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EC number: 248-895-9 | CAS number: 28198-05-2
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity Testing of Certified Food Colors and Related Azo, Xanthene And Triphenylmethane Dyes with the Salmonella/Microsome System
- Author:
- Joseph P. Brown, Gerald W. Roehm and Ronald J. Brown
- Year:
- 1 978
- Bibliographic source:
- Mutation Research, 56 (1978) 249-271
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:
- Gene mutation by the spot assay was performed for Sudan IV to evalute its mitagenic potential.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol
- EC Number:
- 201-635-8
- EC Name:
- 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol
- Cas Number:
- 85-83-6
- Molecular formula:
- C24H20N4O
- IUPAC Name:
- 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol / 85-83-6 / 201-635-8
- Details on test material:
- - Name of test material:C.I. Solvent Red 24
- Molecular formula :C24H20N40
- Molecular weight :380.48 g/mole
- Smiles notation: c12c(\N=N\c3c(cc(\N=N\c4c(cccc4)C)cc3)C)c(ccc1cccc2)O
- InChl: 1S/C24H20N4O/c1-16-7-3-6-10-21(16)26-25-19-12-13-22(17(2)15-19)27-28-24-20-9-5-4-8-18(20)11-14-23(24)29/h3-15,29H,1-2H3/b26-25+,28-27+
- Substance type:Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Sudan IV
- Molecular formula: C24H20N4O
- Molecular weight: 380.449 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data
- Smiles: c12c(\N=N\c3c(cc(\N=N\c4c(cccc4)C)cc3)C)c(ccc1cccc2)O
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA100, TA98, TA1535, TA1537 and TA1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolic activation system isolated female Sprague Dawley rats given ip injection of Aroclor 1254 dissolved in corn oil
- Test concentrations with justification for top dose:
- 200 µg/Plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test chemical was soluble in DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- ethylmethanesulphonate
- methylmethanesulfonate
- other: Anthragallol, 2-anthramine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Spot test
DURATION
- Preincubation period: No data
- Exposure duration: 72 hrs
- Expression time (cells in growth medium): 72 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: No data
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- The criteria adopted for scoring a mutagenic response in routine plate tests was that the observed number of revertants should exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls.
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA100, TA98, TA1535, TA1537 and TA1538
- 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:
- valid
- Remarks on result:
- other: No mutagenic effect were observed.
Any other information on results incl. tables
Table: Screening of Sudan IV
Test concentration |
Chemical reduction (dithionite) |
Microsome activation |
Number of His+revertants/plate |
||||
TA1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
|||
200µg/plate |
- |
- |
- |
- |
- |
- |
- |
|
|
+ |
- |
- |
- |
- |
- |
Applicant's summary and conclusion
- Conclusions:
- Sudan IV failed to induce mutation in Salmonella typhimurium strain TA100, TA98, TA1535, TA1537 and TA1538 with and without S9 metabolic activation system in the spot test performed and hence is not likely to classify for gene mutation in vitro.
- Executive summary:
Gene mutation by the spot assay was performed for Sudan IV. Sudan IV was used at dose level of 200 µg/plate both with and without S9 metabolic activation system. The plates were incubated for 3 days at 37°C for the growth of colonies to occur. The plates were observed for an increase in the number of His+ revertants. The criteria adopted for scoring a mutagenic response in routine plate tests was that the observed number of revertants should exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. Concurrent positive control was also included in the study.Sudan IV failed to induce mutation in Salmonellatyphimurium strain TA100, TA98, TA1535, TA1537 and TA1538 with and without S9 metabolic activation system in the spot test performed and hence is not likely to classify for gene mutation in vitro.
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