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EC number: 299-257-1 | CAS number: 93858-25-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- 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 reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety of ingestion of yellow tartrazine by double-blind placebo controlled challenge in 26 atopic adults
- Author:
- S. Pestana, M. Moreira, B. Oleja
- Year:
- 2 010
- Bibliographic source:
- Allergol Immunopathol (Madr). 2010;38(3):142–146
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as method below
- Principles of method if other than guideline:
- Double-blind, placebo-controlled food challenge (DBPCFC) was performed to assess the sensitization potential of Tartrazine in humans
- GLP compliance:
- not specified
- Type of study:
- other: Double-blind, placebo-controlled food challenge (DBPCFC)
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
- Test material form:
- solid
- Details on test material:
- - Name of test material (IUPAC name): trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Common name: Acid Yellow 23,Tartrazine
- Molecular formula: C16H9N4Na3O9S2
- 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
- Physical state:Soild
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
- Common name: Acid Yellow 23,Tartrazine
- Molecular formula: C16H9N4Na3O9S2
- 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
- Physical state:Soild
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Antonio Pedro University Hospital
- Age at study initiation: 18–65 years old
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): Dye–free, nutritionally balanced meal
- Water (e.g. ad libitum): No data available
- 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
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: oral
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 5, 10, 20 and 35 mg
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: oral
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 5, 10, 20 and 35 mg
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 26
- Details on study design:
- RANGE FINDING TESTS: No data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data available
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: No data available
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: 1 week
- Exposure period: 60 min
- Test groups: 1
- Control group: No data available
- Site: No data available
- Concentrations: 5, 10, 20 and 35 mg
- Evaluation (hr after challenge): Erythematous rash, Pruritus, Urticaria/angioedema was examined.
OTHER: Double-blind placebo controlled cross-over challenge (DBPCC) was used, gold standard method in the diagnosis of allergic reactions to food and drugs. Capsules were manufactured by an external pharmacist who maintained the code until all the challenges were completed. Briefly, each volunteer was challenged either with tartrazine (Yellow dye no. 5, FD & C) in one visit, or placebo (talc) on another visit, one week apart. In the first visit, patients were randomised to receive three identical opaque capsules containing tartrazine or placebo (talc) in three steps. The administered dose of tartrazine was progressively increased from 5mg in the first administration to 10mg in the second one and to 20 mg in the last one.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 2
- Group:
- test chemical
- Dose level:
- 35 mg
- No. with + reactions:
- 0
- Total no. in group:
- 26
- Clinical observations:
- No Erythematous rash, Pruritus, Urticaria/angioedema observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Symptoms score sheeta
|
0 (absent) |
1 (mild) |
2 (moderate) |
3 (severe) |
Skin |
|
|
|
|
Erythematous rash |
|
Few areas of faint Erythema |
Areas of erythema, macular and raised rash |
Generalised marked erythema (450%); extensive raised lesion (25%); vesiculation and/or piloerection |
Pruritus |
|
Occasional scratching |
Scratching continuously for 42 min at a time |
Hard continuous scratching, excoriations |
Urticaria/angioedema |
|
< 3 hives |
< 10 hives to > 3 |
Generalised Involvement |
Double-blind placebo controlled challenge with yellow tartrazine in atopic adults
|
Bock’s score |
|
Cutaneous |
Placebo |
|
Baseline |
0.11 ± 0.58a |
Last evaluation |
0.19 ± 0.56 |
Tartrazine |
|
Baseline |
b |
Last evaluation |
0.30 ± 0.61n |
Placebo vs. tartrazine |
0.15 |
aMean7SD.
bScore zero.
np < 0.05 vs. baseline.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No Erythematous rash, Pruritus, Urticaria/angioedema observed in any of the 26 human volunteers.Tartrazine was considered to be not sensitizing when atopic adults were tested by using Double-blind placebo controlled challenge.
- Executive summary:
Double-blind, placebo-controlled food challenge (DBPCFC) was performed to assess the sensitization potential of Tartrazine in humans
Double-blind placebo controlled cross-over challenge (DBPCC) was used, gold standard method in the diagnosis of allergic reactions to food and drugs. Capsules were manufactured by an external pharmacist who maintained the code until all the challenges were completed. Briefly, each volunteer was challenged either with tartrazine (Yellow dye no. 5, FD & C) in one visit, or placebo (talc) on another visit, one week apart. In the first visit, patients were randomised to receive three identical opaque capsules containing tartrazine or placebo (talc) in three steps. The administered dose of tartrazine was progressively increased from 5mg in the first administration to 10mg in the second one and to 20 mg in the last one.
Patients were examined for Erythematous rash, Pruritus and Urticaria/angioedema fifty minutes after the ingestion of each capsule, and 2 h after the last one. All patients stayed under observation for three hours after taking the last dose. All the subjects answered a questionnaire about symptoms after this period and were interviewed by phone the next day.
No Erythematous rash, Pruritus, Urticaria/angioedema observed in any of the 26 human volunteers. Tartrazine was considered to be not sensitizing when atopic adults were tested by using Double-blind placebo controlled challenge.
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