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EC number: 248-427-3 | CAS number: 27360-85-6
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 January 2015 to 18 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. Study report is a translation from Japanese to English.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: - see below
- Principles of method if other than guideline:
- - “Standards for Mutagencity Tests using Microorganisms” (Notification No. 77, September 1, 1988 & partial revision: Notification No. 67, June 2, 1997, Ministry of Labour, Japan and Notification No. 120, December 25, 2000, , Ministry of Labour, Japan) and the “Amendment of the Reporting Form of the Results of the Mutagenicity Tests using Microorganisms” (Notification No. 653, September 29, 1997, Labour Standards Bureau, Ministry of Labour, Japan)
- “Guidelines for Toxicity Testings of New Chemical Substances” (Notification No. 7 of 0331 Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 5 of the Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, & No. 110331009 of Environmental Policy Bureau, Ministry of the Environment, Japan, March 31, 2011) - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetrasodium [29H,31H-phthalocyaninetetrasulphonato(6-)-N29,N30,N31,N32]cuprate(4-)
- EC Number:
- 248-427-3
- EC Name:
- Tetrasodium [29H,31H-phthalocyaninetetrasulphonato(6-)-N29,N30,N31,N32]cuprate(4-)
- Cas Number:
- 27360-85-6
- Molecular formula:
- C32H12CuN8O12S4.4Na
- IUPAC Name:
- tetrasodium [29H,31H-phthalocyaninetetrasulphonato(6-)-N29,N30,N31,N32]cuprate(4-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Appearance: Purple powder
- Storage conditions: Room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine requirement in the Salmonella typhimurium strains (Histidine operon).
Tryptophan requirement in the Escherichia coli strain (Tryptophan operon).
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- - Reason for choice of the strains: These strains are very sensitive to mutagens and are the most commonly used in bacterial reverse mutation assays.
- Type and identity of media: The bacterial suspension and DMSO were mixed in a ratio of 0.8 mL to 0.07 mL. The mixture was subdivided in 0.3 mL aliquots, and then frozen and stored at -85 to -80 °C.
- Properly maintained: Yes
- Characterisation: The number of viable cell, amino acid requirement, UV sensitivity, rfa mutation, presence or absence of the drug resistance factor (R-factor plasmid) and positive control test (Dose-relation) were confirmed, and good strains were used as test strains.
Conditions of pre-culture
- Nutrient Broth: Nutrient Broth No. 2
- Pre-culture procedure
A bacterial suspension of each strain (20 µL of S. typhimurium TA strains, 5 µL of E. coli WP2 uvrA) was inoculated into an L-form culture tube (35 mL capacity) containing 10 mL of Nutrient Broth. This culture tube was left at 4 °C until starting incubation, and then incubated while shaking (100 rpm) in a water bath at 37°C for 8 hours. After incubation, the optical density was measured and the number of viable cells was calculated by growth curve for each strain. The bacterial cultures were stored at room temperature until starting the test.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test: 1.2, 4.9, 20, 78, 313, 1250 and 5000 µg/plate
Mutation Test Experiments 1 and 2: 0, 313, 625, 1250, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water for injection
- Justification for choice of solvent/vehicle: Based on information from the sponsor that the test material was soluble at >100 g/L in water; water has been chosen as the vehicle
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- furylfuramide
- other: 2-Methoxy-6-chloro-9-[3-(2-choroethyl)aminopropylamino]acridine.2HCl (ICR-191), 10Aminoanthracene (2AA)
- Remarks:
- Negative control same as solvent/vehicle control: water
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation
For tests without metabolic activation: 0.5 mL of 0.1 M Na-phosphate buffer (pH 7.4) and 0.1 mL of each fresh bacterial culture were added to each tube containing 0.1 mL of the test solution or the negative control solution.
For tests with metabolic activation: 0.5 mL of the S-9 mix was added to each tube instead of the 0.1M Na-phosphate buffer. The mixture was pre-incubated in a water bath at 37 °C for 20 minutes while shaking horizontally, and then 2.0 mL of top agar were added to the mixture, and the contents of each tube were poured over the surface of the minimal glucose agar plate; 0.1 mL of the positive control solution was carried out equally.
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
One minimal glucose agar plate was used for each dose level in the preliminary test and three minimal glucose agar plates were used for each dose level in two main tests, which were performed at the same doses.
