Registration Dossier

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:
2019

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

Constituent 1
Chemical structure
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
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.