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EC number: 700-578-0 | CAS number: -
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The reliability is rated 1 because the study followed the standard guideline of reference (OECD 471), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.
- IUPAC Name:
- Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.
- Details on test material:
- - Name of test material (as cited in study report): Sepisol Fast Violet 2B
- Substance type: organic
- Physical state: dark violet powder
- Analytical purity: 98%
- Lot/batch No.: 423393
- Storage condition of test material: TA (20°C +/-2)
Constituent 1
Method
- Target gene:
- histidine operon
and tryptophan operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0.5; 1.5; 5; 15; 50 µg/plate
- Vehicle / solvent:
- - solvent used: ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); and preincubation for the second assay with S9 mix if the first one was negative.
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 to 72 hours
- Expression time (cells in growth medium):number of revertant colonies per plate
NUMBER OF REPLICATIONS: 1
NUMBER OF CELLS EVALUATED: 5 x 10 E 9
DETERMINATION OF CYTOTOXICITY
- Method: bacteriostatic activity
OTHER:
-Number of plates per assay: 3 - Evaluation criteria:
- R = (Number of revertants colonies wiith the test material) / (Number of revertant colonies without the test material)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Bacterioastatic activity: Cytotoxic rate of 72% was observed with 50 µg/plate of test material. This rate stands below the tolerated threshold of 75%.
No cytotoxic effect observed for the other doses.
COMPARISON WITH HISTORICAL CONTROL DATA:
Rate of spontaneous revertants and positive controls (with and without S9 mix) fall within the range of observed historical values at the facility.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
For TA 1535, TA 98, TA 100 and E.coli, a significative decrease of the number of revertants colonies can be observed for the dose 50 µg/plate.This
finding must be correlated with the high toxicity measured at this concentration..
Any other information on results incl. tables
STRAIN |
DOSE/PLATE (µg) |
R |
|||
Assay 1: - S9 mix 10% |
Assay 1: + S9 mix 10% |
Assay 2: - S9 mix 10% |
Assay 2: - S9 mix 10% and pre-incubation |
||
TA 1535 |
50 |
0.31 |
0.53 |
0.15 |
0.43 |
15 |
1.08 |
0.80 |
0.85 |
1.04 |
|
5 |
1.42 |
0.83 |
1.19 |
1.00 |
|
1.5 |
0.88 |
0.85 |
0.85 |
1.04 |
|
0.5 |
1.08 |
0.75 |
1.04 |
1.07 |
|
|
|||||
TA 1537 |
50 |
0.60 |
2.52 |
0.42 |
2.42 |
15 |
1.75 |
2.22 |
2.58 |
1.13 |
|
5 |
2.25 |
1.22 |
2.67 |
1.48 |
|
1.5 |
125 |
0.96 |
1.42 |
1.00 |
|
0.5 |
0.85 |
1.00 |
1.33 |
0.94 |
|
|
|||||
TA 98 |
50 |
0.39 |
0.74 |
0.45 |
1.02 |
15 |
0.49 |
1.18 |
1.34 |
0.79 |
|
5 |
1.14 |
1.20 |
1.21 |
1.03 |
|
1.5 |
1.00 |
1.02 |
1.04 |
0.81 |
|
0.5 |
0.86 |
0.86 |
1.11 |
1.03 |
|
|
|||||
TA 100 |
50 |
0.30 |
0.38 |
0.36 |
0.66 |
15 |
0.66 |
0.51 |
0.63 |
0.87 |
|
5 |
0.95 |
0.85 |
0.83 |
0.90 |
|
1.5 |
1.06 |
1.03 |
0.96 |
1.01 |
|
0.5 |
1.01 |
1.00 |
1.04 |
0.91 |
|
|
|||||
E.Coli |
50 |
0.18 |
0.56 |
0.55 |
0.10 |
15 |
0.50 |
1.25 |
0.73 |
0.34 |
|
5 |
1.01 |
0.92 |
0.99 |
0.91 |
|
1.5 |
0.72 |
0.98 |
0.92 |
1.15 |
|
0.5 |
0.97 |
1.07 |
1.06 |
1.32 |
R = (Number of revertants colonies wiith the test material) / (Number of revertant colonies without the test material)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions described, the test material Sepisol Fast Violet 2B did not show any mutagenic activity regarding 4 strains of
Salmonella typhimurium (TA 1535, TA 1537, TA 100 and TA 98) and regarding one strain of Escherichia Coli WP2 (uvr A-) (pKM 101) with and
without metabolic activation. - Executive summary:
The search for any mutagenic activity of Sepisol Fast Violet 2B, was studied by means of the Ames test (Salmonella his- and E.coli Trp- /microsome system) in compliance with the OECD Guideline 471 using the maximum tolerated concentration (standing below the threshold of 75%) recommended by OECD Guideline, i.e. 50μg/plate for this toxicity assay. Four lower dilutions chosen according to a geometrical (half-log) ratio were also tested.
