Sandalwood, ext.

Skin sensitisation

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

Test material information

Constituent 1

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

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

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

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

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.