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EC number: 226-841-5 | CAS number: 5502-88-5
- 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:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guideline study conducted in a GLP laboratory prior to the acceptance of the LLNA.
Test material
- Reference substance name:
- 4-isopropyl-1-methylcyclohexene
- EC Number:
- 226-841-5
- EC Name:
- 4-isopropyl-1-methylcyclohexene
- Cas Number:
- 5502-88-5
- Molecular formula:
- C10H18
- IUPAC Name:
- 1-methyl-4-(propan-2-yl)cyclohex-1-ene
- Reference substance name:
- rel-(1R,4R)-1-isopropyl-4-methylcyclohexane
- Cas Number:
- 1678-82-6
- Molecular formula:
- C10H20
- IUPAC Name:
- rel-(1R,4R)-1-isopropyl-4-methylcyclohexane
- Reference substance name:
- rel-(1S,4S)-1-isopropyl-4-methylcyclohexane
- Cas Number:
- 6069-98-3
- Molecular formula:
- C10H20
- IUPAC Name:
- rel-(1S,4S)-1-isopropyl-4-methylcyclohexane
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- Yellow liquid.
Batch 250992.
Stored in the fridge at 2-8'C.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- 5 days acclimatisation.
Randon allocation to groups.
Cages: 48x61x25 cm.
Housed 5 to a cage.
Temperature: 19-21'C.
Humidity: 62%.
15-20 air changes per hour.
Diet: Special Diets Services Ltd, ad libitum.
Water: Domestic supply.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- 5%, 50%
- Day(s)/duration:
- 2 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- maize oil
- Concentration / amount:
- 10%
- Day(s)/duration:
- 24h and 48h.
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Control animals: 5 animals.
Test Group: 10 animals. - Details on study design:
- Hair clipped from an area 4cm x 6cm.
The following day each animal was treated with 6 intradermal injections.
Six days later, the hair was clipped across the scapular region.
The folowing day each animal was treated with one topical application to the scapular region under a Webril patch.
The patched were covered with aluminium foil and then Blenderm occlusive tape.
The patched were removed after 48 hours.
The challenge and rechallenge:
Thirteen days after the application the animals were clipped.
The animals treated with test material to the left and right flanks.
The patched were covered for 24 hours.
The folowing day each animal was treated with 2 concentrations of the test material. - Challenge controls:
- 0.5 ml volume of the vehicle.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- The most recent positive control was completed in April 1996 with MBT at a concentration of 25% in maize oil.
100% of these animals gave positive reactions.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight skin irritation
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight skin irritation
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not a skin sensitisation according to the current OECD guidance.
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