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EC number: 227-497-9 | CAS number: 5858-81-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation toxicity study was performed by F. RAFII et al. (Food and Chemical Toxicology, 1997) to determine the mutagenic nature of D&C Red 6 by bacterial reverse mutation assay. D&C Red No. 6 (5858-81-1) was assessed for its possible mutagenic potential. For this purpose AMES assay was performed on Salmonella typhimurium TA98 and TA100. The test material was exposed at the concentration of50-200 µg/plate in the presence and absence of S9. No mutagenic effects were observed. Therefore D&C Red No. 6 was considered to be non mutagenic in the Salmonella typhimurium TA98 and TA100 by AMES test. Hence the substance cannot be classified as genetox in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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.
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of D&C Red No. 6 in Salmonella typhimurium TA98 and TA100 by AMES test.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Name of the test chemical: disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylateCommon Name used in study : D&C Red 6Molecular Formula: C18H12N2Na2O6SMolecular Weight: 430.3468 g/molInChI: 1S/C18H14N2O6S.2Na/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);;/q;2*+1/p-2/b20-19+;;Substance Type: OrganicPhysical State: Solid
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- 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 S-9 fraction (Organon Teknika, Durham, NC, USA) was from Sprague-Dawley rats induced with Aroclor-1254.
- Test concentrations with justification for top dose:
- 0,50-200 µg/plate
- Vehicle / solvent:
- Vehicle- Vehicle(s)/solvent(s) used: Water
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: DMSO, 1,6-dinitropyrene and benzo[a]pyrene
- Details on test system and experimental conditions:
- Details on test system and conditionsMETHOD OF APPLICATION: Plate incorporation method
- Rationale for test conditions:
- Not specified.
- Evaluation criteria:
- A positive result in the Ames test, which is defined as a reproducible, dose-related, at least twofold increase in the number of revertants over background was not observed with any of the azo dyes or their metabolites either before or after incubation with S-9.
- Statistics:
- Standard deviation was observed.
- Key result
- Species / strain:
- S. typhimurium, other: TA98 and TA100.
- 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.
- Conclusions:
- D&C Red No. 6 (5858-81-1) was evaluated for its mutagenic potential in Salmonella typhimurium TA98 and TA100 by AMES test. The test result was considered to be negative in the presence and absence of metabolic activation.
- Executive summary:
D&C Red No. 6 (5858-81-1) was assessed for its possible mutagenic potential. For this purpose AMES assay was performed on Salmonella typhimurium TA98 and TA100. The test material was exposed at the concentration of50-200 µg/plate in the presence and absence of S9. No mutagenic effects were observed. Therefore D&C Red No. 6 was considered to be non mutagenic in the Salmonella typhimurium TA98 and TA100 by AMES test. Hence the substance cannot be classified as genetox in vitro.
Reference
Table 1. Number of revertants of Salmonella typhimurium TAI00 with various azo dyes in the presence and absence of S-9 fraction
| Dye without S-9 | Dye with S-9 | ||
50 µg | 200 µg | 50 µg | 200 µg | |
D&C Red No. 6 | 185 ± 15 | 111 ± 14 | 156 ± 8 | 127 ± 5 |
a300 lag of dye was used.bNot applicable.C5 lag/plate of 1,6-dinitropyrene or benzo[a]pyrene was used.
Table 2. Number of revertants of Salmonella typhimurium TA98 with various azo dyes in the presence and absence of S-9 fraction
| Dye without S-9 | Dye with S-9 | ||
50 µg | 200 µg | 50 µg | 200 µg | |
D&CRedNo. 6 | 33±4 | 34±8 | 27±11 | 17±4 |
aNot applicable.b5 lag/plate of 1,6-dinitropyrene or benzo[a]pyrene was used.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genotoxicity In-vitro
Various publications were reviewed to determine the mutagenic nature of disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate /(5858-81-1) Other name: D&C Red 6 and Lithol rubine B(R201). The studies are as mentioned below:
Gene mutation toxicity study was performed by F. RAFII et al. (Food and Chemical Toxicology, 1997) to determine the mutagenic nature of D&C Red 6 by bacterial reverse mutation assay. D&C Red No. 6 (5858-81-1) was assessed for its possible mutagenic potential. For this purpose AMES assay was performed on Salmonella typhimurium TA98 and TA100. The test material was exposed at the concentration of50-200 µg/plate in the presence and absence of S9. No mutagenic effects were observed. Therefore D&C Red No. 6 was considered to be non mutagenic in the Salmonella typhimurium TA98 and TA100 by AMES test. Hence the substance cannot be classified as genetox in vitro.
Supported by a experimental study which is performed by J.P. BROWN et al. (Mutation Research, 1979) to determine the mutagenic nature of D&C Red 6. D and C Red No. 6 was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98. The test material was exposed at the concentration of 0, 50,100and 500µg/plate in the presence and absence of S9 mix. Number of HIS + Revertants/plate was observed for test substance and compared with positive and negative control. No mutagenic effect were observed in any of the strain ,both in the presence and absence of S9.Therefore D and C Red No. 6 was considered to be non mutagenic in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 by bacterial reverse mutation assay. Hence the substance cannot be classified as gene mutant in vitro.
Another supporting study conducted by JEANNE M. MUZZALLet al. (Mutation Research, 1979) to determine the mutagenic nature of D&C Red 6(5858-81-1).D and C Red No. 6 was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA1535, TA100, TA1537and TA98. The test material was exposed at the concentration of 0, 10-250 mg in the presence and absence of S9 mix. Number of HIS + Revertants/plate was observed for test substance and compared with negative control. No mutagenic effect were observed in any of the strain ,both in the presence and absence of S9.Therefore D and C Red No. 6 was considered to be non mutagenic in Salmonella typhimurium strains TA1535, TA100, TA1537 and TA98 by bacterial reverse mutation assay. Hence the substance cannot be classified as gene mutant in vitro.
It is further supported by experimental study conducted by MIYAGOSHI M et al. (EISEI KAGAKU (J HYG CHEM), 1983) to determine the mutagenic nature of Lithol rubine B(R201) CAS NO; 5858-81-1. Lithol rubine B(R201)f was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA 100 and TA98. The test material was exposed at the concentration of 0, 50,100, 500 and 1000µg/plate in the presence and absence of S9 mix. Number of HIS + Revertants/plate was observed for test substance and compared with positive and negative control. No mutagenic effect were observed in any of the strain ,both in the presence and absence of S9.Therefore Lithol rubine B(R201)was considered to be non mutagenic in Salmonella typhimurium strains TA 100and TA98 by bacterial reverse mutation assay. Hence the substance cannot be classified as gene mutant in vitro.
Based on the data available for the target chemical disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate /(5858-81-1) Other name: D&C Red 6 and Lithol rubine B(R201) does not induce gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria for the target chemical .Disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate /(5858-81-1) Other name: D&C Red 6 and Lithol rubine B(R201) does not induce gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
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