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EC number: 464-700-1 | CAS number: 607724-42-5
- 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:
- From Apr. 19, 2005 to May 10, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 464-700-1
- EC Name:
- -
- Cas Number:
- 607724-42-5
- Molecular formula:
- Hill formula: C28H24N5Na5O23S7 CAS formula: C28H29N5O23S7.5Na
- IUPAC Name:
- pentasodium 4-hydroxy-3-(2-{2-methoxy-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-7-[(sulfonatomethyl)amino]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Red F01-0481
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: 3.63 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 50 ± 20 %
- Air changes:
IN-LIFE DATES: From: Apr. 19, 2005 To: May 10, 2005
Test system
- Vehicle:
- not specified
- Remarks:
- No vehicle used
- Controls:
- other: the untreated right eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 24 h after start of exposure with isotonic saline at approx. 37 °C
SCORING SYSTEM: as per OECD Guideline
TOOL USED TO ASSESS SCORE: fluorescein and UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Irritant / corrosive response data:
- From 1 h up to 72 h after administration the conjunctiva showed definitely injected blood vessels up to a crimson red color and up to 24 h after treatment some swelling above normal up to obvious swelling with partial eversion of lids. 24 h after application the nictitating membrane of the animal was discolored by the test item up to the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the substance caused discoloration of the nictitating membrane of rabbit eye until end of the study period. No other signs of irritation were observed.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance in one NZW White rabbit according to OECD Guideline 405 and EU Method B.5, in compliance with GLP.
A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of the animal. The treated eye was washed out 24 h after administration. The untreated eye served as a control.
Overall mean scores for eye irritation were calculated to be 0.0 for iris and opacity of cornea, 1.33 for redness of conjunctiva and 0.33 for chemosis of conjunctiva. 24 h after the application, the nictitating membrane was discoloured by the test substance up to the end of the study. No clinical signs of systemic toxicity were seen. Body weight gain of the treated animal was not affected.
Due to the fact that a classification of R41 under DSD/DPD was warranted due to the non-reversible discolouration of the nictitating membrane, no further animals were tested due to animal welfare reasons. However, as only the conjunctivae of the rabbit eye were discoloured. And no other signs of eye irritation were found, following the criteria of Regulation (EU) 1272/2008, no classification applies in terms of serious eye irritation/eye damage.
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