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EC number: 479-880-7 | CAS number: 97042-18-7
- 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
- Study period:
- 10 June to 19 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- BPS-MAE
- IUPAC Name:
- BPS-MAE
- Test material form:
- other: white shiny solid
- Details on test material:
- - Name of test material (as cited in study report): BPS-MAE
- Physical state: White shiny solid
- Lot/batch No.: G130324
- Storage condition of test material: Room temperature in the dark.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Commercila laboratory animal supplier.
- Age at study initiation: 12 to 20 weks
- Weight at study initiation: 2.0 to 3.5kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: Free access to food (Certified Rabbit Diet (Code 5322) supplied by International Product Supplies Limited, Wellingborough, Northants, UK) was allowed throughout the study.
- Water: Free access to mains drinking water was allowed throughout the study.
- Acclimation period: >= 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°C
- Humidity: 30 to 70%
- Air changes: The rate of air exchange was at least fifteen changes per hour
- Photoperiod: the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1ml - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure:
SCORING SYSTEM:
The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A+ B+C)x2
Score for iris = Dx5
Score for cornea = (ExF)x5
TOOL USED TO ASSESS SCORE:Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 1 days
- Other effects:
- Minimal conjunctival irritation was noted in all treated
eyes one hour after treatment.
All treated eyes appeared normal at the 24-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 2.7 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 criteria for classification as irritant according to ED labelling regulations Commission Directive 200I/59/EC.
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