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Diss Factsheets
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EC number: 239-888-1 | CAS number: 15790-07-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15985:1.
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- 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:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the Genotoxic effect of Sunset Yellow in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- EC Number:
- 220-491-7
- EC Name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 2783-94-0
- Molecular formula:
- C16H12N2O7S2.2Na
- IUPAC Name:
- disodium (5E)-6-oxo-5-[(4-sulfonatophenyl)hydrazinylidene]naphthalene-2-sulfonate
- Test material form:
- solid
- Details on test material:
- - Name of test material: disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Molecular formula: C16H12N2O7S2.2Na
- Molecular weight: 454.38
- Substance type: organic
- Physical state: solid
-Purity : 91%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):sunset yellow
- Molecular formula (if other than submission substance):C16H12N2O7S2.2Na
- Molecular weight (if other than submission substance):452.37 g/mol
- Substance type;Organic
- Physical state:solid
-Purity;91%
Method
- Target gene:
- no data
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538, and TA98.
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- The mammalian liver homogenate fraction "S-9" was prepared from female Sprague Dawley rats were injected i.p. with about 0.5 ml of a corn oil solution of Aroclor 1254
- Test concentrations with justification for top dose:
- 50 and 250 µg/plate
- Vehicle / solvent:
- Vehicle
- Vehicle(s)/solvent(s) used: water or DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Ethylmethanesulfonate (5 µl) Methylmethanesulfonate (1 µl) 9-Aminoaeridine (50µl) Nitroquinoline-N-oxide (0.22 pg) Anthragallol ( 50 µ g ) 2-Anthramine (1 µg) Negative control Dithionite
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period:16 hour
- Exposure duration:3 days
- Expression time (cells in growth medium): 3days
OTHER: Liquid test was also performed . - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls.
- Statistics:
- Mean was observed.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538, and TA98.
- 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
- Remarks on result:
- other: No mutagenic effect were observed
Any other information on results incl. tables
SCREENING OF CERTIFIED FOOD COLORS AND RELATED COMPOUNDS WITH THE SALMONELLA/MICROSOME TEST SYSTEM; AZO DERIVATIVES TESTED BEFORE AND AFTER CHEMICAL REDUCTION TO COMPONENTAMINES- by plate method
a Compounds tested that are considered to be mutagenic (+) or probably mutagenic (?+). b Chemical reduction of azo compounds with Na2S204 immediately prior to plating. c Activation with "S-9 mix" rat liver micro some preparations from animals induced with Aroclor 1254. d Tester strains exhibiting a mutagenic response on treatment with the test agent: 5, TA1535; 0, TA100; 7, TA1537, 8, TA1538; 9, TA98. e Estimated revertants/nmol test agent for strain showing greatest activity (in parentheses). f Mutagenic response in terms of h/s + r e v e r t a n t s / p l a t e less control for indicated exposure in ~g, also for strain in parentheses. * Separate experiment with TA98 only. t Activity with TA100 obtained with ATP (ca. 3.5 mg/ml liquid test mixture). * Aerobic liquid test.
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Applicant's summary and conclusion
- Conclusions:
- The result was considered to be negative (with and without) for Sunset Yellow(2783-94-0) in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.
- Executive summary:
Genotoxic study was observed for Sunset Yellow in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.The Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 were exposed at the concentration of 50 and 250µg /plate with and without S9. The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. The azo dye Yellow No.6 was plated in the usual fashion at concentrations from 50 pg/plate to 500 pg/plate and then were incubated anaerobically for 16 h before the usual 3-day aerobic incubation. All results with the five tester strains with and without microsomal activation were negative. Therefore the result was considered to be negative (with and without) for Sunset Yellow in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method. Hence the substance cannot be classified as gene mutant in vitro.
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