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EC number: 207-856-6 | CAS number: 498-15-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well performed study with deviations: no information on age and housing conditions of animals; details on patch material, nature and degree of toxicity, grading system not mentioned
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
- Principles of method if other than guideline:
- The cumulative contact enhancement test (Tsuchiya et al. 1985)
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- Litterature data allow us to classify delta-3-carene as skin sensitiser and the method applied is a non-LLNA method.
Test material
- Reference substance name:
- 3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
- EC Number:
- 236-719-3
- EC Name:
- 3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
- Cas Number:
- 13466-78-9
- Molecular formula:
- C10H16
- IUPAC Name:
- 3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 250-300 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 0%
- Day(s)/duration:
- 10
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 1%
- Day(s)/duration:
- 10
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 3%
- Day(s)/duration:
- 10
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 10%
- Day(s)/duration:
- 10
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 0%
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 1%
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 3%
- No.:
- #4
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Remarks:
- and arachis oil
- Concentration / amount:
- 10%
- No. of animals per dose:
- 12 or 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Four
- Exposure period: 24 hours
- Control group: Vehicle only, olive oil
- Site: Scapular region
- Duration: 10 days with an intradermal injection of Freuds complete adjuvant at the third event followed by an open skin test on day 21.
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- Control group: Vehicle only, arachis oil
- Site: Shaven Flanks
- Concentrations: 10, 3 and 1% - Challenge controls:
- 10 challenge controls
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 12
- Clinical observations:
- Minimum criterion for positive reaction: erythema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 8
- Total no. in group:
- 12
- Clinical observations:
- Minimum criterion for positive reaction: erythema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 8
- Total no. in group:
- 12
- Clinical observations:
- Minimum criterion for positive reaction: erythema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Minimum criterion for positive reaction: erythema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Minimum criterion for positive reaction: erythema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Minimum criterion for positive reaction: erythema
- Reading:
- other: not measured/tested
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- None
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
- Remarks on result:
- not measured/tested
- Reading:
- other: not measured/tested
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- None
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- delta-3-Carene was found to be a skin sensitiser.
- Executive summary:
delta-3 -Carene was tested for skin sensitisation in female Dunkin-Hartley guinea pigs. Groups of guinea pigs (10 or 12/group) received four occluded dermal exposure for 24 hours in scapular region of 50% delta-3-carene followed by challenge dose on the shaven flanks with 10, 3, 1% and vehicle.
In the first set of experiments 8 out of 12 and in second, 7 out of 10 animals showed presence of erythema which was considered as positive reaction.
Therefore, delta-3-carene was found to be a skin sensitiser.
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