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EC number: 224-909-9 | CAS number: 4548-53-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviwed journal
- Qualifier:
- according to guideline
- Guideline:
- other: refer below principle
- Principles of method if other than guideline:
- The purpose of this study is to present the results and data from the test chemical for their ability to induce mutations in tester strains of Salmonella typhimurium.
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA100, TA98, TA97 and TA 1535
- Details on mammalian cell type (if applicable):
- No data available
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9
- Test concentrations with justification for top dose:
- 0.00,1.000, 3.000, 10.00, 33.00, 100.00,333.00,1000.00,3333.00,10000.00 µg/Plate
- Vehicle / solvent:
- Solvent : DMSOJustification for choice of solvent/vehicle: No data available
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- mitomycin C
- other: 4-nitro-o phenylenediamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre incubationDURATION- Pre incubation period: 20 min- Exposure duration: No data available- Expression time (cells in growth medium): 2 days- 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 availableSELECTION AGENT (mutation assays): No data availableSPINDLE INHIBITOR (cytogenetic assays): No data availableSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: No data availableNUMBER OF CELLS EVALUATED: No data availableDETERMINATION OF CYTOTOXICITY- Method: No data availableOTHER EXAMINATIONS:- Determination of polyploidy: No data available- Determination of endoreplication: No data available- Other: No data available
- Evaluation criteria:
- Histidine- independent (his+) colonies arising on the plates were counted
- Statistics:
- No data available
- Species / strain:
- S. typhimurium, other: TA100, TA98, TA97 and TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS- Effects of pH: No data available- Effects of osmolality: No data available- Evaporation from medium: No data available- Water solubility: No data available- Precipitation: No data available- Other confounding effects: No data availableRANGE-FINDING/SCREENING STUDIES: yes,each chemical was initially tested in the preincubation test at half-log dose intervals up to a dose that elicited toxicity, or to a dose immediately below one that was toxic in the preliminary toxicity procedure.COMPARISON WITH HISTORICAL CONTROL DATA: No data availableADDITIONAL INFORMATION ON CYTOTOXICITY: No data available
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):negativeThe end point for the genetic toxicity test was found to be negative (with and without) when treated with Ponceau SX (4548-53-2).
- Executive summary:
Genetic toxicity test was performed by Ponceau SX onS typhimurium(Strain TA100, TA98, TA97 and TA 1535).Initial testing was in strain without activation and with 30% rat and hamster S-9. If a positive response was obtained in one or both strains, only the positive test condition was repeated. Each chemical was initially tested in the preincubation test at half-log dose intervals up to a dose that elicited toxicity, or to a dose immediately below one that was toxic in the preliminary toxicity procedure.The test chemical (0.05 ml), overnight culture of Salmonella (0.10 ml at CWR and MIC, and 0.05 ml at SRI), and S-9 mix or buffer (0.50 ml), were incubated at 37◦C, without shaking, for 20 min.At least five doses of each chemical were tested in triplicate, and repeat experiments were performed at least one week following the initial trial.A maximum of 0.05 ml solvent was added to each plate.Different concentrations used are 0, 1, 3.10, 33, 100, 333, 1000, 3333, 10000, µg/plates.X
The positive controls in the absence of metabolic activation were sodium azide (TA1535 and TA100), 9-aminoacridine (TA97 and TA 1537), 4-nitro-o phenylenediamine (TA98 and TA1538), mitomycin C (TA102), and methyl methane sulfonate (TA 104) and the positive control for metabolic activation with all strains was 2-aminoanthracene, and either sterigmatocystin or 2 aminoanthracene were used.
A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+revertants did not meet the criteria for a “+W” response, or if only single doses produced increases in his+revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet the criteria for a mutagenic or questionable response.
From the experiment onS typhimurium(Strain TA100, TA98, TA97 and TA 1535)it was concluded that thePonceau SX(CAS No 4548-53-2) was genetically non-toxic chemical with and without activation.
