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EC number: 260-394-7 | CAS number: 56819-40-0
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- 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:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 * 191.12), a transcript of which is attached as Appendix I to this report.
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- EC Number:
- 260-394-7
- EC Name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- Cas Number:
- 56819-40-0
- Molecular formula:
- C32H21CrN10O11S.2Na
- IUPAC Name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 20010/A
Purity: 57 %
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Not available
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- six animals
- Details on study design:
- SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading).
- No ulceration or opacity:...................................................................................................................................... 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible:................ 1
- Easily discernible translucent area, details of iris slightly obscured:......................................................................... 2
- Nacrous area, no details of iris visible, size of pupil barely discernible:..................................................................... 3
- Opaque cornea, iris not discernible through the opacity:......................................................................................... 4
IRIS
- Normal:............................................................................................................................................................... 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof,
iris still reacting to light (sluggish reaction is positive):.............................................................................................. 1
- No reaction to light, haemorrhage, gross destruction (any or all of these):.................................................................. 2
CONJUNCTIVAE
Redness: (refers to palpebral and bulbar conjunctivae, cornea and iris)
- Blood vessels normal:............................................................................... 0
- Some blood vessels definitely hyperaemic (injected):................................... 1
- Diffuse, crimson colour, individual vessels not easily discernible:................... 2
- Diffuse, beefy red:..................................................................................... 3
Chemosis: lids and/or nictitating membranes
- No swelling..................................................................................... 0
- Any swelling above normal (includes nictitating membranes)............... 1
- Obvious swelling with partial eversion of lids....................................... 2
- Swelling with lids about half closed.................................................... 3
- Swelling with lids more than, half closed............................................. 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.277
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Two animals gave "positive" reactions. Temporary corneal opacities developed in these two animals. A temporary dulling of the normal corneal lustre was observed in one other animal.
A diffuse crimson-red colouration of the conjunctivae was observed in one of these animals and considerable swelling of the conjunctivae with partial eversion of the eyelids in two animals. Mild conjunctival reactions were observed in the four remaining animals.
Any other information on results incl. tables
Numerical scores awarded to the ocular reactions eleicited by FAT 20010/A
Animal Number | Region of eye | Day | ||||||
1 | 2 | 3 | 4 | 7 | 14 | 21 | ||
1 | Cornea | 0 | 5 | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjuctivae | 10 | 6 | 0 | 0 | 0 | 0 | 0 | |
Total | 10 | 11 | 0 | 0 | 0 | 0 | 0 | |
2 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjuctivae | 6 | 0 | 0 | 0 | 0 | 0 | 0 | |
Total | 6 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjuctivae | 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
Total | 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
4 | Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjuctivae | 6 | 0 | 0 | 0 | 0 | 0 | 0 | |
Total | 6 | 0 | 0 | 0 | 0 | 0 | 0 | |
5 | Cornea | 15 | 5 | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjuctivae | 12 | 8 | 4 | 4 | 2 | 0 | 0 | |
Total | 27 | 13 | 4 | 4 | 2 | 0 | 0 | |
6 | Cornea | D | D | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjuctivae | 4 | 2 | 0 | 0 | 0 | 0 | 0 | |
Total | 4 | 2 | 0 | 0 | 0 | 0 | 0 | |
Total Score | 55 | 26 | 4 | 4 | 2 | 0 | 0 | |
Mean Rabbit | 9 | 4 | <1 | <1 | <1 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20010/A is considered to be non-irritant to the rabbit eye.
- Executive summary:
In a study performed as prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 * 191.12) exposing six rabbit eyes to FAT 20010 and observed for 7 days. The ocular reactions were scored by the method described by J. H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p 51. Two animals gave "positive" reactions. Temporary corneal opacities developed in these two animals. A temporary dulling of the normal corneal lustre was observed in one other animal. A diffuse crimson-red colouration of the conjunctivae was observed in one of these animals and considerable swelling of the conjunctivae with partial eversion of the eyelids in two animals. Mild conjunctival reactions were observed in the four remaining animals. Based on the results, FAT 20010/A is considered to be non-irritant to the rabbit eye.
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