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Diss Factsheets
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EC number: 202-947-7 | CAS number: 101-50-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro study of DNA damage induced by acid orange 52 and its biodegradation derivatives
- Author:
- HEDI BEN MANSOUR,†‡ DANIEL BARILLIER,† DAVID CORROLER,† KAMEL GHEDIRA,‡ LEILA CHEKIR-GHEDIRA, *‡§ and RIDHA MOSRATI†
- Year:
- 2 009
- Bibliographic source:
- Environmental Toxicology and Chemistry, Vol. 28, No. 3, pp. 489–495, 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- In vitro gene toxicity study of acid orange 52 (AO52) in Salmonella Typhimurium TA102 and TA104
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Sodium 4-(4-dimethylaminophenylazo)benzenesulphonate
- EC Number:
- 208-925-3
- EC Name:
- Sodium 4-(4-dimethylaminophenylazo)benzenesulphonate
- Cas Number:
- 547-58-0
- IUPAC Name:
- sodium 4-{[4-(dimethylamino)phenyl]diazenyl}benzenesulfonate
- Reference substance name:
- Acid orange 52
- IUPAC Name:
- Acid orange 52
- Details on test material:
- - Name of test material (as cited in study report): Acid orange 52 (AO52) - Molecular formula (if other than submission substance): C14-H15-N3-O3-S.Na- Molecular weight (if other than submission substance): 327.3386 g/mole - Substance type: Organic - Physical state: No data available Purity: No data available - Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
Method
- Target gene:
- No data
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA102 and TA104
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254
- Test concentrations with justification for top dose:
- 250, 50, and 10 g/plate
- Vehicle / solvent:
- No data available
Controls
- Untreated negative controls:
- yes
- Remarks:
- spontaneous revertants.
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: With S9 - 5 g/plate of 2-AA Without S9 - 86.5 μg/plate of methyl methane Sulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period: 45 min- Exposure duration: 48 h- Expression time (cells in growth medium): 16 h- 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: 2 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: An overnight culture of bacteria (100 μl, cultivated for 16 h at 37°C, approximate cell density 2 X 108 cells/ml) and sodium phosphate buffer (500 μl, 0.2 M, pH 7.4, for assay without metabolic activation system) or S9 mix (500 μl) were distributed in sterilized capped tubes in an ice bath, then 100 μl of test concentration 250, 50, and 10 g/plate was added.
- Evaluation criteria:
- Revertant bacterial colonies were examined.
- Statistics:
- Mutagenic effect data are expressed as mean ± standard deviation from three replicates. The statistical analyses were performed with Statistica ’99 Edition (Stat Soft France, Maisons- Alfort, France). The Duncan test was used to compare test compounds with the negative control (spontaneous revertants), and the difference was considered to be significant at p < 0.05.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA104
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No data
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Mutagenic activity of AO52 (after static or shaken degradation with Pseudomonas putida mt-2), 4-ABS, and DMPD evaluated by the Salmonella Typhimurium TA104 and TA102 assay systems with and without the metabolic activation system (S9)
|
| Mutagenic activity (revertants/plates)b | |||
|
| TA104 | TA102 | ||
Tested compounda | Dose (μg/plate) | -S9 | +S9 | -S9 | +S9 |
PC | — | 1,846 ± 46*** | 1,400 ± 53*** | 1,721 ± 24*** | 1,031 ± 231*** |
SP | — | 203 ± 11 | 273 ± 14 | 175 ± 10 | 217 ± 14 |
Pure AO52 | 250 | 221 ± 09 | 755 ± 24** | 254 ± 09 | 639 ± 21** |
| 50 | 198 ± 08 | 555 ± 25 | 222 ± 08 | 544 ± 19 |
| 10 | 197 ± 04 | 382 ± 23 | 213 ± 11 | 311 ± 14 |
a4-ABS = 4-aminobenzenesulfonic acid; AO52 = acid orange 52; DMPD = N,N’-dimethyl-p-phenylenediamine; PC = positive control; PPD = p-phenylenediamine; SP = spontaneous revertants.
bTA102/–S9 and TA104/–S9 = methyl methane sulfonate (86.5 μg/plate); TA102/+S9 and TA104/+S9 =2-aminoanthracene (5 μg/plate).
Values are significant at * p < 0.01, ** p < 0.001, and *** p < 0.0001.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative without metabolic activationpositive with metabolic activationAcid orange 52 (AO52) was considered to be negative without S9 and positive gene toxic with S9 metabolic activation when Salmonella Typhimurium TA102 and TA104 tested.
- Executive summary:
In a in vitro gene mutation test, Salmonella Typhimurium TA102 and TA104 was tested for Revertant bacterial colonies by using Acid orange 52 (AO52) with and without S9 activation in the concentration of 250, 50 and 10 g/plate. Revertant bacterial colonies were not observed in without S9 activation and with S9 metabolic activation revertant bacterial colonies were observed. Therefore, Acid orange 52 (AO52) was considered to be negative without S9 and positive gene toxic with S9 metabolic activation when Salmonella Typhimurium TA102 and TA104 were tested.
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