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reaction mass of: tetrasodium 7-(4-(4-fluoro-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate;tetrasodium 7-(4-(4-hydroxy-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
EC number: 427-650-1 | 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:
- 20 January 1998 to 06 February 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to recent EU & OECD test guidance in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 427-650-1
- EC Name:
- -
- IUPAC Name:
- reaction mass of: tetrasodium 7-(4-(4-fluoro-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate and tetrasodium 7-(4-(4-hydroxy-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktivgleb FD 08064
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
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- 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 under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (±3°C)
- Humidity (%): 50 (±20%)
- Photoperiod (hrs dark / hrs light): 12 hours daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg applied neat. - Duration of treatment / exposure:
- Exposure 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): isotonic saline at approx. 37 °C
- Time after start of exposure: 24 hours
SCORING SYSTEM: Scale for scoring ocular reactions
TOOL USED TO ASSESS SCORE: fluorescein-sodium solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Animal 63
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Animal 64
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Animal 82
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Animal 63
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Animal 64
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Animal 82
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Animal 63
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- Animal 82
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Animal 64
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Animal 63
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- Animal 64
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- Animal 82
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- One and 24 hours after administration the conjunctivae of the animals showed definetely injected blood vessels up to a difuse crimson red color and sporadically very slight up to obvious swellings. Additionally, clear from the substance colored eye discharge was noted. 48 hours after administration the conjunctivae of one animal showed definetely injected blood vessels. 72 hours after administration all signs of irritation were reversible.
Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:
Opacity of cornea all animals : 0.00
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.00
Ins all animals : 0.00
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.00
Redness of
conjunctiva all animals : 0.55
animal 63 : 0.33
animal 64 : 0.33
animal 82 : 1.00
Chemosis of
conjunctiva all animals : 0.11
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.33
Testing of the substance for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- One and 24 hours after administration the conjunctivae of the animals showed definetely injected blood vessels up to a difuse crimson red color and sporadically very slight up to obvious swellings. Additionally, clear from the substance colored eye discharge was noted. 48 hours after administration the conjunctivae of one animal showed definetely injected blood vessels. 72 hours after administration all signs of irritation were reversible.
Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:
Opacity of cornea all animals : 0.00
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.00
Ins all animals : 0.00
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.00
Redness of
conjunctiva all animals : 0.55
animal 63 : 0.33
animal 64 : 0.33
animal 82 : 1.00
Chemosis of
conjunctiva all animals : 0.11
animal 63 : 0.00
animal 64 : 0.00
animal 82 : 0.33
Testing of the substance for primary eye irritation in the rabbit showed, that the substance is not irritating to eye. - Executive summary:
Study conducted to EU test guidance 92/69/EEC part B5 and to OECD test guideline 405 in compliance with GLP.
One and 24 hours after administration the conjunctivae of the animals showed definitely injected blood vessels up to a difusse crimson red colour and sporadically very slight up to obvious swellings. Additionally, clear from the substance coloured eye discharge was noted. 48 hours after administration the conjunctivae of one animal showed definitely injected blood vessels. 72 hours after administration all signs of irritation were reversible.
Testing of the substance for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
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