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Diss Factsheets
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EC number: 213-894-4 | CAS number: 1058-92-0
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Mordant Blue 013
- IUPAC Name:
- Mordant Blue 013
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.3 - 3.6 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Humidity: 40 - 60 %
- Photoperiod: 12 hours light / 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml of finely powdered test substance were applied into the conjunctival sac of an eyelid. - Duration of treatment / exposure:
- After application, the eyelids were held together for about 1 second. Treated eye was rinsed after 24 hours with physiological NaCl solution.
- Observation period (in vivo):
- Ocular reactions were evaluated at 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
Cornea - opacity
0 No opacitiy
1 Scaterred or difussed area, details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Opalescent areas, no details of iris visible
4 Opaque, iris invisible
Cornea - area involved
1 One quarter (or less) but not zero
2 Greater than one quarter, but less than half
3 Greater than half, but less than three quarters
4 Greater than three quarters, up to whole area
Iris
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal injection
2 No reaction to light, hemorrhage, gross destruction
Conjuctivae - 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
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
TOOL USED TO ASSESS SCORE: slit-lamp was used to facilitate the evaluation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
Any other information on results incl. tables
Results according to Draize score
animal | obs. | 1h | 24 h | 48 h | 72 h | 7 d | 14 d | 21 d |
1 | cornea | x | 0 | 0 | 0 | 0 | - | - |
iris | x | 0 | 0 | 0 | 0 | - | - | |
conj. redness | x | 0 | 0 | 0 | 0 | - | - | |
conj. chemosis | 1 | 0 | 0 | 0 | 0 | - | - | |
2 | cornea | x | 0 | 0 | 0 | 0 | - | - |
iris | x | 0 | 0 | 0 | 0 | - | - | |
conj. redness | x | 1 | 1 | 1 | 0 | - | - | |
conj. chemosis | 1 | 0 | 0 | 0 | 0 | - | - | |
3 | cornea | x | 0 | 0 | 0 | 0 | - | - |
iris | x | 0 | 0 | 0 | 0 | - | - | |
conj. redness | x | 1 | 1 | 1 | 0 | - | - | |
conj. chemosis | 1 | 0 | 0 | 0 | 0 | - | - |
x = not evaluable (test pattern-related coloring)
- = not examined
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to rabbit eye.
- Executive summary:
Method
Eye irritation potential was assessed following OECD guideline 405. Test substance was applied to one eye of 3 rabbits; the other eye served as control. The eye was rinsed 24 h after application. Observations were done at 1, 24, 48 and 72 h and 7d after application. Observations for effects on cornea, iris and conjunctivae were done up to day 7 after application.
Results
No effects on cornea, iris and conjunctival chemosis were noted; slight effects of conjunctival redness were noted in 2/3 rabbits. Such effects were fully reversible within 7 days.
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