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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 June to 07 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- BPS-MAE
- IUPAC Name:
- BPS-MAE
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 12 to 20 weeks
- 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Distilled water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Approximately one hour following the removal of the patches, and 24,48 and 72 hours later, the test sites were examined for evidence of primary irritation
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: No data
- % coverage:
- Type of wrap if used: Cotton gauze patch secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration ofthe exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme
The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Other effects:
- No evidence of skin irritation was noted during the study.
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 primary irritation index of 0.0 and was classified as - NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
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