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EC number: 700-579-6 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) 2-(dodecan-5-yl)-4-(4-sulfonatophenoxy)benzene-1-sulfonate 2-(dodecan-5-yl)-4-[3-(dodecan-5-yl)-4-sulfonatophenoxy]benzene-1-sulfonate
- EC Number:
- 700-579-6
- Molecular formula:
- C90H114O7S2N6 (MW = 1454) and C102H138O7S2N6 (MW = 1622)
- IUPAC Name:
- tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) 2-(dodecan-5-yl)-4-(4-sulfonatophenoxy)benzene-1-sulfonate 2-(dodecan-5-yl)-4-[3-(dodecan-5-yl)-4-sulfonatophenoxy]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Batch N° 310551
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:
- 50; 150; 500; 1500 and 5000 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
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 to 72 hours
- Expression time (cells in growth medium):number of revertant coloniesper plate
STAIN (for cytogenetic assays): Methyl violet
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
- Key result
- 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
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Bacterioastatic activity: Cytotoxic rate of 50,5%, 23,5 % and 13,5% were observed with respectively 5000, 1500 and 500 µg/plate of test material.Those rates stand below the tolerated threshold of 75%. No cytotoxic effect observed for the following doses: 150 et 50 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA:
the rates 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:
A significative decrease of the number of revertants colonies is observed for the dose 5000 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 |
5000 |
0,26 |
0,31 |
0,08 |
0,13 |
1500 |
0,89 |
0,81 |
0,35 |
0,55 |
|
500 |
1,04 |
0,94 |
0,42 |
0,58 |
|
150 |
0,93 |
1,03 |
0,73 |
0,90 |
|
50 |
1,07 |
1,22 |
0,73 |
0,97 |
|
|
|||||
TA 1537 |
5000 |
0,16 |
0,42 |
0,20 |
0,19 |
1500 |
0,58 |
0,85 |
0,47 |
0,68 |
|
500 |
0,74 |
0,58 |
0,4 |
0,61 |
|
150 |
1,37 |
0,73 |
0,47 |
0,74 |
|
50 |
0,95 |
1,04 |
0,73 |
0,87 |
|
|
|||||
TA 98 |
5000 |
0,53 |
1,4 |
0,44 |
0,55 |
1500 |
0,74 |
0,84 |
0,46 |
0,77 |
|
500 |
0,60 |
0,81 |
0,90 |
1,08 |
|
150 |
0,83 |
1,21 |
0,90 |
1,18 |
|
50 |
0,96 |
1,26 |
0,76 |
1,23 |
|
|
|||||
TA 100 |
5000 |
0,05 |
0,06 |
0,06 |
0,22 |
1500 |
0,12 |
0,16 |
0,19 |
0,24 |
|
500 |
0,13 |
0,45 |
0,36 |
0,36 |
|
150 |
0,32 |
0,86 |
0,35 |
0,88 |
|
50 |
0,65 |
0,98 |
0,77 |
0,91 |
|
|
|||||
E.Coli |
5000 |
0,14 |
0,33 |
0,13 |
0,22 |
1500 |
0,26 |
0,25 |
0,31 |
0,43 |
|
500 |
0,30 |
0,66 |
0,51 |
0,89 |
|
150 |
0,44 |
0,66 |
0,75 |
1,01 |
|
50 |
0,62 |
1,42 |
0,82 |
1,09 |
R = (Number of revertants colonies wiith the test material) / (Number of revertant colonies without the test material)
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions described, the test material Sepisol Fast Blue 85219 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 actvation.
- Executive summary:
The search for any mutagenic activity of Sepisol Fast Blue 85219, 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 concentration recommended by OECD Guideline, i.e. 5000 μg/plate for the toxicity assay. Four lower dilutions chosen according to a geometrical (half-log) ratio were also tested. In the main assay, the maximum dose was chosen in accordance with the recommendations of OECD Guideline, i.e. 5000μg/plate.
Preparation of test material solution
The test material (Sepisol Fast Blue 85219) is diluted in ethanol so as to prepare a stock solution of 100 mg/L.
Preliminary assay: Cytotoxicity
Five concentrations have been tested (50; 150; 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 each one of the 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 treatment. 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. The first method (plate incorporation) was the same 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. The other method: Pre-incubation, in which the mixture of bacteria, the test material, and the S9 fractioin is first incubated at 37 °C during at least 20 minutes before to be added to the top agar.
For the first essay, incorporation plate method have been used. The pre-incubation method have beee used for the second assay with S9 mix.
Solvent controls, positive controls and assay for the control of media sterility were performed like in the mutagenicity assay without metabolic activation.
Bacterioastatic activity
Cytotoxic rate of 50,5%, 23,5 % and 13,5% were observed with respectively 5000, 1500 and 500 µg/plate of test material. Those rates stand below the tolerated threshold of 75%. No cytotoxic effect observed for the following doses: 150 et 50 µg/plate.
A significative decrease of the number of revertants colonies is observed for the dose 5000 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.
Conclusion
Under the experimental conditions described, the test material Sepisol Fast Blue 85219 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 actvation.
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