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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
Endpoint summary
Administrative data
Description of key information
Skin Sensitization:
No reactions were observed in the 53 patients tested with Tartrazine Aluminium lake in a patch test performed according to ICDRG Guidelines. Hence, Tartrazine Aluminum lake was considered to be not sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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 - 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
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000
- Concentration / amount:
- 5 % in vehicle
- Adequacy of induction:
- not specified
- 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
- 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin Sensitization:
The skin sensitization potential ofAluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complexwas evaluated in various studies. These studies include experimental data for the target as well its parent compound Tartrazine [CAS: 1934-21-0].
Patch tests were performed (Contact Dermatitis, 3 249-256 (1977)) 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.
A modified Buehler and Klecak method for open epicutaneous testing[OET] was performed by JOE DINARDO et.al [JOURNAL OF COSMETIC SCIENCE, 58, 209-214 May/June 2007] to assess the sensitization potential of Tartrazine [CAS: 1934-21-0].
Tartrazine was tested at an induction concentration of 10% and challenge concentrations of 10.0%, 5.0%, and 2 .5%.
For the induction phase, the left flanks of ten albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday, Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentrations(10.0%, 5.0%, and 2 .5%). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.
All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale. A positive control of 0.5% 2,4-dinitrochlorobenzene(DNCB) in ethanol was included for both the induction and challenge phases. Since a positive response was observed in the challenge exposure at 10% challenge exposure, Tartrazine was retested using a 1% induction exposure and challenge concentrations of 1.0%, 0.5%, and 0.25%.
Tartazine produced a positive reaction at 10% challenge exposure, but in the retest no reactions were observed at 1%, 0.5 and 0.25% challenge concentrations.
Hence, it was considered that Tartrazine does not induce any sensitization in guinea pigs when tested below 10% concentration.
The above results are supported by the Double-blind, placebo-controlled food challenge (DBPCFC) performed by S. Pestana et.al [Allergol Immunopathol (Madr), 2010;38(3):142–146]to assess the sensitization potential of Tartrazine[CAS: 1934-21-0] 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.
These results are further supported by the Maximisation test conducted [Evaluation and opinion on Acid Yellow 23, SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS -SCCNFP, adopted on 23 April 2004] according to OECD guideline 406 to ascertain the dermal sensitization potential of Tartrazine[CAS: 1934-21-0]. 5 % Acid Yellow 23 solution was applied to the skin of 10 albino guinea pigs in an emulsion of Freund´s Complete Adjuvant (FCA) for the intradermal induction. 1 week later, following treatment with sodium lauryl sulfate (SLS) the epidermal induction was conducted for 48 h under occlusion with a 50 % Acid Yellow 23 solution. 2 weeks later, the animals were challenged by epidermal application of Acid Yellow 23 (25 % solution) under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 h after removal of the dressing. For challenge reading, all animals were depilated 3 h before examination to remove the discolouration.
None of the control and test animals showed skin reactions after the challenge treatment with Acid Yellow 23. The 50 % test item stained the skin orange, therefore it was not possible to determine whether erythema were present or not. However, no oedema was observed.
Based on these observations, Tartrazine was considered to be not sensitizing to skin.
In an another Human patch test performed[Contact Dermatitis, 27, 22-26, (1992)] using uniform patch tests and following procedure described in European standard series. 32 patients (20 women, 12 men) all with a positive patch test reaction p-aminoazobenzene (0.25 petrolatum%).
Eleven patients had previously also shown sensitization to para-phenylenediamine (PPD). 10 (4 women, 6 men) out of the 32 cases were negative to all the test allergens of the European standard series. 30 patients with an allergic contact dermatitis but negative to p-aminobenzene and to PPD were also tested as control group with the same patch test series.
Tartrazine did not elicit an allergic reaction in any of the test volunteers. Hence, Tartrazine can be considered to be not sensitizing to human skin.
Available studies for the target and parent compound [CAS:1934-21-0] indicate a very strong possibility of Tartrazine Aluminium lake being not sensitizing to skin. Hence, Tartrazine Aluminium lake can be considered to be not a skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Available data for Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex suggests that it is not likely to cause any dermal sensitization to skin.
Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex can be considered to be not sensitizer to skin and can be classified under the category “Not Classified” as per CLP regulation.
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