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Diss Factsheets
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EC number: 701-246-8 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Vapor Gard
- IUPAC Name:
- Vapor Gard
- Reference substance name:
- Oligomerisation products of beta-pinene
- EC Number:
- 701-246-8
- Molecular formula:
- Variable (dimer = C20-H34)
- IUPAC Name:
- Oligomerisation products of beta-pinene
- Details on test material:
- Typical pinene oligomers content 96 wt%
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: ranged from 2.3 - 2.6 kg
- Housing: Test animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages were changed twice a week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) provided daily
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hour light / 12 hour dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml per site
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Test sites were observed 30-60 minutes, 24h, 48h and 72h after patch removal
- Number of animals:
- 6 animals in total were used in this study (3 male and 3 female).
- Details on study design:
- The dorsal area of each test animal was clipped free of hair 24 hours prior to the application of the test substance. The clipped area was appoximately 10 sq. cm and the skin remained intact.
Each test site received a dose of 0.5 ml and was applied directly onto the skin. The torso was wrapped with semi-occlusive dressing and secured with a non-irritating tape to hold test patches in position and also to reduce evaporation. The test substance was kept in contact with the skin for 4 hours at which point the wrappings were removed and the test sites washed with distilled water to remove any residual test substance.
Observations for skin reactions were recorded 30 - 60 minutes after removal of wrapping and again at 24, 48 and 72 hours. Erythema and oedema were scored accoring to the Draize technique. Skin was also evaluated for necrosis and ulceration or evidence of tissue destruction.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Up to 8 days
- Score:
- 3.58
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Score 1 for 3/6 animals at last observation time
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.17
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.83
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 0.16
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Single animal showed score 1 at last observation time
- Irritant / corrosive response data:
- Erythema: well-defined up to 72h, persisting (slight) in 1/6 rabbits at Day 8. All rabbits showed skin flaking at 8 days.
Oedema: slight/well defined at 30-60 mins, well defined to moderate at 24h, slight/well defined at 48 hours, slight at 72h. Single rabbit slight (acore 1) at 8 days.
Any other information on results incl. tables
Overall 6 rabbit mean of 24 + 48 + 72h erythema/eschar scores = 2.0.
3/6 rabbirs showed persistent (score 1) erythema at the last time of observation.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Mean 24-48-72h erythema/eschar scores 2.0 and 3/6 cases of persistent erythema Criteria used for interpretation of results: EU
- Conclusions:
- Applying EU (DSD and CLP) classification criteria, the study results lead to the conclusion irritating to skin.
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