COUNTING PROCEDURE
The number of revertant colonies was counted visually due to the colour of the test material on the plates. But the revertant colonies of positive controls were counted with a colony counter. - Evaluation criteria:
- In the two main tests, if the number of revertant colonies on the test plates increased significantly in comparison with that on the control plates (based on twice as many as that of the negative control), and dose-response and reproducibility were also observed, the test substance was to be judged positive.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The growth inhibition by the test material and the precipitate of the test material was not observed in any strains either with or without metabolic activation.
DEFINITIVE TESTS:
In the two main tests, neither an increase in the number of revertant colonies (more than twice as many as that of the negative control) nor a dose-related response was observed at any doses in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation.
The revertant colonies of the positive controls showed an increase of more than twice that of the negative controls and they were within limit of controls (mean +/- 3SD) in historical data, indicating that this study was performed correctly.
The test material has been determined to be negative in respect to gene mutagenicity.
The growth inhibition of the test strains by the test material was not observed. And the precipitate of the test material on the plates was not observed either with or without metabolic activation.
In the sterility test on the test material and the S9 mix, no growth of bacteria was observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Summary of Experiment 1
+/- S9 Mix |
Concentration (µg/plate) |
Mean number of colonies/plate |
||||
Base-pair Substitution Type |
Frameshift Type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
- |
Solvent 313 625 1250 2500 5000 |
122 106 114 114 98 99 |
10 11 9 10 11 10 |
32 28 29 30 25 27 |
24 21 20 24 27 28 |
14 9 8 7 8 9 17 |
+ |
Solvent 313 625 1250 2500 5000 |
129 108 132 121 115 112 |
10 8 10 11 8 7 |
29 31 29 26 30 23 |
34 33 37 37 33 32 |
17 17 14 13 16 13 |
Positive Controls |
||||||
- |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Concentration (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
|
Mean no. colonies/plate |
539 |
430 |
144 |
551 |
1703 |
|
+ |
Name |
B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
Concentration (µg/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
5.0 |
|
Mean no. colonies/plate |
936 |
286 |
360 |
228 |
83 |
AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (Furylfuramide)
NaN3 = Sodium azide
ICR-191 = 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine∙2HCl
B[a]P = Benzo[a]pyrene
2AA = 2-Aminoanthracene
Table 2: Summary of Experiment 2
+/- S9 Mix |
Concentration (µg/plate) |
Mean number of colonies/plate |
||||
Base-pair Substitution Type |
Frameshift Type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
- |
Solvent 313 625 1250 2500 5000 |
100 98 94 100 103 97 |
11 12 9 10 8 9 |
32 24 26 24 27 22 |
21 21 19 19 17 23 |
13 9 9 8 11 8 |
+ |
Solvent 313 625 1250 2500 5000 |
110 101 102 107 92 96 |
9 10 8 9 7 8 |
31 29 31 29 28 26 |
30 28 25 26 23 24 |
17 14 15 13 17 13 |
Positive Controls |
||||||
- |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Concentration (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
|
Mean no. colonies/plate |
574 |
377 |
127 |
520 |
1984 |
|
+ |
Name |
B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
Concentration (µg/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
5.0 |
|
Mean no. colonies/plate |
904 |
323 |
396 |
237 |
86 |
AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (Furylfuramide)
NaN3 = Sodium azide
ICR-191 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine∙2HCl
B[a]P = Benzo[a]pyrene
2AA = 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
other: negative, with and without metabolic activation
Under the conditions of the study, the test material has been determined to be negative in respect to gene mutagenicity. - Executive summary:
The potential of the test material to cause mutagenic effects in bacteria was assessed in accordance with the standardised guidelines OECD 471 and was designed to be compatible with the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities.
Furthermore, the study has been performed under GLP conditions and this particular study report is a translation from Japanese to English.
Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA were treated with the test material, using the plate incorporation and pre-incubation methods, at five dose levels, both with and without metabolic activation. The dose levels assessed were 313, 625, 1250, 2500 and 5000 µg/plate.
A dose selection test was performed, plus two main tests.
In the two main tests, neither an increase in the number of revertant colonies (more than twice as many as that of the negative control) nor a dose-related response was observed at any doses in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation.
The revertant colonies of the positive controls showed an increase of more than twice that of the negative controls and they were within limit of controls in historical data, indicating that this study was performed correctly.
The test material has been determined to be negative in respect to gene mutagenicity.
The growth inhibition of the test strains by the test material was not observed. And the precipitate of the test material on the plates was not observed either with or without metabolic activation.
In the sterility test on the test material and the S9 mix, no growth of bacteria was observed.
The test material was considered to be non-mutagenic under the conditions of this test.
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