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Diss Factsheets
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EC number: 700-502-6 | CAS number: -
- 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
- Study period:
- from 2008-05-14 to 2008-07-03
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- not applicable
Method
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA 1535, TA 100) and frameshift (TA 1537, TA 98) mutations. The Escherichia coli WP2 uvrA (trp) reversion system measures trp– trp+ reversions. The Escherichia coli WP2 uvrA detect mutagens that cause other base-pair substitutions (AT to GC).
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with
- Metabolic activation system:
- 2-Aminoanthracene, 2AA
- Test concentrations with justification for top dose:
- The examined concentration levels were different at each examined bacterium strain. The maximum test concentration was 5000 or 2000 μg/plate in case of Salmonella typhimurium strains (depending on the test method and on the presence or absence of metabolic activation) and 5000 μg/plate in case of Escherichia coli WP2 uvrA:
- Initial Mutation Test (Plate Incorporation Test): 2000; 632.5; 200; 63.25; 20; 6.325 and 2 µg/plate (S. typhimurium strains) and 5000; 1581.1; 500; 158.1; 50; 15.81 and 5 μg/plate (E. coli WP2 uvrA).
- Complementary Plate Incorporation Test in S.typhimurium TA 100: 2; 0.633; 0.2 μg/plate (–S9 Mix); 5000 and 2000 μg/plate (+S9 Mix); in TA 1535: 5000 and 2000 μg/plate (±S9 Mix) and in TA 1537: 2 and 0.633 μg/plate (±S9 Mix).
- Confirmatory Mutation Test (Pre-Incubation Test) the examined concentration levels were in case of S.typhimurium TA 98 and TA 1535: 2000; 632.5; 200; 63.25; 20; 6.325; 2 and 0.633 μg/plate; in case of TA 100 and TA 1537: 200; 63.25; 20; 6.325; 2; 0.633 and 0.2 μg/plate. In case of E. coli WP2 uvrA the 5000; 1581.1; 500; 158.1; 50; 15.81 and 5 μg/plate concentration levels were tested.
- Complementary Pre-Incubation Test the examined concentration levels were in case of S.typhimurium TA 98 and TA 1535: 5000 and 2000 μg/plate (±S9 Mix) and in TA 100 and TA 1537: 2000; 632.5 and 200 μg/plate (±S9 Mix). - Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Details on test system and experimental conditions:
- see attachment for details
- Evaluation criteria:
- The colony numbers for control, positive control and the test plates were determined, the mean values and appropriate standard deviations were calculated. The mutation factor (MF) was calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (exact, not rounded values were used for this calculation).
- Statistics:
- not applicable
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- not applicable
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
no remarks
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
F 213 Red is considered as non mutagenic. - Executive summary:
The reported data of this mutagenicity assay shows, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the strains used. Therefore, F 213 Red is considered non-mutagenic in this bacterial reverse mutation assay.
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