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EC number: 247-368-0 | CAS number: 25956-17-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicity study of the given test chemical in Sprague-Dawley rats
- Author:
- Borzelleca et al.
- Year:
- 1 989
- Bibliographic source:
- Food and Chemical Toxicology
- Reference Type:
- publication
- Title:
- WHO Food Additives Series
- Author:
- WHO
- Year:
- 2 017
- Bibliographic source:
- World Health Organization
- Reference Type:
- publication
- Title:
- Toxicological Evaluation of Certain Food Additives
- Author:
- WHO
- Year:
- 1 980
- Bibliographic source:
- WHO
- Reference Type:
- review article or handbook
- Title:
- Acute oral toxicity of test chemical
- Author:
- Richard J. Lewis
- Year:
- 2 012
- Bibliographic source:
- Sax's Dangerous Properties of Industrial Materials
- Reference Type:
- other: authoritative database
- Title:
- Acute oral toxicity by using test chemical
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- ChemIDplus
- Reference Type:
- other: authoritative database
- Title:
- Acute studies in rodents.
- Author:
- U.S. National Library of Medicine
- Year:
- 2 012
- Bibliographic source:
- HSDB
- Reference Type:
- other: secondary database
- Title:
- Robust Summaries and Test Plans
- Author:
- USEPA
- Year:
- 2 006
- Bibliographic source:
- HPV Challenge Program
- Reference Type:
- secondary source
- Title:
- Evaluation of the test chemical
- Author:
- EFSA
- Year:
- 2 009
- Bibliographic source:
- EFSA Journal
- Reference Type:
- publication
- Title:
- Acute oral toxicity of test chemical in rats
- Author:
- HPVIS
- Year:
- 2 018
- Bibliographic source:
- HPVIS,2018
- Reference Type:
- other: secondary source
- Title:
- OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS – Curry Red (Colipa n C174).
- Author:
- European Commission (EC) - Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP)
- Year:
- 2 004
- Bibliographic source:
- SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS – SCCP, Colipa n C174, SCCNFP/0791/04, 2004.
- Reference Type:
- other: secondary database
- Title:
- Toxicological Profiles - Test chemical
- Author:
- U.S. Consumer Product Safety Commission
- Year:
- 1 981
- Bibliographic source:
- NATIONAL TECHNICAL INFORMATION SERVICE
- Reference Type:
- other: secondary source
- Title:
- Acute oral toxicity
- Author:
- European Commission (EC) - Scientific Committee on Cosmetology (SCC)
- Year:
- 1 987
- Bibliographic source:
- European Commission (EC) - Scientific Committee on Cosmetology (SCC),1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of the given test chemical was performed in rat.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Details on test material:
- - IUPAC Name: Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Common Name: Allura Red AC
- InChI: 1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);; /q;2*+1/p-2/b20-19+;;
- Smiles: c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N =N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O. [Na+].[Na+]
- Molecular formula:C18H14N2Na2O8S2
- Molecular weight :496.4266 g/mole
- Substance type:organic
- Physical state:Solid, dark red in color
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: The animals were fasted for 3-4 hours prior to dosing.
- Housing: Following dosing, the animals were housed in metal cages suspended above the droppings.
- Diet (e.g. ad libitum): Food, ad libitum.
- Water (e.g. ad libitum): Water, ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% W/V solution - Doses:
- 215, 464, 1000, 2150, 4640, and 10000 mg/kg bw
- No. of animals per sex per dose:
- Six groups of five male and five female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days.
- Necropsy of survivors performed: yes, following the observation period, the animals were weighed, sacrificed by cerebral concussion and necropsied. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths at any dose level tested.
- Clinical signs:
- other: Clinical observations were normal with the exception of red colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals.
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute oral toxicity dose (LD50) value was considered to be >10000 mg/kg bw, when male and female Sprague-Dawley albino rats were treated with the given test chemical via oral gavage route.
- Executive summary:
Acute oral toxicity study was conducted by using the given test chemical in male and female Sprague-Dawley albino rats at the dose concentrations of 215, 464, 1000, 2150, 4640, and 10000 mg/kg bw. Six groups of five male and five female Sprague-Dawley rats each were administered the test substance in a 10% weight/volume solution. The animals were fasted for 3-4 hours prior to dosing. Following dosing, the animals were housed in metal cages suspended above the droppings. Food and water were available ad libitum. Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days. Following the observation period, the animals were weighed, sacrificed by cerebral concussion and necropsied. There were no deaths at any dose level tested. Clinical observations were normal with the exception of red colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals. Under the condition of the study, the LD50 value was considered to be >10000 mg/kg bw, when male and female Sprague-Dawley albino rats were treated with the given test chemical via oral gavage route.
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