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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Pigmented cosmetic dermatitis and coal tar dyes.
- Author:
- T Sugai, Y Takahashi, T Takagi.
- Year:
- 1 977
- Bibliographic source:
- Contact Dermatitis, 3 249-256 (1977).
- Reference Type:
- secondary source
- Title:
- OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23
- Author:
- SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS -SCCNFP
- Year:
- 2 004
- Bibliographic source:
- Evaluation and opinion on Acid Yellow 23, SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS -SCCNFP, adopted on 23 April 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the dermal sensitization potential of Tartrazine Aluminium lake in humans
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex
- EC Number:
- 235-428-9
- EC Name:
- Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex
- Cas Number:
- 12225-21-7
- Molecular formula:
- C48H33AlN12O27S6
- IUPAC Name:
- aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name of test material: Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex
- IUPAC name: aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate)
- Molecular formula: C48H33AlN12O27S6
- Molecular weight: 1429.19 g/mole
-Smiles:C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].[Al+3]
- Inchl: 1S/3C16H12N4O9S2.Al/c3*21-15-13(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;/h3*1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);/q;;;+3/p-3
- Substance type: Organic
- Physical appearance : Yellow to greenish-yellow powder.
- Purity as per Certificate of Analysis : 40.79%
- Lot No. : FG/16-17/0427
- Manufactured date : 19 May 2016
- Expiry Date : Shelf life of 8 years
- pH : 3.98 at 26.8°C
- Density : 0.283 g/cm3 at 26.8°C
- Storage conditions : Ambient (+15 to +25°C)
- SAFETY PRECAUTIONS: Gloves, cap and face mask were used in addition to protective body garments and shoes, to ensure adequate personal health and safety and to avoid inhalation and skin contact with the test item.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex
- Common Name: Tartrazine Aluminium lake
- IUPAC name: aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate)
- Molecular formula: C48H33AlN12O27S6
- Molecular weight: 1429.19 g/mole
- Smiles : C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].[Al+3]
- Inchl: 1S/3C16H12N4O9S2.Al/c3*21-15-13(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;/h3*1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);/q;;;+3/p-3
- Substance type: Organic
- Physical state: Solid Red powder
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Source: Patch test were performed in 53 patients with pigmented cosmetic dermatitis who had visited the authors clinic over the past 2 years
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000
- Concentration / amount:
- 5 % in vehicle
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000
- Concentration / amount:
- 5% in vehicle
- Day(s)/duration:
- 48 and 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 28 patients
- Details on study design:
- OTHER:
Patch tests were performed according to the standardized method recommended by the ICDRG
Patients had pigmented cosmetic dermatitis. The test substance was mixed at 5 % in a vehicle composed of 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000. The test were fixed with A1-test on Dermicel tape.
Scoring pattern for dermal reactions:
No reaction: -
Slight erythema: +
Erythema with slight papules: ±
Erythema with edema: ++
Erythema with vesicles and/or papules: +++ - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- no reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5% in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- no reactionns observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table: Results of the skin tests to representative coal tar dyes in patients with pigmented dermatitis
Name of the dye |
Legal name in USE |
PATCH TEST |
TOTAL NUMBER OF PATIENTS |
||
+
|
++
|
+++
|
|||
Tartrazine aluminium lake |
FDC- Y5 |
0 |
0 |
0 |
53 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Tartrazine Aluminium Lake in a patch test performed according to ICDRG Guidelines did not produce any dermal reactions in the human volunteers. Hence, Tartrazine Aluminum lake was considered to be not sensitizing to skin.
- Executive summary:
Patch tests were performed to assess the dermal sensitization potential of Tartrazine Aluminium lake in humans. Patch tests were performed according to the standardized method recommended by the ICDRG. The test was performed in 53 patients with pigmented cosmetic dermatitis who had visited the author’s clinic over the past 2 years. The test substance was mixed at 5 % in a vehicle composed of 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000. The test patches were fixed with A1 -test on Dermicel tape. The skin reactions were scored at 48 and 72 hours according to the following standards:
No reaction: -; Slight erythema: +; Erythema with slight papules: ±; Erythema with edema: ++; Erythema with vesicles and/or papules: +++
Tartrazine Aluminium Lake in a patch test performed according to ICDRG Guidelines did not produce any dermal reactions in the human volunteers. Hence, Tartrazine Aluminum lake was considered to be not sensitizing to skin.
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