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Diss Factsheets
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EC number: 222-657-4 | CAS number: 3567-69-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- The Metabolic Disposition of 14C-Labelled Carmoisine in the Rat after Oral and Intravenous Administration
- Author:
- C. L. Galli, M. Marinovich and L. G. Costa
- Year:
- 1 982
- Bibliographic source:
- Fd Chem. Toxic. Vol. 20. pp. 351 to 356, 1982
Materials and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate
- EC Number:
- 222-657-4
- EC Name:
- Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate
- Cas Number:
- 3567-69-9
- Molecular formula:
- C20H12N2Na2O7S2
- IUPAC Name:
- disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate
- Details on test material:
- SOURCE OF TEST MATERIAL
- Source of test material: Sustainability Support Services (Europe) AB, Sweden
- Lot/batch No.of test material: 0015
- Expiration date of the lot/batch: 13 Feb.; 2021
- Purity test date: No data
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: No data
- Specific activity: No data
- Locations of the label: No data
- Expiration date of radiochemical substance: No data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient Temperature
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item was moistened with distilled water before application.
- Preliminary purification step (if any):No data
- Final dilution of a dissolved solid, stock liquid or gel: No data
- Final preparation of a solid: No data
FORM AS APPLIED IN THE TEST (if different from that of starting material) No data
OTHER SPECIFICS:
Safety Precautions: Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses).
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Inc., Calco, Como
- Age at study initiation: No data available
- Weight at study initiation: 150-200 g
- Fasting period before study: 12 hrs
- Housing: The animals were housed individually in metabolic cages
- Diet (e.g. ad libitum): free access to a standard diet (4 RF 21, from Charles River Inc.)
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: Drinking water
- Details on exposure:
- Each rat was dosed with [14C]carmoisine either orally (200 mg/kg body weight; 25 µCi), the dye being dissolved in distilled water to a final volume of 0.3mL
- Duration and frequency of treatment / exposure:
- 5 min
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200 mg/Kg bw
- No. of animals per sex per dose / concentration:
- No data available
- Control animals:
- not specified
Results and discussion
- Preliminary studies:
- Levels of 14C activity in the samples were determined with a Packard Tri-Carb 3255 scintillation counter.
Main ADME resultsopen allclose all
- Type:
- absorption
- Type:
- distribution
- Type:
- excretion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Within 5 min of oral administration of the dye, the
blood levels of radioactivity were significantly higher than the blank values, indicating a rapid absorption of carmoisine. The highest level of radioactivity, corresponding to 0.01 % of the orally administered dose per ml of blood, was reached within 10 min and then slowly declined, no 14C activity being detected at 32hr. - Details on distribution in tissues:
- Radioactivity was not detected in the brain after any interval, indicating that neither the azo dye nor its metabolites crossed the blood-brain barrier. Among the other tissues analysed, the lungs, testes, spleen, epididymal adipose tissue and muscle showed no levels of radioactivity significantly above the blank values. In the gastro-intestinal tract and liver, radioactivity levels were very well correlated
with the blood values at all times after oral administration. The rate of disappearance from tissues and blood suggests that no accumulation of the dye and/or its metabolites occurs.
Recovery in the urine and faeces accounted for 50% of the oral dose of ~4C activity in the first 16 hr after dosing and for as much as 90% over a 32-hr period.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- No data available
Any other information on results incl. tables
Gastrointestinal tract, liver, kidneys, lungs, spleen, brain, testes, muscles, adipose tissues are the organs exhibiting radioactivity
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
The chemical Carmoisine is expected to have “low bio-accumulation potential” within the body of rats. - Executive summary:
The absorption, distribution and excretion of the red azo dye carmoisine (Ext. D & C No. 10) was studied in male rats. [14C]Carmoisine was administered in a dose of 200 mg/kg (25/~Ci) by gavage. Radioactivity was measured in blood, tissue, faeces and urine at different times after dosing.
After oral administration of the dye, no radioactivity was detected in the brain, adipose tissue, muscle, testes, spleen or lung, and recovery of the administered activity in faeces and urine was almost complete by 32 hr. The radioactivity profile of the blood indicated rapid but poor absorption of [14C]carmoisine, a maximum radioactivity content corresponding to 0.01% of the dose per ml of blood being reached within 10 min.
The highest levels of radioactivity occurred in the gastro-intestinal tract and liver after the injection but after 24hr no radioactivity was detectable in these or other tissues.
The bioavailability of [14C]carmoisine, calculated from the blood-radioactivity curves after oral was less than 10%.
Thus, from the above, it can be concluded that the chemical Carmoisine is expected to have “low bio-accumulation potential” within the body of rats.
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