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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Fragrance raw materials monographs -alpha-Fenchyl alcohol
Author:
D.L.J. Opdyke
Year:
1979
Bibliographic source:
Food and Cosmetics Toxicology 1979, Pages 384–385

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A Human maximization test of test chemical was conducted on 24 volunteers to assess its skin sensitization potential.
GLP compliance:
not specified
Type of study:
other: Human maximization test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Human maximization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Constituent 1
Chemical structure
Reference substance name:
(1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
Cas Number:
2-tert-butylcyclohexyl acetate
Molecular formula:
C10H18O
IUPAC Name:
(1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
Details on test material:
- IUPAC Name: (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- InChI: 1S/C10H18O/c1-9(2)7-4-5-10(3,6-7)8(9)11/h7-8,11H,4-6H2,1-3H3/t7-,8-,10+/m1/s1
- Smiles: C[C@]12CC[C@H](C1)C(C)(C)[C@H]2O
- Molecular formula: C10H18O
- Molecular weight: 154.253 g/mol
- Substance type: Organic
- Physical state: liquid

In vivo test system

Test animals

Species:
other: Human
Strain:
other: Not applicable
Sex:
female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
4%
Day(s)/duration:
No data available
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4%
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
24
Details on study design:
No data available
Challenge controls:
No data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
No signs of sensitization were observed.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test material was considered to be not sensitizing to the skin of human volunteers.
Executive summary:

A Human maximization test of test chemical was conducted on 24 volunteersto assess its skin sensitization potential.

 

When the chemical was applied at a dose of 4% in petrolatum, none of the treated volunteers had developed any signs of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.