Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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 report of test substance
Author:
D.L.J. Opdyke
Year:
1979
Bibliographic source:
Food and Cosmetics Toxicology 1979

Materials and methods

Test guideline
Qualifier:
according to
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:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
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 group
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

In vivo (LLNA)

Cellular proliferation data / Observations:
No signs of sensitization were observed.

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.

 

None of the volunteers had developed any signs of skin sensitization. Hence the test chemical wasconsidered to be not sensitizing to theskin of human volunteers.