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EC number: 485-260-7 | CAS number: 927395-20-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted at GLP-accredited facility to current guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
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 (incl. QA statement)
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: an accredited supplier, but otherwise not stated
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet, ad libitum
- Water (e.g. ad libitum): mains tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 7 March 2007 To: 14 March 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- observations made 1, 24, 48 and 72 hours, and 7 days after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 0.5 ml applied under 2.5cm x 2.5cm cotton gauze patch
- Type of wrap if used: cotton gauze, surgical tape, elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton woll soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: eryhtema/eshar - 0-4, oedema - 0-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 65962 male
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 65962 male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 65962 male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 65962 male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 24h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 65961 male
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 65961 male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 65961 male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 65961 male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 24h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 65960 male
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 65960 male
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 65962 male
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 65962 male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 65962 male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 65962 male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 24h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 65961 male
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 65961 male
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- probability of mild irritation
- Remarks:
- Loss of skin elasticity
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 65961 male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 65961 male
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 24h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 65960 male
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: animal showed slight desquamation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 65960 male
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 65960 male
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 65960 male
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 24h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 65960 male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 24h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 65960 male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48h
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Not classified for skin irritation according to EU DSD/DPD or CLP criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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