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Diss Factsheets
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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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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