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EC number: 309-627-7 | CAS number: 100545-46-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2017-04-07 to 2017-07-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(cyclohexylamino)propyl]amino]sulfonyl derivs.
- EC Number:
- 309-627-7
- EC Name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(cyclohexylamino)propyl]amino]sulfonyl derivs.
- Cas Number:
- 100545-46-8
- Molecular formula:
- C32H16-τN8Cu.(SO3)m.(SO3H)p.(C9H19N2SO2)O.(C9H20N2SO2)n
- IUPAC Name:
- Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(cyclohexylamino)propyl]amino]sulfonyl derivs.
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Method
- Target gene:
- His D for Salmonella typhimurium TA 98
His C for Salmonella typhimurium TA 1537
His G for Salmonella typhimurium TA 1535 and TA 100
Tryp E for Escherichia coli WP2 (uvr A-) (pKM101)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction, microsome fraction prepared from Sprague Dawley rat liver homogenate
- Test concentrations with justification for top dose:
- 50, 150, 500 1500 and 5000 µg/plate
Selection of the top dose: The preliminary cytotoxicity test performed on the TA 100 showed that neither original solutions nor dilutions have bacteriostatic effect. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: ethanol was found to be an appropriate solvent, to obtain an homogeneous suspension
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: Cis-Platinum (II), 2-anthramine and Dimethyl-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- First assay: direct incorporation method, +/- S9 mix
- Second assay: pre-incubation test method +/- S9 mix
DURATION
- Preincubation period: 30 min at 37°C preincubation procedure used.
- Exposure duration:48-72 hr at 37°C
- Expression time (cells in growth medium): counting completed at the end of the exposure period in each plate
NUMBER OF REPLICATIONS: Triplicate, in parallel with negative, solvent and positive controls.
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertant colonies or a clearing or diminution of the background lawn. - Evaluation criteria:
- Ensure that the criteria validity of the study are well respected namely :
- The bacteriostatic activity of the highest concentration tested shall be equal or less than 75%
- The spontaneous reversion rate of the absolute negative control shall comply with the historical values of the laboratory
- The spontaneous reversion rate of the solvent shall not be statistically different from absolute negative control
- The mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/ or without metabolic activation shall comply with the historical values of the laboratory
- Negative and positive values should not show significant difference with the historical values of the laboratory (+/- 2 standards deviation) - Statistics:
- Not provided
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- 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
Applicant's summary and conclusion
- Conclusions:
- Doses (5000, 1500, 500, 150 and 50 µg/plate) performed from suspensions of the test item SEPISOL FAST BLUE GD BATCH: 616587 (LEMI code : GJV240317-2), provided by BIMA 83 do not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA-)(pKM 101) without or with metabolic activation, according to the OECD Guidelines n°471.
- Executive summary:
Asssay: Bacterial reverse mutation test using "Salmonella typhimurium his-" and "Escherichia coli" WP2(uvrA-)(pKM101) according to OECD n°471 (LEMI operating procedure n°MB08/45).
Suspensions (GJV020517-S2 and GJV090517-S2) obtained from GJV240317-2, have been tested for their capacity to induce reverse mutation in four Salmonella typhimurium strains and one Escherichia coli WP(uvrA-)(pKM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays were carried out.
For assay n°1, various concentrations of GJV020517-S2 were put in contact with the strains in the absence and presence of metabolic activation system (S9 -mix 10% (v/v)).
For assay n°2, various concentrations of GJV090517-S2 were put in contact with the strains in the absence of metabolic activation and with pre-activation in the presence of metabolic activation system (S9 -mix 10% (v/v)).
For the two assays, negative and positive controls were carried out in parallel. Positive controls induced a significant increase in the number of revertant colonies compared to negative controls. There is no significant difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental "historical data" values obtained in the laboratory.
These results validate the two tests.
There is no evidence of any increase in the number of revertant colonies in the presence of the various concentration of the test item (5000, 1500, 500, 150 and 50 µg/plate) without and with metabolic activation in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA-)(pKM 101).
Conclusion:
Doses (5000, 1500, 500, 150 and 50 µg/plate) prepared from suspensions of the test item do not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100, and in Escherichia coli WP2(uvrA-)(pKM 101) without, or with metabolic activation, according to the OECD Guidelines n°471.
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