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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
Human data
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, published by The Association of Food and Drug Officials of The United States, 1965 (modified).
GLP compliance:
no
Remarks:
GLP is not applicable to studies on human volunters. The study had been inspected and audited by the Quality Assurance Unit with reference to CFR Title 21 Part 56, Subparts A - D and the Institutional Review Board (IRB) of AMA Laboratories, Inc.
Type of study:
patch test
Justification for non-LLNA method:
Human data available

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
Constituent 3
Chemical structure
Reference substance name:
(Z)-5-[(6R)-4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl]-2-methylpent-2-en-1-ol
Cas Number:
176777-61-0
Molecular formula:
C15H24O
IUPAC Name:
(Z)-5-[(6R)-4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl]-2-methylpent-2-en-1-ol
Constituent 4
Chemical structure
Reference substance name:
(E)-(R)-(+)-5-(2,3-dimethyltricyclo[2.2.1.0^2,6]hept-3-yl)-2-methyl-2-penten-1-ol
Cas Number:
14490-17-6
Molecular formula:
C15H24O
IUPAC Name:
(E)-(R)-(+)-5-(2,3-dimethyltricyclo[2.2.1.0^2,6]hept-3-yl)-2-methyl-2-penten-1-ol
Constituent 5
Chemical structure
Reference substance name:
2-​Hepten-​1-​ol, 2-​methyl-​6-​(4-​methylphenyl)​-​, (2Z)​-
Cas Number:
122442-36-8
Molecular formula:
C15H22O
IUPAC Name:
2-​Hepten-​1-​ol, 2-​methyl-​6-​(4-​methylphenyl)​-​, (2Z)​-
Test material form:
liquid

In vivo test system

Test animals

Species:
other: Human
Sex:
male/female
Details on test animals and environmental conditions:
Number of subjects enrolled 103
Number of subjects completing study 100
Age Range 19 - 67
Sex Male 13
Female 90
Race Caucasian 85
Hispanic 15
Asian 3

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Clinical observations:
no adverse effects
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material, when tested under semi-occlusion as described herein, may be considered a NON-PRIMARY SENSITIZER to the skin according to the reference.
Executive summary:

A patch test on voulnteers has been conducted on sandalwood oil.

The test material, when tested under semi-occlusion as described herein, may be considered a NON-PRIMARY SENSITIZER to the skin according to the reference.

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