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EC number: 208-336-1 | CAS number: 522-75-8
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenic activity of 27 dyes and related chemicals in the Salmonella/microsome and mouse lymphoma TK +/- assays
- Author:
- T.P. Cameron, T.J. Hughes, P.E. Kirby, V.A. Fung and V.C. Dunkel
- Year:
- 1 987
- Bibliographic source:
- Mutation Research, 189 (1987) 223-261
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Evaluate mutagenicity of test substance by the mouse lymphoma TK assay.
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
- EC Number:
- 212-728-8
- EC Name:
- Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
- Cas Number:
- 860-22-0
- Molecular formula:
- C16H10N2O8S2.2Na
- IUPAC Name:
- disodium 3,3'-dioxo-1,1',3,3'-tetrahydro-2,2'-biindole-5,5'-disulfonate
- Reference substance name:
- Indigo tin disulfonate sodium
- IUPAC Name:
- Indigo tin disulfonate sodium
- Details on test material:
- - Name of test material (as cited in study report): C.I. Acid blue 74
- Molecular formula (if other than submission substance):
C16-H10-N2-O8-S2.2Na
C16-H8-N2-Na2-O8-S2
C16-H8-N2-O8-S2.2Na
- Molecular weight (if other than submission substance): 466.3572 g/mol
- Substance type: Organic
- Physical state: Solid
Purity: 85%
Constituent 1
Constituent 2
Method
- Target gene:
- mouse lymphoma assay
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- Type and identity of media: The cells were grown in Fischer's medium for leukemic cells of mice (Gibco, Grand Island, NY) supplemented with 10% horse serum (Gibco, Grand Island, NY), antibiotics (50 U
penicillin/mi and 50 /µg streptomycin/ml), and 0.02% Pluronic F-68 (BASF Wyandotte Corp., Wyandotte, MI). All serum lots were prescreened for their ability to support optimal growth.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: No data
- Periodically "cleansed" against high spontaneous background: : No data - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Without S9: 971, 971, 1229, 1229, 1486, 1486, 1743, 1743, 2000 and 2000 µg/ml
With S9: 92, 206, 332, 439, 439, 556 and 556 µg/ml - Vehicle / solvent:
- Vehicle
- Vehicle(s)/solvent(s) used: Yes
- Justification for choice of solvent/vehicle: No data available
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: Ethyl methanesulfonate at 0.5 µl/ml with metabolic activation: 3-methylcholanthrene at 5.0 or 10.0 µg/ml.
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: No data available
- Exposure duration: 4 hr
- Expression time (cells in growth medium): 48 hr
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available - Evaluation criteria:
- Mutant frequencies were expressed as mutants per 10⁴ surviving cells. In general, a response was considered positive if there was a dose-related increase in the mutant frequency above the spontaneous control frequency, with a 2-fold increase at more than 1 dose and relative total growth greater than 10%.
- Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data available
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Aroclor-1254-induced male Fischer 344 rats
Any other information on results incl. tables
Concentration µl/ml |
S9 |
Relative suspension growth (%) |
Relative cloning efficiency (%) |
Relative total growth (%) |
Average no. colonies TFT/viable |
Mutant frequency (per 10⁴) |
0.0 |
- |
|
|
|
|
x0.61 |
971 |
- |
100 |
113 |
112 |
82/230 |
0.71 |
971 |
- |
103 |
108 |
111 |
71/221 |
0.64 |
1229 |
- |
45 |
95 |
43 |
59/194 |
0.61 |
1229 |
- |
102 |
84 |
86 |
66/172 |
0.7 |
1486 |
- |
102 |
91 |
93 |
62/185 |
0.67 |
1486 |
- |
100 |
96 |
95 |
49/195 |
0.50 |
1743 |
- |
101 |
88 |
88 |
47/179 |
0.53 |
1743 |
- |
93 |
92 |
86 |
47/187 |
0.50 |
2000 |
- |
96 |
86 |
83 |
44/175 |
0.50 |
2000 |
- |
108 |
94 |
101 |
55/192 |
0.57 |
Positive control |
- |
47 |
29 |
13 |
306/58 |
10.55 |
Solventᵃ |
- |
|
|
|
|
x0.56 |
Concentration µl/ml |
S9 |
Relative suspension growth (%) |
Relative cloning efficiency (%) |
Relative total growth (%) |
Average no. colonies TFT/viable |
Mutant frequency (per 10⁴) |
0.0 |
+ |
|
|
|
|
X0.53 |
92 |
+ |
51 |
45 |
23 |
131/106 |
2.47 |
206 |
+ |
37 |
44 |
16 |
131/102 |
2.57 |
332 |
+ |
37 |
49 |
18 |
137/114 |
2.40 |
439 |
+ |
34 |
40 |
14 |
130/94 |
2.77 |
439 |
+ |
31 |
46 |
14 |
124/108 |
2.30 |
556 |
+ |
26 |
50 |
13 |
134/116 |
2.31 |
556 |
+ |
25 |
40 |
10 |
125/93 |
2.69 |
Positive control |
+ |
65 |
56 |
36 |
191/96 |
3.98 |
Solventb |
+ |
|
|
|
|
X0.61 |
a: Solvent control for test chemical.
b: Solvent for positive control.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative Negative (with and without)
The substance is considered to be not mutagenic in L5178Y TK +/- mouse lymphoma cells with and without metabolic activation. - Executive summary:
Test chemical tested for mutagenicity in mouse lymphoma TK⁺′⁻ assay. toxicity of test chemical was determined both with and without S9 prepared from Aroclor-1254-induced male Fischer 344 rats. L5178Y TK +/- mouse lymphoma cells was exposed to Without S9: 971, 971, 1229, 1229, 1486, 1486, 1743, 1743, 2000 and 2000 µg/ml and positive control is Ethyl methanesulfonate at 0.5 µl/ml. With S9: 92, 206, 332, 439, 439, 556 and 556 µg/ml concentration of test chemical and positive control is 3-methylcholanthrene at 5.0 or 10.0 µg/ml. There was no dose-related increase in the mutant frequency above the spontaneous control frequency, no 2-fold increase at more than 1 dose and not relative total growth greater than 10% at any exposed concentration.
Hence, the substance is considered to be not mutagenic inL5178Y TK +/- mouse lymphoma cells with and without metabolic activation.
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