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Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate
EC number: 941-533-7 | 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:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- EC Number:
- 401-560-2
- EC Name:
- Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- Cas Number:
- 108624-00-6
- Molecular formula:
- C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5
- IUPAC Name:
- Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Blue FC 05717
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: HC: NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.1 - 3.7 kg
- Housing: individual mesh cages, Type III
- Diet (e.g. ad libitum): ssniff K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- 40 mg in 100 µL
- Duration of treatment / exposure:
- Duration of exposure was 24 h. The treated eye was rinsed with saline solution at the end of the exposure period.
- Observation period (in vivo):
- 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- TEST PROCEDURE
40 mg of the test substance was administered once to the conjunctival sac of the left eye of the rabbits in 100 µL solution. In each case the untreated eye served as a control. 24 h after administration, the treated eye was washed out thoroughly with saline solution.
The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded.
In case of positive findings in the iris and cornea at 24 h and at later evaluation points, one drop of a 1% fluorescein solution was applied to the corneal surfaces, then washed out with saline solution. The eyes were thereafter analysed with UV light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. These effects were linked to mechanical irritation.
- Other effects:
- Slight tear production was seen in one rabbit at the 24 h observation point.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was not considered to be irritating to the rabbit eyes.
- Executive summary:
A study was conducted to assess the eye irritation potential of the test substance in one New Zealand albino female rabbit according to OECD Guideline 405, in compliance with GLP. A single dose of 40 mg test substance was applied to the conjunctival sac of the left eye of the animal in 100 µL solution. The treated eye was washed at 24 h after administration. The untreated eye served as a control. The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded. Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. One rabbit showed light tear production at 24 h. These effects were linked to mechanical irritation and were reversible before end of the study. Under the test conditions, the test substance was not considered to be irritating to the rabbit eyes (Ruf, 1987b).
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