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Diss Factsheets
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EC number: 204-254-5 | CAS number: 118-47-8
- 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:
- other: data from peer reveiwed journal
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 and G. N. McEwEN, JR
- Year:
- 1 992
- Bibliographic source:
- Fd Chem. Toxic. Vol. 30, No. 12, pp. 1051-1055, 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Eye irritation of chemical tartrazine was conducted on rabbits.
- GLP compliance:
- 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
- IUPAC Name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Reference substance name:
- Tartrazine
- IUPAC Name:
- Tartrazine
- Details on test material:
- - Name of test material (as cited in study report): Tartrazine
- Molecular formula (if other than submission substance): C16-H12-N4-O9-S2.3Na
- Molecular weight (if other than submission substance): 534.3681
- Substance type: Organic
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Summit View Farm, Hazelton, PA, USA
- Age at study initiation:
- 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%
- Photoperiod (hrs dark / hrs light): 12-hr
light/dark cycle
Test system
- Vehicle:
- other: aqueous solution with 0.5 % (w/v) hydroxypropyl methylcellulose and 0.25 % (w/v) laureth-10 acetate)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 30 μl of test solution (3 % (w/v)
- Duration of treatment / exposure:
- 1 application daily for 21 days
- Observation period (in vivo):
- Ophthalmic observations were conducted on days 3, 7 and 14 always prior to instillation.
- Number of animals or in vitro replicates:
- 6 female and 6 male New Zealand White rabbits
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure:Right eye of rabbit
- % coverage:
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:Draize procedure
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24
- Remarks on result:
- other: 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.
- Irritant / corrosive response data:
- 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. - Other effects:
- No lethality or significant clinical signs, and no substance-related weight change were observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating effects were known in skin irritation of chemical tartrazine exposed to rabbit’s eye daily for 21 days.
- Executive summary:
Eye irritation test was conducted on 6 female and 6 male New Zealand White rabbits.30 μl of test chemical in aq. solution was administered into the right eye of rabbits and left eyes served as untreated controls.
Ocular irritation was determined according to a modification of the Draize test. All animals were checked for viability twice daily.Ocular irritation was scored 24 h after each treatment and prior to the next instillation. On days 1, 3, 7, 14, and 21 the eyes were also evaluated 1 h after treatment. 24 h after each treatment
additionally eye stain and particle depositions were scored. Ophthalmic observations were conducted on days 3, 7 and 14 always prior to instillation.
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,tartrazine it is not expected to cause irritant effects following repeated treatment of eyes in a concentration of 3 % in aqueous solution.
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