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EC number: 287-257-4 | CAS number: 85443-67-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
Test material
- Reference substance name:
- Hydrogen [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- EC Number:
- 287-257-4
- EC Name:
- Hydrogen [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Cas Number:
- 85443-67-0
- Molecular formula:
- C16 H11 Cr N5 O8 S .C11 H25 N O .H
- IUPAC Name:
- 1-Propanamine, 3-[(2-ethylhexyl)oxy]-,(T-4)-[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]hydroxychromate(1-)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: About 3-4 months
- Weight at study initiation: 2.56 - 2.69 kg
- Housing: Singly housing in stainless steel wire mesh cages with grating, floor area: 3000 cm².
- Diet: standardized animal laboratory diet (about 130 g/animal/day)
- Water: ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%.
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL bulk volume (about 25 mg of the comminuted test substance)
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Body weight determination just before application of the test substance and after the last reading.
The test substance was applied in a single dose to the conjunctival sac of the right eyelid.
About 1 hour after application of the solid test substance the treated eye of the animals was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
Readings approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.
Check for dead or moribund animals: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
The evaluation of eye irritation is performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Slight to moderate conjunctival redness, slight conjunctival chemosis and slight to moderate discharge were observed during the course of the study. In addition injected scleral vessels in a circumscribed area were noted during the study period.
Any other information on results incl. tables
INDIVIDUAL OCULAR EXAMINATIONS AND MEAN VALUES
Readings |
Animal | Cornea | Iris | Conjunctiva | Additional findings | |||
Opacity | Area of cornea involved | Redness | Chemosis | Discharge | ||||
1 h | 01 | 0 | 0 | 0 | 1 | 1 | 1 | * |
02 | 0 | 0 | 0 | 2 | 1 | 1 | * | |
03 | 0 | 0 | 0 | 2 | 1 | 2 | * | |
24 h | 01 | 0 | 0 | 0 | 1 | 0 | 0 | * |
02 | 0 | 0 | 0 | 1 | 0 | 0 | * | |
03 | 0 | 0 | 0 | 1 | 0 | 0 | * | |
48 h | 01 | 0 | 0 | 0 | 0 | 0 | 0 | * |
02 | 0 | 0 | 0 | 0 | 0 | 0 | ||
03 | 0 | 0 | 0 | 0 | 0 | 0 | ||
72 h | 01 | 0 | 0 | 0 | 0 | 0 | 0 | |
02 | 0 | 0 | 0 | 0 | 0 | 0 | ||
03 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Mean 24- 72 h | 01 | 0.0 | 0.0 | 0.3 | 0.0 | |||
02 | 0.0 | 0.0 | 0.3 | 0.0 | ||||
03 | 0.0 | 0.0 | 0.3 | 0.0 | ||||
Mean | 0.0 | 0.0 | 0.3 | 0.0 | ||||
* Scleral vessels injected, circumscribed area
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 25 mg) of the test substance to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals) . About 1 hour after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Slight to moderate conjunctival redness, slight conjunctival chemosis and slight to moderate discharge were observed during the course of the study. In addition injected scleral vessels in a circumscribed area were noted during the study period. The ocular reactions were reversible in all animals within 72 hours after application at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and for chemosis and 0.3 for conjunctival redness. Considering the described ocular reactions as well as the average score for irritation, the test item does not show an eye irritation potential under the test conditions chosen.
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