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EC number: 219-943-6 | CAS number: 2580-56-5
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Reliability 4 has been assigned due to the lack of information on the composition of test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Based on: Federal Register 38 no. 187, 1550.42 (eye), S. 27019, 27.09.73
- GLP compliance:
- no
Test material
- Reference substance name:
- Basic Blue 026 chloride
- IUPAC Name:
- Basic Blue 026 chloride
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cages without litter
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: > 3 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 h light / 12 h dark
Test system
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml of solution or 100 mg of powder.
- Duration of treatment / exposure:
- No rinsing of the eye.
- Observation period (in vivo):
- 1h, 24 h, 48 h, 72 h up to 7 days after application.
- Number of animals or in vitro replicates:
- 6.
- Details on study design:
- SCORING SYSTEM: Draize
Cornea opacity
0 no opacity
1 scattered or diffuse area, details of iris clearly visible
2 easily discernible translucent areas, details of iris slightly obscured
3 opalescent areas, no details of iris visible, size of pupil barely discernible
4 opaque, iris invisible
Iris
0 normal
1 folds above normal, congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, hemorrhage, gross destruction (any or all of these)
Conjunctivae redness
0 vessels normal
1 vessels definitely injected above normal
2 more diffuse, deeper crimson red, individual vessels not easily discernible
3 diffuse beefy red
Conjunctivae chemosis
0 no swelling
1 any swelling above normal (includes nictitating membrane)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half closed
4 swelling with lids about half closed to completely closed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- due to substance colour
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 5 rabbits
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2.7
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 3.7
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 3.3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- due to severe swelling and gluing of the eye with suppurative mucus.
- Other effects:
- 1 h after application of the test substance in all rabbits strong swelling of the conjunctivae and strong secretion on the treated eyes. Cornea was not evaluated after 1 h, as the entire eye turns blue-black due to test substance.
Up to 48 h after application in all rabbits hardened nickel skin. After 72 h at 1 rabbit small bleeding at the lower lid margin. 72 h after application until the end of the observation period (7 d), the eyes were covered or glued with purulent mucus in all rabbits. 48 h to 7 d after application hairs at the lower lid margin approx. 4 cm firmly bound with substance and pus.
The pathological findings on the eye and the irritation of the mucous membrane were not reversible within 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- other: irreversible effects on eye - cat. 1 according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Irreversible effects in the eye of rabbits.
- Executive summary:
Method
A study on 6 rabbits was conducted to assess the eye irritation potential of test substance, by application of test substance in one eye. The other eye served as control. No rinsing of the eye was performed and assessment was performed 1 h, 24 h, 48 h, 72 h up to 7 d after instillation. Effects of corneal opacity, conjunctivae redness and chemosis and effects on iris were scored according to Draize scale.
Results
Due to substance-induced colouring, it was not possible to assess redness of the ocular mucosa. Severe effects on iris, cornea (opacity) and conjuctivae (chemosis) were evident in all animals. Pathological findings on eye and irritation of mucous membrane were not reversible within 7 days.
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