Reference
Dose | TA100 | |||
NA (-) NA (-) | ||||
µg/plate | MEAN | SEM | MEAN | SEM |
0.00 | 107 | 4.6 | 95 | 6.8 |
1.000 |
|
|
|
|
3.000 |
|
|
|
|
10.00 |
|
|
|
|
33.00 |
|
|
|
|
100.00 | 90 | 25.0 | 104 | 8.4 |
333.00 | 117 | 2.4 | 113 | 3.3 |
1000.00 | 133 | 3.7 | 100 | 3.2 |
3333.00 | 109 | 8.2 | 121 | 7.9 |
10000.00 | 116 | 9.0 | 96 | 4.6 |
POS | 397 | 8.0 | 502 | 9.2 |
Dose | TA100 | |||||
10% HLI (-) | 30% HLI (?) | 30% HLI (-) | ||||
µg/plate | MEAN | SEM | MEAN | SEM | MEAN | SEM |
0.00 | 107 | 1.2 | 121 | 4.2 | 110 | 9.4 |
1.000 |
|
|
|
| 113 | 3.5 |
3.000 |
|
|
|
| 100 | 3.8 |
10.00 |
|
|
|
| 93 | 3.2 |
33.00 |
|
|
|
| 115 | 3.7 |
100.00 | 83 | 4.0 | 163 | 2.9 | 112 | 2.3 |
333.00 | 104 | 6.8 | 154 | 9.9 | 120 | 3.2 |
1000.00 | 106 | 6.2 | 154 | 10.8 | 122 | 1.9 |
3333.00 | 89 | 5.2 | 150 | 11.2 | 138 | 6.1 |
10000.00 | 117 | 8.4 | 162 | 3.0 | 114 | 8.2 |
POS | 688 | 6.3 | 702 | 25.8 | 735 | 106.9 |
Dose | TA100 | |||
10% RLI (-) 30% RLI (-) | ||||
µg/plate | MEAN | SEM | MEAN | SEM |
0.00 | 106 | 12.0 | 144 | 5.0 |
1.000 |
|
|
|
|
3.000 |
|
|
|
|
10.00 |
|
|
|
|
33.00 |
|
|
|
|
100.00 | 97 | 5.7 | 131 | 2.2 |
333.00 | 94 | 8.5 | 155 | 5.2 |
1000.00 | 79 | 4.6 | 155 | 6.3 |
3333.00 | 102 | 13.9 | 146 | 1.9 |
10000.00 | 94 | 5.6 | 145 | 7.4 |
POS | 691 | 152.3 | 967 | 21.5 |
Dose | TA1535 | |||||||||
NA (-) | 10% HLI (-) | 30% HLI (-) | 10%RLI (-) | 30%RLI (-) | ||||||
µg/plate | MEAN | SEM | MEAN | SEM | MEAN | SEM | MEAN | SEM | MEAN | SEM |
0.00 | 27 | 2.6 | 23 | 3.3 | 14 | 2.9 | 18 | 3.5 | 16 | 2.0 |
1.000 |
|
|
|
|
|
|
|
|
|
|
3.000 |
|
|
|
|
|
|
|
|
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
33.00 |
|
|
|
|
|
|
|
|
|
|
100.00 | 30 | 1.2 | 17 | 1.3 | 14 | 3.4 | 25 | 1.8 | 13 | 3.2 |
333.00 | 24 | 5.5 | 15 | 2.2 | 12 | 1.2 | 17 | 4.4 | 18 | 3.2 |
1000.00 | 27 | 0.9 | 17 | 2.0 | 12 | 1.2 | 19 | 0.6 | 13 | 1.2 |
3333.00 | 30 | 5.4 | 22 | 1.0 | 18 | 1.2 | 17 | 3.0 | 13 | 1.9 |
10000.00 | 30 | 3.5 | 13 | 0.9 | 17 | 0.3 | 22 | 1.5 | 12 | 2.0 |
POS | 327 | 20.3 | 145 | 2.8 | 188 | 12.2 | 1612x |
| 183 | 4.0 |
Dose | TA97 | |||||||||
NA (-) | 10% HLI (-) | 30% HLI (-) | 10%RLI (-) | 30%RLI (-) | ||||||
µg/plate | MEAN | SEM | MEAN | SEM | MEAN | SEM | MEAN | SEM | MEAN | SEM |
0.00 | 113 | 4.7 | 145 | 10.4 | 141 | 8.4 | 153 | 0.7 | 163 | 1.7 |
1.000 |
|
|
|
|
|
|
|
|
|
|
3.000 |
|
|
|
|
|
|
|
|
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
33.00 |
|
|
|
|
|
|
|
|
|
|
100.00 | 118 | 8.2 | 129 | 7.6 | 146 | 9.2 | 135 | 3.8 | 146 | 4.1 |
333.00 | 122 | 10.7 | 137 | 2.3 | 136 | 6.7 | 143 | 10.3 | 144 | 2.3 |
1000.00 | 104 | 6.1 | 140 | 4.7 | 160 | 2.1 | 136 | 1.2 | 139 | 7.7 |
3333.00 | 89 | 25.0 | 146 | 0.9 | 150 | 7.6 | 134 | 5.3 | 135 | 4.4 |
10000.00 | 116 | 1.2 | 159 | 4.6 | 131 | 10.8 | 130 | 4.7 | 119 | 3.8 |
POS | 582 | 16.5 | 932 | 175.2 | 994 | 65.9 | 2046 | 86.0 | 699 | 14.4 |
Dose | TA98 | |||||||||||
NA (-) | 10% HLI (-) | 30%HLI (-) | 10%RLI (-) | 30 % RLI(-) | ||||||||
