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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:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Reason / purpose for cross-reference:
reference to same study
Type of sensitisation studied:
skin
Study type:
not specified
Principles of method if other than guideline:
Patch test
GLP compliance:
not specified
Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 3123
- Sex: Not specified
- Age: Not specified
- Race: Not specified
- Demographic information: Not specified
Clinical history:
Patients with cosmetic dermatitis
Controls:
Not specified
Route of administration:
dermal
Details on study design:
Patch test / 2% in petrolatum
Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 47
- Number of subjects with negative reactions: 3076
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Executive summary:

Patch testing of 3123 patients with cosmetic dermatitis to 2% Santalol in petrolatum resulted in 47 positive reactions (incidence = 1.5%).

Data source

Reference
Reference Type:
review article or handbook
Title:
A toxicologic and dermatologic assessment of cyclic and non-cyclic terpene alcohols when used as fragrance ingredients
Author:
The RIFM EXPERT Panel (D. Belsito a, D. Bickers b, M. Bruze c, P. Calow d, H. Greim e, J.M. Hanifin f, A.E. Rogers g, J.H. Saurat h, I.G. Sipes i, H. Tagami)
Year:
2008
Bibliographic source:
Food and Chemical Toxicology 46:S1-S71

Materials and methods

Principles of method if other than guideline:
This report summarizes safety data relevant to the risk assessment of the use of some cyclic and non-cyclic terpene alcohols as fragrance ingredients.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Studies performed before the adoption of the LLNA test method

Test material

Constituent 1
Chemical structure
Reference substance name:
5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
EC Number:
204-102-8
EC Name:
5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
Cas Number:
115-71-9
Molecular formula:
C15H24O
IUPAC Name:
5-(2,3-dimethyltricyclo[2.2.1.0~2,6~]hept-3-yl)-2-methylpent-2-en-1-ol
Constituent 2
Chemical structure
Reference substance name:
[1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
EC Number:
201-027-2
EC Name:
[1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
Cas Number:
77-42-9
Molecular formula:
C15H24O
IUPAC Name:
2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)pent-2-en-1-ol
Test material form:
not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: not specified
Vehicle:
not specified
Concentration / amount:
10 %
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: not specified
Vehicle:
not specified
Concentration / amount:
10 %
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
not specified
Details on study design:
not specified
Challenge controls:
Not included.
Positive control substance(s):
yes
Remarks:
Several substances were tested in parallel. Alpha-hexyl cinnamic aldehyde results were included in this ESR as it is one of the preferred positive control substance for GPMT tests.

Results and discussion

Positive control results:
See Results table

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
10%
No. with + reactions:
64
Total no. in group:
100
Clinical observations:
not specified
Remarks on result:
positive indication of skin sensitisation
Remarks:
Mild sensitizer: Category II, 29-64% of animals with + reactions (No. with + reactions & total number in group not reported))
Key result
Reading:
1st reading
Group:
positive control
Dose level:
10%
No. with + reactions:
80
Total no. in group:
100
Remarks on result:
positive indication of skin sensitisation
Remarks:
Strong sensitizer: Category IV, 65-80% of animals with + reactions (No. with + reactions & total number in group not reported))

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Santalol was allergenic in animals.
Executive summary:

Santalol was reported to be positive in a guinea-pig maximisation test when tested at 10 %.