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EC number: 219-091-5 | CAS number: 2353-45-9
- 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
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: Experimental data from authoritative journal
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 955
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The objective of the study was to determine precisely the fate after ingestion of all the FD&C triphenylmethane colors, FD&C Blue No. 1, FD&C Green No. 1, FD&C Green No.2, FD&C Green No.3, and FD&C Violet No. 1 colors.
- GLP compliance:
- no
Test material
- Reference substance name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- EC Number:
- 219-091-5
- EC Name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- Cas Number:
- 2353-45-9
- Molecular formula:
- C37H36N2O10S3.2Na
- IUPAC Name:
- disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)-5-hydroxybenzenesulfonate
- Reference substance name:
- dihydrogen(ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino] (4-hydroxy-2-sulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene] (3-sulphonatobenzyl)ammonium,disodium salt [Synonym FD&C Green No.3 & Fast Green FCF]
- IUPAC Name:
- dihydrogen(ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino] (4-hydroxy-2-sulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene] (3-sulphonatobenzyl)ammonium,disodium salt [Synonym FD&C Green No.3 & Fast Green FCF]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- CAS No: 2353-45-9Chemical Name: Benzenemethanaminium,N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-,inner salt, sodium salt [Synonym FD&C Green No.3 & Fast Green FCF]Nature of chemical: Organic
Constituent 1
Constituent 2
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Three male and three female adult Osborne-Mendel rats, weighing between 450-500 gm. and 200-250 gm. respectively, were starved for 24 hours, and then each given 200 mg of color dissolved in 10 ml. of water per os.The rats were then placed in metabolism where food and water were available, and the urine and feces were collected for 36 hours when the feces no longer showed any trace of the administered color.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on exposure:
- Three male and three female adult Osborne-Mendel rats, weighing between 450-500 gm. and 200-250 gm. respectively, were starved for 24 hours, and then each given 200 mg of color dissolved in 10 ml. of water per os.The rats were then placed in metabolism where food and water were available, and the urine and feces were collected for 36 hours when the feces no longer showed any trace of the administered color.
- Duration and frequency of treatment / exposure:
- Exposure period: 36 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:200 mg
- No. of animals per sex per dose / concentration:
- 3 male & 3 female rats
- Control animals:
- not specified
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Upon administraton by mouth (oral), the color was absorbed in the gastro-intestinal tract. There was some evidence that more color was absorbed in the upper portion of the intestinal tract than in the lower portion.
- Type:
- distribution
- Results:
- The administered color was distibuted through the gut, and kidneys
- Type:
- metabolism
- Results:
- The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates very poor metabolism of the administered color.
- Type:
- excretion
- Results:
- The average percentage of the FD&C Green No.3 colour recovered in rats was 94% (standard error of average 1.32) in 36 hours. None of the colors was found in the urine
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
It was found that the administered colors with one exception were almost completely excreted in the feces of the test animals (male & female). The average percentage of theFD&C Green No.3 colour recovered in rats was 94% (standard error of average 1.32) in 36 hours. None of the colors was found in the urine, and since they were nearly all excreted in the feces, bio-accumulation potential of the color after a single administration appears to be low in rats
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study resultsIn an in-vivo study conducted on 3 male and female adult Osborne-Mendel rats, who were administered 200 mg of the color FD&C Green No.3 as a single dose, almost complete recovery (94%) of the administered color was found in the excreta of the rats in 36 hours. None of the colors was found in the urine. The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates poor metabolism of the administered color. Thus, it can be concluded that the color FD&C Green No.3 when administered as a single dose by the oral route to the rats is likely to exhibit low bio-accumulation potential.
- Executive summary:
In an in-vivo study conducted on 3 male and female adult Osborne-Mendel rats, who were administered 200 mg of the color FD&C Green No.3 as a single dose, almost complete recovery (94%) of the administered color was found in the excreta of the rats in 36 hours.None of the colors was found in the urine.The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates poor metabolism of the administered color.
Thus, it can be concluded that thecolorFD&C Green No.3 when administered as a single dose by the oral route to the rats is likely to exhibit low bio-accumulation potential.
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