µg/plate | MEAN | SEM | MEAN | SEM | MEAN | SEM | MEAN | SEM | MEAN | SEM | MEAN | SEM |
0.00 | 20 | 2.5 | 18 | 3.0 | 29 | 0.9 | 25 | 4.6 | 29 | 3.2 | 22 | 0.7 |
1.000 |
|
|
|
|
|
|
|
|
|
|
|
|
3.000 |
|
|
|
|
|
|
|
|
|
|
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|
10.00 |
|
|
|
|
|
|
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33.00 |
|
|
|
|
|
|
|
|
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|
100.00 | 13 | 4.1 | 14 | 1.5 | 34 | 3.5 | 40 | 7.5 | 27 | 2.7 | 23 | 3.4 |
333.00 | 20 | 2.0 | 19 | 1.7 | 32 | 1.5 | 36 | 4.9 | 33 | 7.3 | 24 | 1.2 |
1000.00 | 17 | 2.2 | 22 | 3.7 | 41 | 3.5 | 36 | 1.5 | 31 | 0.7 | 22 | 1.2 |
3333.00 | 19 | 0.0 | 20 | 3.3 | 39 | 3.2 | 39 | 3.3 | 33 | 1.5 | 23 | 2.0 |
10000.00 | 14 | 1.2 | 23 | 1.9 | 28 | 2.0 | 28 | 3.3 | 25 | 3.2 | 14 | 2.7 |
POS | 355 | 21.4 | 425 | 11.6 | 664 | 42.2 | 372 | 8.4 | 460 | 164.9 | 374 | 18.8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Gene toxicity in vitro:
Peer reviewed articles were viewed to determine the mutagenic nature of the test compound FD and C red 4 (CAS no 4548 -53 -2). The studies are summarized as below:
Genetic toxicity test was performed by Zeiger et al, 1992 for Ponceau SX on S typhimurium (Strain TA100, TA98, TA97 and TA 1535). Initial testing was in strain without activation and with 30% rat and hamster S-9. If a positive response was obtained in one or both strains, only the positive test condition was repeated. Each chemical was initially tested in the preincubation test at half-log dose intervals up to a dose that elicited toxicity, or to a dose immediately below one that was toxic in the preliminary toxicity procedure.The test chemical (0.05 ml), overnight culture of Salmonella (0.10 ml at CWR and MIC, and 0.05 ml at SRI), and S-9 mix or buffer (0.50 ml), were incubated at 37◦C, without shaking, for 20 min.At least five doses of each chemical were tested in triplicate, and repeat experiments were performed at least one week following the initial trial.A maximum of 0.05 ml solvent was added to each plate.Different concentrations used are 0, 1, 3.10, 33, 100, 333, 1000, 3333, 10000, µg/plates.The positive controls in the absence of metabolic activation were sodium azide (TA1535 and TA100), 9-aminoacridine (TA97 and TA 1537), 4-nitro-o phenylenediamine (TA98 and TA1538), mitomycin C (TA102), and methyl methane sulfonate (TA 104) and the positive control for metabolic activation with all strains was 2-aminoanthracene, and either sterigmatocystin or 2 aminoanthracene were used. A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+revertants did not meet the criteria for a “+W” response, or if only single doses produced increases in his+revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet the criteria for a mutagenic or questionable response. From the experiment onS typhimurium(Strain TA100, TA98, TA97 and TA 1535)it was concluded that thePonceau SX(CAS No 4548-53-2) was genetically non-toxic chemical with and without activation.
