum revertants/plate and corresponding test concentrations in the preincubation test:
1st experiment: |
|||
Strain |
Tested compound |
Maximum revertants/plate [corresponding dose unit in µg/plate] |
|
|
|
without S9-mix |
with S9-mix |
S. typhimurium TA1535 |
DMSO |
14 ± 2 |
16 ± 4 |
Test substance |
28 ± 22 [5000] |
15 ± 1 [20] |
|
Positive Control |
1983 ± 231 [5; MNNG] |
526 ± 22 [10; 2 -AA] |
|
S. typhimurium TA100 |
DMSO |
115 ± 20 |
97 ± 8 |
Test substance |
104 ± 15 [2500] |
116 ± 11 [100] |
|
Positive Control |
1717 ± 35 [5; MNNG] |
1905 ± 65 [10; 2 -AA] |
|
S. typhimurium TA1537 |
DMSO |
6 ± 2 |
7 ± 3 |
Test substance |
8 ± 2 [2500] |
10 ± 3 [20] |
|
Positive Control |
654 ± 235 [10; NOPD] |
141 ± 20 [10; 2 -AA] |
|
S. typhimurium TA98 |
DMSO |
17 ± 2 |
33 ± 7 |
Test substance |
23 ± 1 [500] |
37 ± 4 [20] |
|
Positive Control |
789 ± 200 [100; AAC] |
1537 ± 93 [10; 2 -AA] |
|
2nd experiment |
|||
Strain |
Tested compound |
Maximum revertants/plate [corresponding dose unit in µg/plate] |
|
|
|
without S9-mix |
with S9-mix |
S. typhimurium TA1535 |
DMSO |
15 ± 2 |
18 ± 3 |
Test substance |
14 ± 2 [2500] |
18 ± 2 [500] |
|
Positive Control |
1260 ± 122 [5; MNNG] |
236 ± 26 [10; 2 -AA] |
|
S. typhimurium TA100 |
DMSO |
120 ± 5 |
118 ± 14 |
Test substance |
116 ± 14 [100] |
117 ± 12 [500] |
|
Positive Control |
1407 ± 70 [5; MNNG] |
1433 ± 61 [10; 2 -AA] |
|
S. typhimurium TA1537 |
DMSO |
9 ± 2 |
10 ± 2 |
Test substance |
10 ± 3 [5000] |
11 ± 4 [500] |
|
Positive Control |
557 ± 100 [10; NOPD] |
131 ± 18 [10; 2 -AA] |
|
S. typhimurium TA98 |
DMSO |
25 ± 1 |
37 ± 4 |
Test substance |
24 ± 3 [100] |
39 ± 7 [2500] |
|
Positive Control |
665 ± 88 [100; AAC] |
743 ± 95 [10; 2 -AA] |
|
2-AA = 2-aminoanthracene |
|||
MNNG = N-methyl-N'-nitro-N-nitrosoguanidine |
|||
NOPD = 4-nitro-o-phenylenediamine |
|||
AAC = 9-aminoacridine |
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.
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