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EC number: 235-428-9 | CAS number: 12225-21-7 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 19140:1.
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- The Metabolism and Excretion of Tartrazine in Rat, Rabbit and Man
- Author:
- R. Jones, A. J. Ryan and S. E. Wright
- Year:
- 1 964
- Bibliographic source:
- Food & Cosmetic Toxicology. Vol. 2, pp. 447-452, 1964
Materials and methods
- Objective of study:
- other: To study the metabolism and excretion of Tartrazine in Rat, Rabbit & Man
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Tartrazine was given to rats by intraperitoneal injection or by stomach tube in aqueous solution. Intraperitoneal doses were at the rate of 2.4 mg/kg and the amount of tartrazine excreted in urine was determined.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- EC Number:
- 217-699-5
- EC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Cas Number:
- 1934-21-0
- Molecular formula:
- C16-H12-N4-O9-S2.3Na
- IUPAC Name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Details on test material:
- - Name of test material (IUPAC name): Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Name of test material :Tartrazine
- Molecular formula:C16H12N4O9S2.3Na
- Molecular weight :534.3681 g/mol
- Smiles notation: n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
-InChl:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;;
- Substance type:Organic
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- [14C]tartrazine
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Tartrazine was given to rats by intraperitoneal injection or by stomach tube in aqueous solution. Intraperitoneal doses were at the rate of 2.4 mg/kg; oral doses were 5 mg/rat.
Administration / exposure
- Route of administration:
- other: intraperitoneal injection or by stomach tube in aqueous solution
- Vehicle:
- water
- Details on exposure:
- [14C]Tartrazine was administered to rats by intraperitoneal injection at 2.4 mg/kg. Urine was collected for 48 hr and assayed for radioactivity. The acid-hydrolysed urine was examined for labelled sulphanilic acid by the addition of a known amount of unlabelled material, equilibration and isolation, followed by purification to constant specific activity.
- Duration and frequency of treatment / exposure:
- Urine was collected for 48 hr and assayed for radioactivity
Doses / concentrations
- Remarks:
- Doses / Concentrations:
intraperitoneal injection was given at 2.4 mg/kg & oral dosage was given at 5 mg/rat.
- No. of animals per sex per dose / concentration:
- Not specified
- Control animals:
- not specified
- Details on study design:
- Measurement of radioactivity: This was estimated using a gas flow Geiger-Muller counter. Pure compounds were counted at infinite thickness. Urine samples were counted as agar discs according to the method of McCready (1958).
Estimation of sulphanilic acid in urine: Sulphanilic acid was estimated before and after acid hydrolysis of the urine using the method described by Bratton & Marshall (1939) for sulphanilamide.
Paper chromatography of urinary metabolites: This was carried out in three solvent systems: butan-1-ol-2N-acetic acid-water (4:1:5, by vol.); butan-1-ol-2N-NH3 (1:1, by vol.); butan-1-ol-ethanol-water (7:1:2, by vol.). Amines were detected with Erhlich's reagent. - Details on dosing and sampling:
- [~4C]Tartrazine was administered to rats by intraperitoneal injection at 2.4 mg/kg & oral dosage was given at 5 mg/rat. Urine was collected for 48 hr and assayed for radioactivity.
Results and discussion
Main ADME results
- Type:
- excretion
- Results:
- After intraperitoneal injection, radioactivity was quantitatively recovered in the rat urine (Table 1) but no labelled sulphanilic acid could be found.
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Paper chromatography of the urine from rats dosed intraperitoneally with tartrazine showed only unchanged colouring present. No evidence was found for the presence of conjugated colouring. No amines derived from the reduction of the colouring in vivo could be found either before or after acid hydrolysis of the urine. In contrast to these results the urine of rats given oral doses of tartrazine contained no colouring, but sulphanilic acid was detected
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- sulphanilic acid was the metabolite identified by the oral route
Any other information on results incl. tables
Table 1.Excretion of radioactivity by rats after intraperitoneal dosage with[14C]tartrazine
Experiment no. |
Intraperitoneal dosage |
Percentage of administered radioactivity excreted during |
||
Weight (mg) |
Activity (cpm × 10-8) |
0-24 hr |
24-48 hr |
|
1 |
0.78 |
5.73 |
100.8 |
0 |
2 |
0.72 |
5.28 |
73.8 |
0 |
3 |
0.65 |
4.77 |
92.8 |
0 |
4 |
0.57 |
4.19 |
91.5 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
Since majority (almost 92%) of the administered tartrazine is metabolized and excreted out of the Rat, it cn be concluded that the chemical shall have low bio-accumulation potential. - Executive summary:
The results obtained in these experiments show that tartrazine can be reduced in vivo when given orally but not when given by intraperitoneal injection. It must be concluded, therefore, that reduction of this compound is carried out by the gastro-intestinal flora.
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