Registration Dossier
Registration Dossier
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EC number: 805-440-4 | CAS number: 22972-51-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-02-13 to 2019-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Reliable study for skin sensitisation using the Guinea Pig Maximisation test method is available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Reliable study for skin sensitisation using the Guinea Pig Maximisation test method is available.
Test material
- Reference substance name:
- (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol
- Cas Number:
- 22972-51-6
- Molecular formula:
- C10H16O
- IUPAC Name:
- (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol
- Test material form:
- liquid
- Details on test material:
- Test item: (1S,4R)-1-Methyl-4-(prop-1-en-2-yl)cyclohex-2-enol
CAS number: 22972-51-6
Physical state: Liquid
Storage: Room temperature
Constituent 1
- Specific details on test material used for the study:
- Test item: (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol (PMDOL)
CAS number: 22972-51-6
Physical state: Liquid
Storage: room temperature
Batch/Lot No.: 118000-182001
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
Source: WEI XIN HANG, Banqiao, Taiwan
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 303-391 grams
- Housing: one guinea pig per cage
- Access to feed: ad libitum
- Water : ad libitum
- Acclimation period: 6 days before start of treatment.
Environmental conditions
Temperature: 22 ± 3 °C
Relative humidity: 50± 20 %
Lighting: 12 hours (06:00 on, 18:00 off)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1mL
- Day(s)/duration:
- 6 days
- Route:
- intradermal
- Vehicle:
- other: Freund's complete adjuvant
- Concentration / amount:
- 0.1 mL
- Day(s)/duration:
- 6 days
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.2 mL
- Day(s)/duration:
- 2 days
Challenge
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 0.2 mL
- Day(s)/duration:
- 1 day
- No. of animals per dose:
- 10 test and 5 negative controls
- Details on study design:
- 1st application: Induction 0.1 mL intradermal
2nd application: Induction 0.2 mL occlusive epicutaneous
3rd application: Challenge 0.1 mL occlusive epicutaneous
Results and discussion
- Positive control results:
- Positive control was performed with Hexyl cinnamic aldehyde in cottonseed oil: 30% of test animals at 24 hours and 40% of test animals at 48 hours after completion of challenge phase respectively.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% v/v in cottonseed
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 mL
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All groups of test article, negative control showed no visible changes on the clipped treatment area. In conclusion, the result indicated that the test article of did not exert delayed skin sensitization in guinea pigs.
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