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Diss Factsheets
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EC number: 407-420-7 | 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:
- Apr, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted equivalent or similar to EU Method B.5. and OECD Guideline 405 in compliance with GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): H112323
- Physical state: Dark blue powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK
- Age at study initiation: 15-24 wk
- Weight at study initiation: 4266-4412 g
- Housing: Housed individually in anodised aluminium sheet cages
- Diet (e.g. ad libitum): Labsure CRB Rabbit Diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 1-2 h, Day 1, 2 , 3, 4, 6 and 7 of application
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scale to assess the grade of ocular reaction and A modified form of the Kay and Calandra system was used to interpret and classify the numerical scores. As an aid in the assessment of corneal damage, fluorescein staining was used at the 1, 2 (2 animals), 3, 4, 6 and 7-d readings.
TOOL USED TO ASSESS SCORE: Fluorescein staining
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Redness could not be fully assessed due to staining of the cornea but is unlikely to have occurred
- Irritant / corrosive response data:
- Application of the test sample into the conjunctival sac of the eye of one rabbit caused moderate initial pain (class 3 on a 0-5 scale). The eyes of the remaining rabbits were treated with a local anaesthetic prior to application and these animals showed no initial pain following application.
Apart from blue staining of the periorbital tissues by the test sample, there were no corneal or iridial effects. Blue staining of the conjunctiva by the test sample obscured any underlying redness which may have been present. However as the conjunctival effects were limited to a severe, but transient, discharge in one animal and an intermittent slight discharge in another animal, it is considered unlikely that significant redness was present in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance was considered to be not irritant to the rabbit eye
- Executive summary:
A study was conducted to assess the eye irritation potential of test substance to the rabbit eye equivalent or similar to EU Method B.5. and OECD Guideline 405 in compliance with GLP.
Instillation of the undiluted test sample into the conjunctival sac of the eye of one rabbit caused moderate initial pain (class 3 on a 0-5 scale). The eyes of the other two rabbits were therefore treated with a local anaesthetic prior to dosing and these animals showed no initial pain following application.
Apart from blue staining of the periorbital tissues by the test sample, there were no corneal or iridial effects. Blue staining of the conjunctiva by the test substance obscured any underlying redness that may have been present. However, as the observed ocular effects were limited to transient/intermittent conjunctival discharge it is considered unlikely that significant conjunctival redness was present in any of the animals.
As the staining is limited to the conjunctiva and no corneal effects occurred It is hence concluded that the test substance has no irritating effects on the rabbit eye.
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