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EC number: 229-054-5 | CAS number: 6408-31-7
- 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:
- weight of evidence
- 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 peer review publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute Toxicity of Food additives Tartrazine and carmoisine on white male Mice
- Author:
- Lamia A. M. Ai-Mashhedy, Ali N. Fijer
- Year:
- 2 016
- Bibliographic source:
- International Journal of Pharm Tech Research,Vol.9, No.4, pp 364-367, 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of Tartrazine was conducted on white male mice.
- GLP compliance:
- no
- Test type:
- other: No data available
- Limit test:
- no
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:
- C16H12N4O9S2.3Na
- 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
- Specific details on test material used for the study:
- - 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
Test animals
- Species:
- mouse
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: college of science at the University of Babylon
- Age at study initiation:8-9 weeks old
- Weight at study initiation: 25-30 gm
- Housing: animals were housed in polyacrylic cages, not more than three animals per cage under standard laboratory condition
- Diet (e.g. ad libitum): standard diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2C°
- Humidity (%):50-55%
- Photoperiod (hrs dark / hrs light): 12 hrs. Light: dark cycle
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data available
- Doses:
- 1250 mg/kg ,2500 mg/kg ,3750 mg/kg ,5000 mg/kg , 6250 mg/kg
- No. of animals per sex per dose:
- 1250 mg/kg- 6 animals
2500 mg/kg-6 animals
3750 mg/kg-6 animals
5000 mg/kg-6 animals
6250 mg/kg-6 animals - Control animals:
- yes
- Details on study design:
- Details on study design
- Duration of observation period following administration:3 days
- Frequency of observations and weighing:No data available
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The mice were observed for 3 days for the signs and symptoms of toxicity as well as the death rate of each group were recorded. - Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 6 250 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No mortality was recorded at highest dose 6250 mg/kg BW.
- Clinical signs:
- other: No toxic effects were recorded in all the doses administered.
- Gross pathology:
- No data available
- Other findings:
- The LD50 of the substances was calculated using the arithmetic method of Karber
The LD50 was calculated using the following formula:
LD50 =LDy – Σ (Dd x md)/N
Where LDy =Highest dose (LD100)
N =Number of animals per group
Dd =Dose difference
Md =Mean dead
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The LD50 was considered to be >6250 mg/kg bw when male Sprague- Dawly white mice was treated with Tartrazine for 3 days via oral route.
- Executive summary:
Acute oral toxicity test was conducted in male Sprague- Dawly white mice using tartrazine at the dose concentration of 1250 mg/kg, 2500 mg/kg, 3750 mg/kg 5000 mg/kg, 6250 mg/kg to 6 animals per dose by oral route. Control animals received distilled water only. The mice were observed for 3 days for the signs and symptoms of toxicity as well as the death rate of each group were recorded. Tartrazine dye administration at single dose has not been found to be any toxic effects even at higher dose used (6250 mg/Kg BW) at the same time there is no mortality or morbidity was recorded in all grouped animals treated with tartrazine dye. Hence, LD50 was considered to be >6250 mg/kg bw when male Sprague- Dawly white mice was treated with Tartrazine for 3 days via oral route.
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