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EC number: 442-640-7 | CAS number: -
- 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:
- 2002-01-14 to 2002-03-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, only one animal tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 442-640-7
- EC Name:
- -
- Cas Number:
- 479541-17-8
- Molecular formula:
- Hill formula: C32H26CuFN9Na4O19S5
- IUPAC Name:
- Tetrasodium 2-(4-fluoro-6-(2-(2-sulfonatoethansulfonyl)ethyl amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(2-(2-hydroxy-5- sulfonatophenylazo)-4,5-dimethoxyphenylazo)-7-sulfonatonaphthalene-1-sulfonatocuprate(II)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Oliv F00-0149
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 3.4 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration of the test substance
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after administration the treated eye was washed out thoroughly with isotonic saline at approx. 37 °C. The eye was also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.
SCORING SYSTEM:
-Cornea: opacity (0-4), affected area (0-4)
-Iris (0-2)
-Conjunctivae: redness (0-3,9), chemosis (0-4), discharge (0-3)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0.67
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0.33
- Irritation parameter:
- chemosis score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 21 days
Any other information on results incl. tables
1 hour after the 72-hour injection a light redding of the conjunctiva was observed. 1 hour after the 24-hour injection
a light swelling occured. Clear green outflow. 2 days pa all signs of the swelling were disappeared.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information discolouration of the eye is considered a dye specific effect Criteria used for interpretation of results: expert judgment
- Conclusions:
- The applicant concluded that the persistent discolouration of the eye is a dye specific effect and does not require classification.
- Executive summary:
In a primary eye irritation study, 100 mg of Reactive Olive F00 -0149 was instilled into the conjunctival sac of the left eye of 1 New Zealand White rabbit for 24 hours. The treated eye was washed out thoroughly with isotonic saline at approx. 37 °C after 24 hours. Additionally, the eye was washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed. The animal was then observed for 3 days. Irritation was scored by the method described by Draize.
From one hour up to one day after application the conjunctiva of the animal showed injected blood vessels up to a diffuse crimson red color and swelling with partial eversion of the lid. Additionally, there was presence of a clear substance colored (green) eye discharge. 2 days after application the irritations had disappeared. Nictitating membrane and conjunctiva were green discolored from day 2 up to the end of the study. Redness and chemois of the conjunctiva received a score of 0.67 and 0.33, respectively, while the corneal opacity and iris scores were 0.
In this study, Reactive Olive F00-0149 would be an eye irritant based on persistent discoloration. However, the applicant concluded that the persistent discolouration of the eye is a dye specific effect and does not require classification.
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