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EC number: 235-440-4 | CAS number: 12227-78-0
- 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:
- weight of evidence
- 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 mentioned below
- Principles of method if other than guideline:
- Mutagenicity testing was performed by the standard plate-incorporation assay for C I -ACID RED 51 in Salmonella typhimurium by using TA1535, TA1537, TA1538, TA98 and TA100 strains.
- GLP compliance:
- no
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 240-474-8
- EC Name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 16423-68-0
- Molecular formula:
- C20H8I4O5.2Na
- IUPAC Name:
- disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Reference substance name:
- erythrosine BS
- IUPAC Name:
- erythrosine BS
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): C I ACID RED 51
- Molecular formula (if other than submission substance): C20-H6-I4-O5.2Na
- Molecular weight (if other than submission substance): 879.8424 g/mol
- Substance type: Organic
- Physical state: Solid(Powder)
-Purity: 90.5% dye
- Impurities (identity and concentrations): 6.6%H20
2 0% NaCl
0.3% Na2SO4
Constituent 1
Constituent 2
Method
- Target gene:
- S.typhimurium mutagenicity assay
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA100 and TA98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- The test concentration were
33 .0µg/plate
100 .0µg/plate
333.0 µg/plate
1000.0µg/plate
3333.0µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: The solvents used were water, dimethyl sulfoxide, and acetone (exact solvent was not mention)
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 the positive controls were as fallow:Sodium azide for strains TA1535 and TA100; 9-aminoacridine for TA1537; 2-nitrofluorene for TA1538 and TA98 with metabolic activationaminoanthracene for TA1535, TA1537, TA1538, TA98 TA100
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: plate incorporation.
DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): 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: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available
OTHER: The chemical was tested at 5 dose levels in triplicate. - Evaluation criteria:
- A response was considered positive if there was a
dose-related increase in the number of revertants above spontaneous solvent controls - Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA100 and TA98 were used.
- 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:
- RANGE-FINDING/SCREENING STUDIES: The range of
concentrations for testing was based on preliminary
toxicity tests in which the viability of the bacterial cells on complete medium was measured at concentrations up to 10 mg/plate or to the limit of solubility. When solubility and toxicity were not limiting factors, the maximum concentration tested was 10 mg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Other:
S. typhimuriumASSAY
Dose(µg/plate) |
Revertants per plate |
||
TA1535 |
|||
(-S)S9 (R)S9 (H)S9 |
|||
Solvent Cont. |
30±7 |
16±6 |
20±6 |
Positive Cont.b |
380±6 |
198±172 |
119±7 |
33.00 |
21±3 |
19±3 |
18±2 |
100.00 |
28±3 |
21±6 |
21±4 |
333.00 |
19±4 |
15±2 |
16±2 |
1000.00 |
15±4 |
9±1 |
10±1 |
3333.00 |
14±2 |
13±3 |
11±3 |
Dose(µg/plate) |
Revertants per plate |
||
TA1537 |
|||
(-S)S9 (R)S9 (H)S9 |
|||
Solvent Cont. |
5±2 |
9±5 |
9±3 |
Positive Cont.b |
199±30 |
36±282 |
79±6 |
33.00 |
5±4 |
7±2 |
9±8 |
100.00 |
8±3 |
10±3 |
5±2 |
333.00 |
6±3 |
6±3 |
9±1 |
1000.00 |
5±1 |
5±2 |
7±6 |
3333.00 |
5±1 |
4±4 |
7±2 |
Dose(µg/plate) |
Revertants per plate |
||
TA1538 |
|||
(-S)S9 (R)S9 (H)S9 |
|||
Solvent Cont. |
15±3 |
19±4 |
22±3 |
Positive Cont.b |
191±161 |
1040±332 |
525±15 |
33.00 |
16±4 |
22±5 |
14±9 |
100.00 |
12±5 |
16±4 |
14±9 |
333.00 |
12±2 |
21±7 |
15±4 |
1000.00 |
9±2 |
14±6 |
19±4 |
3333.00 |
11±1 |
14±1 |
10±5 |
Dose(µg/plate) |
Revertants per plate |
||
TA98 |
|||
(-S)S9 (R)S9 (H)S9 |
|||
Solvent Cont. |
21±3 |
34±5 |
34±3 |
Positive Cont.b |
196±342 |
1086±742 |
991±25 |
33.00 |
18±4 |
25±11 |
24±2 |
100.00 |
17±5 |
27±5 |
26±6 |
333.00 |
19±4 |
31±2 |
25±9 |
1000.00 |
15±5 |
23±6 |
20±6 |
3333.00 |
13±4 |
12±2 |
20±7 |
Dose(µg/plate) |
Revertants per plate |
||
TA100 |
|||
(-S)S9 (R)S9 (H)S9 |
|||
Solvent Cont. |
171±14 |
156±13 |
191±26 |
Positive Cont.b |
571±7 |
1630±632 |
1214±61 |
33.00 |
179±21 |
138±2 |
160±21 |
100.00 |
168±11 |
136±10 |
189±21 |
333.00 |
106±10 |
163±20 |
179±34 |
1000.00 |
117±35 |
164±14 |
175±7 |
3333.00 |
102±33 |
138±5 |
171±9 |
aMean and standard deviation. bin assays without metabofic activation, the positive controls were sodium azide for TA1535 and TA100, 1.0 µg/plate, 9-aminoacridine for TA1537, 50.0 µg/plate; 2-nitrofluorene for TA1538, 1.0 or 5.0 µg/plate, and for TA98, 2.0 or 5.0 µg/plate. In those assays in which the lower dose of 2-nitrofluorene was used, the positive control value is followed by a superscript indicating the dose level used (either1or2). In assays with rat-liver S9, the positive control for all strains was 2-aminoanthracene, 2.5 µg/plate except for those positive control values, followed by a numerical superscript. This number is the dose used as a positive control. In assays with hamster-liver S9, the positive control for all strains was 2-aminoanthracene, 1.0 µg/plate, except for those positive controls followed by the superscript "c". In these cases 2.5µg/plate was used. 1 Dose level was 1.0 µg/plate. 2 Dose level was 2.0 µg/plate. 5 Dose level was 5.0 µg/plate. c Dose level was 2.5 µg/plate. d Only 2 plates
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative Negative (with and without S9 mix)
The dye C. I -ACID RED 51 was found to be negative ti induce gene mutation with and without S9 mix in Salmonella typhimurium strains TA1535, TA1537, TA1538, TA100 and TA98 by Plate-incorporation assay. - Executive summary:
Bacterial gene mutation assay was performed for the test material C. I -ACID RED 51 inSalmonella typhimuriumTA1535, TA1537, TA1538, TA100 and TA98 strains at a dose range of 33.0, 100.0, 333.0, 1000.0and3333.0µg/plate by Plate-incorporation method.
Chemical was tested without metabolic activation and with S9 mix from Aroclor 1254-induced male Fischer 344 rats and Syrian golden hamsters. Appropriate positive and solvent controls were also incorporated in the study.
C. I -ACID RED 51 failed to induce gene mutation in the bacterial strains TA1535, TA1537, TA1538, TA100 and TA98.
According to the CLP regulation, the test material C. I -ACID RED 51 does not classify as a gene mutant.
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