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EC number: 941-151-0 | CAS number: 1690331-63-5
- 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
- Study period:
- From 03 December 2012 to 21 December 2012
- 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:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [bis(phenylamino)methylidene]azanium 3-[(1E)-2-[4-(phenylamino)phenyl]diazen-1-yl]benzene-1-sulfonate
- EC Number:
- 941-151-0
- Cas Number:
- 1690331-63-5
- Molecular formula:
- C31H28N6SO3
- IUPAC Name:
- [bis(phenylamino)methylidene]azanium 3-[(1E)-2-[4-(phenylamino)phenyl]diazen-1-yl]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sepisol Fast Yellow MG-DPG
- Substance type: monoconstituent
- Physical state : powder
- Stability under test conditions: stable
- Storage condition of test material: room temperature (23 +/- 5°C) and protected from light
Constituent 1
Method
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 from liver of rodent treated with Aroclor
- Test concentrations with justification for top dose:
- C1 : 0.007 mg/plate
C2 : 0.021 mg/plate
C3 : 0.062 mg/plate
C4 : 0.187 mg/plate
C5 : 0.560 mg/plate
Concentration C4 to C1 were prepared by 1:3 serial dilutions in the selected solvent from the C5 concentrations. - Vehicle / solvent:
- - Solvent used: ethanol (96%)
- Justification for choice of solvent: The solubility of the test item was evaluated in a standard solvent panel (milliQ water, ethanol 96%, DMSO and corn oil). Observation of precipitation by the naked eye indicated that the test item is not soluble. The ethanol (96%) was chosen as the test item was soluble in it at a concentration of 50.0 mg/mL
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-amino-anthracene
- Remarks:
- The positive controls used are different for tests with and without metabolic activation or for different tester strains (see the "section Any other information on materials and methods incl.tables" for more details)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: under the direct incorporation ofagar medium plate and the pre-incubation procedures
DURATION
- Preincubation period: 20 min at 37°C when the pre-incubation procedure is used.
- Exposure duration: 48 hr at 37°C
- Expression time (cells in growth medium): counting completed at the end of the exposure period.
NUMBER OF REPLICATIONS: Triplicate, in parallel with vehicale and reference item controls.
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertant colonies or a clearing or diminution of the background lawn. - Evaluation criteria:
- A positive result involved taking into account a dose-response effect in the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system.
The result is considered positive whenever the number of revertants of the test item treated plates is higher than those observed in the solvent treated plates, according to the following criteria:
- TA98 strain : 2 fold higher
- TA100 strain: 2 fold higher
- TA1535 strain : 3 fold higher
- TA1537 strain : 3 fold higher
- WP2 (pkM101) : 2 fold higher
The biological relevance of the results was also considered. - Statistics:
- no statistic was used
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:
- cytotoxicity
- Remarks:
- at the highest dose of 0.560 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- cytotoxicity
- Remarks:
- at the highest dose of 0.560 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
The mean solvent control and reference item control counts complied with the laboratory historical data for each strain (see attachment)
ADDITIONAL INFORMATION ON CYTOTOXICITY:
During the cytotoxicity assay, a decrease in the number of revertant colonies > 50% compared to the solvent reference was observed indicating cytotoxicity of the test item. The lowest cytotoxic concentration was 0.560 mg/plate and used as the highest exposure concentration to perform the test (see the table in the field below) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results of test item cytotoxicity assay
Amount/plate |
Revertants/plate |
Mean |
S.D. |
R |
||||
Solvent: |
ethanol (96%) |
- |
92 |
80 |
95 |
89 |
7.9 |
- |
Test item |
Sepisol |
5.00 |
1 |
2 |
1 |
1 |
0.6 |
0.0 |
(mg) |
Fast |
1.67 |
0 |
1 |
0 |
0 |
0.6 |
0.0 |
|
Yellow |
0.56 |
6 |
4 |
9 |
6 |
2.5 |
0.1 |
|
MG-DPG |
0.19 |
95 |
82 |
84 |
87 |
7.0 |
1.0 |
|
|
0.06 |
89 |
98 |
96 |
94 |
4.7 |
1.1 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item does not induce point mutations or frame-shifts in the genome of the bacterial strains with or without metabolic activation regardless of the procedure. Therefore, at the an exposure dose range of 0.56 mg/plate to 0.007 mg/plate, the test item is considered to be non mutagenic/non pro-mutagenic under the experimental conditions assayed. - Executive summary:
The bacterial reverse mutation test (Ames test) assesses the mutagenic or promutagenic potential of the test item SEPISOL FAST YELLOW MG-DPG in several bacterial strains.
The test was performed in accordance with OECD Guideline 471 for the Testing of Chemicals (Bacterial Reverse Mutation Test. Adopted 21st July 1997) and the test Method B13/B14 of Commission Regulation (EC) No. 440/2008, dated May 30, 2008.
In a cytotoxicity assay, a decrease in the number of revertant colonies >50% compared to solvent reference was observed, indicating cytotoxicity of the test item. The lowest cytotoxic concentration was 0.560mg/plate and used as the highest exposure concentration for to perform the test.
Five test item doses ranging from 0.560 and 0.007 mg/plate were assayed.
None of the concentrations assayed for the test item showed an increase in the R value either with or without S9 metabolic activation regardless of the procedure.
No dose response for the test item SEPISOL FAST YELLOW MG-DPG was observed in any of the tested bacterial strains.
Based on the results obtained in this study, it can be concluded that the test item does not induce point mutations or frame-shifts in the genome of the bacterial strains with or without metabolic activation regardless of the procedure. Therefore, the test item SEPISOL FAST YELLOW MG-DPG is considered to be NON MUTAGENIC / NON PRO-MUTAGENIC under the experimental conditions assayed.
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