Genetic toxicity test was performed on Salmonella typhimurium strains (TA100, TA98) was also performed by Zeiger et al, 1992 by using FMN protocol (some modification in standard preincubation assay). In which the 30% liver S-9 was supplemented, per ml, with 0.2 M MgCL2/0.825 M KCI, 0.04 ml; 0.02 M NADH, 0.10 ml; 0.04 M NADP, 0.1 ml; 0.02 M FMN, 0.10 ml; 0.2 M glucose-6-P04, 0.10 ml; glucose-6-P04dehydrogenase,
2.8 U/0. 10 ml; and 1 .0 M NaH2PO4/K2HPO4, pH 7.4,0. 10 ml.The dye, congo red, was used as the positive control chemical.
A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+revertants did not meet the criteria for a “+W” response, or if only single doses produced increases in his+revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet the criteria for a mutagenic or questionable response. From the experiment onS typhimurium(Strain TA100, TA98)it was concluded that the Ponceau SX (CAS No 4548-53-2) was genetically non-toxic chemical with and without activation.
Salmonella-mammalian microsome mutagenicity test was performed by King-Thom (1981) on strains TA1535, TA1537, TA1538, TA98, or TA100. Two assays were performed a) plate incorporation and b) Preincubation assay.The plate incorporation assays were performed as described by Ames et al.The liquid preincubation assays were timed for 30 min at 37°C in a Dri-block.(S9) were prepared from male Sprague-Dawley rats stimulated with Aroclor 1254 (500 mg/kg intraperitoneally 5 days before sacrifice).Dimethyl sulfoxide is the solvent used.The positive control chemicals sodium azide, 9-aminoacridine, 2- nitrofluorene, and 2-aminoanthracene were used with the tester strains. The dose-response curves for the mutagenic compounds used the tester strain which showed maximum mutagenicity and covered a range of 1 to 1,000 or 5 to 5,000 µg. From the experiment it was found that the maximum non-toxic dose for plate incorporation was found to be 5000 µg and for liquid preincubation assay was found to be 500 µg. Therefore,genetic toxicity for the Salmonella-mammalian microsome mutagenicity test was found to be negative (with and without S9 activation) on using Ponceau SX (CAS no 4548-53-2).
The in vitro genetic toxicity test was performed by Kornburst (1985) on rat hepatocytes with following concentrations (1X 10-3, 1X10-4, 1X10-5,and 2X 10-6). Rat hepatocytes were isolated and cultured by the two-step in situ liver perfusion method.2 X 105 viable hepatocytes were seeded into 25-mm wells and were allowed to attach to plastic cover slips for 2 hr. The cells were then incubated for 4 hr with [3H]-thymidine. Net nuclear grains (NNG) were determined by counting the number of grains in each nuclei and subtracting the average number of grains present in three equal-size adjacent cytoplasmic areas. Therefore, the genetic toxicity for In Vitro Rat Hepatocyte Primary Culture/ DNA Repair Assays test was found to be negative by using Food red 1 (CAS no 4548-53-2).
Genetic toxicity test were performed by Price et al (1978) on 500 Fisher rat embryo cells with different concentrations of dyes as0.1, 1,10,100,1000 µg ml. The rat cells were plated on medium without food colourings and incubate at 37◦C in humidified 5% CO2, in air for 2 h. The medium was then decanted and replaced by a medium containing the test dyes at the various dilutions (three plates per dilution). After 48 h the medium was replaced with a freshly prepared medium. The dishes were fixed and stained on day 5 and toxicity was determined by reduction in cloning efficiency relative to a control medium and maximum non-toxic dose were determined. From the study it was found that the genetic toxicity result on the bases of maximum non-toxic dose (MND) was found to be positive for FD&C Red No. 4 (4548-53-2) at 10 µg per ml.
Based on the majority of studies reviewed, the test material Ponceau SX is not mutagenic in vitro.
Justification for selection of genetic toxicity endpoint
The test compound Ponceau SX is not mutagenic in the in vitro test performed with and without metabolic activation system.
Justification for classification or non-classification
Gene toxicity in vitro:
Based on the key study used and its relative supporting data, the test material Ponceau SX is not mutagenic in vitro.
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