Preparation of test material solution
The test material (Sepisol Fast Violet 2B) is diluted in ethanol so as to prepare a stock solution of 2 mg/mL.
Preliminary assay: Cytotoxicity
Different concentrations have been tested (0.5; 1; 5; 15; 25; 50; 100; 500; 1500 and 5000 µg/plate). 0.1 mL of a bacterial suspension from a culture containing 1 to 5 x 109bacteria/mL and 0.1 mL of the test item at the relevant concentration were successively added to 2 mL of top agar to which 10 % of 0.5 mM biotin histidine solution, maintained in a state of superfusion at 45°C, has been added. The content of each tube was agitated, then spread out in a Petri plate containing 20 mL of minimum agar and then incubated for 24 or 48 hours at 37 °C (n=3). Colonies are counted. A negative sample with pure solvent is run the same way.
Mutagenicity test
- Without metabolic activation:
The following technic was performed for Salmonella strains used in the test: 0.1 mL of a bacterial suspension containing 1 to 5 x 109bacteria/mL and 0.1 mL of the test item at the relevant concentration were successively added to 2 mL of top agar to which 10 % of 0.5 mM biotin histidine solution, maintained in a state of superfusion at 45°C, has been added. The content of each tube was agitated, then spread out in a Petri plate containing 20 mL of minimum agar.
For E.Coli the following technic was applied: 0.1 mL of a bacterial suspension containing 1 to 5 x 109bacteria/mL and 0.1 mL of the test item at the relevant concentration were successively added to 2 mL of top agar to which 5 % (v/v) of Nutrient broth n°2 and an extra 5µL of a L-Tryptophan solution at 2 mg/mL, maintained in a state of superfusion at 45°C, has been added. The content of each tube was agitated, then spread out in a Petri plate containing 20 mL of minimum agar.
Three plates were used per dose. The plates were then incubated at 37°C for 48 h approximately. Finally, colonies of revertants were counted for each plate.
- With metabolic activation :
Two techniques have been used:
- direct plate incorporation: Same technique as the one described above except that immediately before spreading in the
plates, 0.5 mL of the S9 mix metabolic activation system was added in soft agar.
- by pre-incubation: The bacterial mixture, the test material, and the S9 fraction is first incubated at 37 °C during at least
20 minutes before being added to the top agar.
If the first assay gives a positive response, the incorporation plate method has been used for the second S9 mix assay.
If the first assay gives a negative response, the pre-incubation method has been used for the the second S9 mix assay.
Solvent controls, positive controls were performed like in the mutagenicity assay without metabolic activation.
Bacterioastatic activity
Bacterioastatic activity: Cytotoxic rate of 72% was observed with 50 µg/plate of test material. This rate stands below the tolerated
threshold of 75%. No cytotoxic effect observed for the other doses.
For TA 1535, TA 98, TA 100 and E.coli, a significative decrease of the number of revertants colonies can be observed for the dose 50 µg/plate. This finding must be correlated with the high toxicity measured at this concentration.
Mutagenicity assays
The mutagenic activity of the test item was assessed by means of the Ames’s test in the four Salmonella typhimurium strains
TA1535, TA1537, TA98, TA100 and in the E. Coli WP2 (uvr A-) (pKM 101) tested either in presence or in absence of metabolic activation, in two independent assays. No mutagenic activity was found either with or without metabolic activation in any of the 5 strains. Values fall within the range of historical values observed at the facility.
For the Salmonella TA 1537 strain, an increase of the number of revertants at the 5; 15 and 50 µg/plate dose was observed. Nonetheless the mutagenic effet is only taken into account when the revertants' number is at least equal to 3 times the spontaneous revertant's rate for the TA 1537.
Conclusion
Under the experimental conditions described, the test material Sepisol Fast Violet 2B did not show any mutagenic activity regarding 4
strains of Salmonella typhimurium (TA 1535, TA 1537, TA 100 and TA 98) and Escherichia coli WP2 (uvr A-) (pKM 101) with and without metabolic activation, according to the OECD guideline 471.
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