Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-841-5 | CAS number: 5502-88-5
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.
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.
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.
