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EC number: 458-890-5 | CAS number: 2138848-94-7
- 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:
- other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 458-890-5
- EC Name:
- -
- Cas Number:
- 2138848-94-7
- Molecular formula:
- C35H31N8O18S3.xNa.yK, where x+y=3
- IUPAC Name:
- dipotassium sodium 3-[(1E)-2-{4-[(1E)-2-{4-[(1E)-2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]-2-sulfonatophenyl}diazen-1-yl]-2,5-bis(2-hydroxyethoxy)phenyl}diazen-1-yl]-4,5-dihydroxynaphthalene-2,7-disulfonate
- Details on test material:
- Nature of substance: Black granular solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animals were in the weight range of 2.0 to 3.5 kg and were twelve to twenty weeks old. After an acc1imatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label. The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) supplied by BCM IPS Limited, London, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Test susbtance administred as powder
- Controls:
- no
- Amount / concentration applied:
- 0.1 ML (92mg)
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 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: 1, 24, 48 and 72 h
- Score:
- 0.75
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0.75
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0.75
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0.75
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0.75
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0.75
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 2 days
- Other effects:
- Black coloured staining of the fur was noted around all treated eyes throughout the study. Grade 1 chemosis and redness in all treated eyes at the 24- hour observation. All treated eyes appeared normal at the 48-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maXImum group mean score of 12.0 and was classified as a MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the critera for classification as an eye irritant according to EU labelling regulations Commission Directive 2001/59/EC or Regulation (EC) No 1272/2008 [CLP/GHS]
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