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EC number: 258-027-0 | CAS number: 52587-68-5
- 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:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetic (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)
- EC Number:
- 258-027-0
- EC Name:
- Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)
- Cas Number:
- 52587-68-5
- Molecular formula:
- C38H25CrN8O7S.2Na
- IUPAC Name:
- Disodium [4-(hydroxy-kO)-3-{[5-(hydroxy-kO)-3-methyl-1-phenyl-1H-pyrazol-4-yl]diazenyl-kN1}benzenesulfonato(3-)][1-({2-(hydroxy-kO)-5-[phenyldiazenyl]phenyl}diazenyl-kN1)naphthalen-2-olato(2-)-kO]chromate(2-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Identification:21095/A
Purity: 80 %
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: Rabbits were kept separately in V2A wire-mesh cages
- Diet (e.g. ad libitum):Rabbits were fed on NAFAG, Gossau SG, rabbit food
- Water (e.g. ad libitum): ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Yes, right eye of rabbit served as control.
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Evaluation of the Eye Reactions
Cornea
A. Opacity-degree of density (area most dense taken for reading).
- No opacity: 0
- Scattered or diffuse area, details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
- Opaque, iris invisible: 4
B. Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter, but less than half: 2
- Greater than half, but less than three quarters: 3
- Greater than three quarters, up to whole area: 4
A x B x 5 Total maximum = 80
Iris
A. Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive): 1
- No reaction to light, hemorrhage, gross destruction (any or all of these): 2
Ax5
Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Vessels normal: 0
- Vessels definitely injected above normal: 1
- More diffuse, deeper crimson red, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
B. Chemosis
- No swelling: 0
- Any swelling above normal (includes nictitating membrane): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed: 3
- Swelling with lids about half closed to completely closed: 4
C. Discharge
- No discharge: 0
- Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
- Discharge with moistening of the lids and hairs just adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
(A + B + C) x 2 Total maximum =20
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.88
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eyes not rinsed
- Irritant / corrosive response data:
- The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae.
The irritation index was found to be 7.8 for the cornea, 0 for the iris and 5.8 for the conjunctivae.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21095/A is considered to be not irritating to rabbit eyes.
- Executive summary:
FAT 21095/A was tested for eye irritation potential on rabbits eye. This test was conducted in accordance with "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. Only rabbits showing normal ophthalmic findings were included in the test. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. In rinsed eyes, effects were observed on conjuctivae and cornea which were reversible within 7 days. Similar effects were observed in unrinsed eyes which were not reversible within 7 days. No effect on Iris was observed in both rinsed and unrinsed eye. Based on the findings of the study, FAT 21095/A is considered to be not irritating to rabbit eyes.
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