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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from opinion document of European Food Safety Authority
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food
- Author:
- European Food Safety Authority
- Year:
- 2 007
- Bibliographic source:
- The EFSA Journal (2007) 515, 1-28
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Details of the guidelines are not mentioned in the publication
- GLP compliance:
- not specified
Test material
- 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
- Reference substance name:
- Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphtalene-3,6-disulphonate
- IUPAC Name:
- Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphtalene-3,6-disulphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Cas No: 3734-67-6Chemical Name: Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphtalene-3,6-disulphonate (Synonym: Red 2G)Nature of the chemical: Organic
Constituent 1
Constituent 2
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 250 mg/kg bw Red 2G was administered to male and female rats by gastric intubation
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- 250 mg/kg bw Red 2G was administered to male and female rats by gastric intubation
- Duration and frequency of treatment / exposure:
- 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:250 mg/kg bw
- No. of animals per sex per dose / concentration:
- No data
- Control animals:
- not specified
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Absorption is expected to take place in the gastro-intestinal tract
- Type:
- distribution
- Results:
- No data
- Type:
- metabolism
- Results:
- Pre-systemic and systemic azo-reduction yields 2-amino-8-acetamido-1-naphto-3,6- disulphonic acid and aniline. Aniline is further oxidized to p-aminophenol and o-aminophenol.
- Type:
- excretion
- Results:
- Based on excretion of Red 2G metabolites in bile and urine, at least 50-70% of the dose is reduced at the azo-bridge. In urine and faeces of rats less than 5% of unchanged Red 2G could be detected.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- 2-amino-8-acetamido-1-naphto-3,6- disulphonic acid & aniline. Aniline is further oxidized to p-aminophenol and o-aminophenol
Any other information on results incl. tables
Metabolism: Pre-systemic and systemic azo-reduction yields 2-amino-8-acetamido-1-naphto-3,6-disulphonic acid and aniline. Aniline is further oxidized to p-aminophenol and o-aminophenol. p-Aminophenol (free and conjugated) was quantitatively the most important metabolite in urine following administration of Red 2G
Excretion: Based on excretion of Red 2G metabolites in bile and urine, at least 50-70% of the dose is reduced at the azo-bridge. In urine and faeces of rats less than 5% of unchanged Red 2G could be detected. Urinary excretion of the aniline moiety takes place mainly in the form of aminophenols (in total 42-56% of the dose). Faecal excretion of these products was also observed although to a lesser degree than in urine.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study resultsDisodium 8-acetamido-1-hydroxy-2-phenylazo-naphtalene-3,6-disulphonate (Synonym: Red 2G) is known to be metabolized in male and female rats which were administered the chemical by gavage and excreted out of the living system through the urine and a minor amount in feaces. Urinary excretion of the aniline moiety takes place mainly in the form of aminophenols (in total 42-56% of the dose). Faecal excretion of these products was also observed although to a lesser degree than in urine. Thus, considering the quick time (48 hours) in which more than half of the administered dose of the chemical is excreted out of the body of rats, bio-accumulation potential is expected to be low.
- Executive summary:
Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphtalene-3,6-disulphonate (Synonym: Red 2G) is known to be metabolized in male and female rats and excreted out of the living system through the urine and a minor amount in feaces. In 48 hours in males and females 42.2% and 56.4% of the dose was excreted as p-aminophenol. In 24 hours in males and females 3% and 2.6% of the dose was excreted as unreduced dye. Thus, considering the quick time in which more than half of the administered dose of the chemical is excreted out of the body of rats, bio-accumulation potential is expected to be low. However, the EFSA panel concluded that it would be prudent to regard Red 2G as being of safety concern since it is extensively metabolized to aniline.
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