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EC number: 290-920-0 | CAS number: 90294-36-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: 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:
- Evaluation of the cumulative (repeated application) eye irritation and corneal staining potential of FD&C yellow no. 5, FD&C blue no. 1 and FD&C blue no. 1 aluminium lake.
- Author:
- S D Gettings, D L Blaszcak, M T Roddy, A S Curry, G N McEwen.
- Year:
- 1 992
- Bibliographic source:
- Food & Chemical Toxicology, Vol. 30, No. 12, pp. 1051-1055, 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize test
- Principles of method if other than guideline:
- To determine the ocular irritation potential of Tartrazine (FD & C Yellow No. 5) produced by repeated topical application to rabbit eyes
- 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
- 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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Summit View Farm, Hazelton, PA, USA
- Age at study initiation:N/A
- Weight at study initiation:3.0-3.5 kg
- Housing:Rabbits were individually housed in stainless steel, wire mesh-floor cages in a room.
- Diet (e.g. ad libitum):Feed (Certified Lab Rabbit Chow HF; Purina No. 5325) was limited to 125g/day.
- Water (e.g. ad libitum):ad libitum
- Acclimation period:All animals were acclimatized for at least 2 wk prior to the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):16-21°C
- Humidity (%):38%
- Air changes (per hr):N/A
- Photoperiod (hrs dark / hrs light):12-hr light/dark cycle
Test system
- Vehicle:
- other: aqueous vehicle containing 0.5% (w/v) hydroxypropyl methylcellulose and 0.25% (w/v) laureth-10 acetate
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution):30 μl of test solution
VEHICLE
- Amount(s) applied (volume or weight with unit):3%
- Concentration (if solution):3 % (w/v) Acid Yellow 23 in aqueous solution with 0.5 % (w/v) hydroxypropyl methylcellulose and 0.25 % (w/v) laureth-10 acetate
- Lot/batch no. (if required):N/A
- Purity:N/A - Duration of treatment / exposure:
- 21 days
- Observation period (in vivo):
- All eyes were scored for ocular irritation pretest (8 days, 24 hr and immediately prior to the initial dose) and approximately 24 hr after each treatment, prior to the next instillation of test material; on days 1, 3, 7, 14 and 21, the eyes were also evaluated for irritation 1 hr after treatment
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6 of each sex per group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure:Ophthalmic observations were performed 7 days and 24 hr prior to the initial dose,on days 3, 7 and 14 (prior to daily dosing), and at the end of the study.
SCORING SYSTEM:Draize test
All eyes were scored for ocular irritation pretest (8 days, 24 hr and immediately prior to the initial dose) and approximately 24 hr after each treatment, prior to the next instillation of test material; on days 1, 3, 7, 14 and 21, the eyes were also evaluated for irritation 1 hr after treatment
TOOL USED TO ASSESS SCORE: Determined by gross ocular examination,slit-lamp biomicroscope (including examinations of fluorescein stain retention to evaluate integrity of the corneal epithelium) and indirect ophthalmoscope examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 7 out of 12
- Time point:
- other: 3,4,7 and 8 days after 1 hr and 24 hr treatmennt
- Score:
- 4
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Slight conjunctival redness seen in the eyes of both test and control animals throughout the study.
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal: 6 out of 12
- Time point:
- other: 1,3 and 4 days after 1 hr and 24 hr treatment
- Score:
- 1
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- other: Slight conjunctival discharge seen in the eyes of both test and control animals throughout the study.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 3, 7, 14, and 21 days
- Score:
- 0
- Max. score:
- 12
- Reversibility:
- not specified
- Remarks on result:
- other: All animals were free of significant signs of ocular irritation.All animals were free of significant signs of eye staining and partial embedment.
- Irritant / corrosive response data:
- No lethality or significant clinical signs, and no substance-related weight change were observed. Except slight conjunctival redness or discharge, that were seen sporadically in the eyes of the animals, all animals were free of significant signs of ocular irritation. No significant signs of eye staining or particle depositions were observed. At ophthalmoscopic examinations, no ocular abnormities were noticed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- No lethality or significant clinical signs, and no substance-related weight change were observed. Except slight conjunctival redness or discharge, that were seen sporadically in the eyes of the animals, all animals were free of significant signs of ocular irritation. No significant signs of eye staining or particle depositions were observed. At ophthalmoscopic examinations, no ocular abnormities were noticed.
Hence, FD&C Yellow No.5 (tartrazine) was not expected to cause any irritant effects following repeated exposure to rabbit eyes. - Executive summary:
A study was performed to evaluate the staining, embedment and ocular irritation potential of Tartrazine (FD & C Yellow No. 5) in rabbits. The study was performed according to a modification of the Draize test (Draize, 1959).
Tartrazine (FD & C Yellow No. 5) was prepared daily as a 3% (w/v) suspension in aqueous vehicle containing 0.5% (w/v) hydroxypropyl methylcellulose and 0.25% (w/v) laureth -10 acetate.Tartrazine (FD & C Yellow No. 5) 3% w/v in aqueous vehicle was administered once daily, for a total of 21 days, to the conjunctival sac of the right eye of New Zealand White Rabbits (6 of each sex/ group) at a dose volume of 30µl. Control animals (6 of each sex) received 30/µl of the vehicle daily. Ocular irritation was determined according to a modification of the Draize test (Draize, 1959). Interpretation of observations and assignment of scores were consistent with those described by the Consumer Product Safety Commission (1972).All eyes were scored for ocular irritation pretest (8 days, 24 hr and immediately prior to the initial dose) and approximately 24 hr after each treatment, prior to the next instillation of test material; on days 1, 3, 7, 14 and 21, the eyes were also evaluated for irritation 1 hr after treatment. In addition, all readily observable ocular structures were evaluated for eye stain and particle embedment 24 hr after each treatment.
No lethality or significant clinical signs, and no substance-related weight change were observed. Except slight conjunctival redness or discharge, that were seen sporadically in the eyes of the animals, all animals were free of significant signs of ocular irritation. No significant signs of eye staining or particle depositions were observed. At ophthalmoscopic examinations, no ocular abnormities were noticed.
Hence, FD&C Yellow No.5 (tartrazine) was not expected to cause any irritant effects following repeated exposure to rabbit eyes.
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