Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 223-098-9 | CAS number: 3734-67-6
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Methodology for the testing of food dyes for genotoxic activity: experiments with RED 2G (C.I. 18050)
- Author:
- R.B. Haveland-Smith, R.D. Combes, B.A. Bridges
- Year:
- 1 979
- Bibliographic source:
- Mutation Research, 64 , 241—248
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The mutagenicity of Red 2G was evaluated in Salmonella typhimurium strain TA1538 by Fluctuation tests.
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Red 2G
- IUPAC Name:
- Red 2G
- Reference substance name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 223-098-9
- EC Name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3734-67-6
- Molecular formula:
- C18H15N3O8S2.2Na
- IUPAC Name:
- disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Red 2G- Molecular formula (if other than submission substance): C18-H15-N3-O8-S2.2Na- Molecular weight (if other than submission substance): 509.426 g/mol - Substance type: Organic - Physical state: Aqueous solutions or suspensionsPurity- 80%- Impurities (identity and concentrations): As, Pb ,Sb, BaSO4, Cr, Cu, Zn,Free aromatic amines, Synthetic intermediates (excluding free aromatic amines),Subsidiary colures were present.
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Calcium precipitated microsome from rat liver (Male, 5-week old Sprague-Dawley rats were supplied with 0.1% w/v sodium pentobarbitone and 2% w/v D-glucose in their drinking water for one week.)
- Test concentrations with justification for top dose:
- Fluctuation tests without microsomal activation: 10 mg/ ml Fluctuation tests with microsomal activation: 10 mg /ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Deionised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Rimmel Mahogany Silk 2-acetylaminofluorene
- Details on test system and experimental conditions:
- Fluctuation test without microsomal activationThe fluctuation test was performed according to the method of Green and Muriel with the following modifications. A single colony from a plate of each of the bacterial strains (S. typhimurium TA1538) was inoculated into 10 ml of the appropriate growth medium and incubated overnight at 37°C with shaking. The mutation media were as follows: (a) TA1538: solution SA, 1.20.5 ml; solution SB, 4.5 ml; solution SC, 25 pl; solution SD, 25 pl. Sub-lethal concentrations of each test agent were prepared in the mutation media. 30 µl of inoculum culture were pipetted into this mixture, which was then dispensed in 2-ml aliquots into 50 test tubes (75 × 12 mm, rimless). The number of turbid tubes was scored after 72 h incubation at 37 ° C.Fluctuation test with microsomal activation0.1 ml of overnight TA1538 culture was pipetted into 0.9 ml solution SA (plus 9 mg /m1 D-glucose, 17 µg /ml L-histidine and 0.9 µg /ml D-biotin). The mutation media were as follows: (a) WP2uvrA: solution F (plus D-glucose, L-tryptophan and bacteria), 1 ml; calcium-precipitated microsome, 1 ml; 8 mg/ ml G-6-P, 0.25 ml; 5 units /ml G-6-PDH, 0.1 ml; water or water soluble test agent, 0.5 ml; (b) TA1538: as Green et al. (DMSO-soluble agents were added to the mutation media in 5-pl volumes).The mixture was dispensed in 100-µl aliquots into each of 50 test tubes and incubated for 24 h at 37°C. 2 ml solution F (plus 0.4% w/v D-glucose) was dispensed into each of the TA1538 tubes. These were then incubated for 72 hour at 37°C before scoring for turbidity.
- Evaluation criteria:
- The tubes were scored for turbidity.
- Statistics:
- No data available.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negativeRed 2G was determined to give negative results for mutagenicity in Salmonella typhimurium strain TA1538 in Fluctuation tests conducted with and without metabolic activation at the concentration of 10mg /ml.
- Executive summary:
Genotoxicity study for Red 2G was conducted in Salmonella typhimurium strain TA1538 at the concentration of 10mg /ml in presence and absence of metabolic activation by Fluctuation tests.
The tubes were scored for turbidity. When dyes such as Red 2G was used in this system, it may be impossible to detect the turbidity in the tubes by eye or to use a growth indicator such as bromothymol blue, due to masking by the colour. In this case, the presence of viable prototrophic revertants was verified by streaking loopfuls from each tube onto unsupplemented agar.
No significant change was observed in the tubes. Therefore Red 2G was determined to give negative results for mutagenicity in Salmonella typhimurium strain TA1538 in Fluctuation tests conducted with and without metabolic activation at the concentration of 10mg /ml.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.