Sandalwood, ext.

Endpoint summary

Description of key information

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

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

Another patch test with 25 human volunteers is reported in areview article, also being negative when tested at 10% concentration in petrolatum (Kligman 1971). However, access to the original study is not available and thus the validity could not be properly assessed - therefore, the finding was rated Klimisch 4 and used as supportive study.

As a study by Fotiades et al. (1995) reported 4 positive sensitisation responses in patch tests and 3 positive responses for photosensitivity in a study investigating 203 patients over more than 7 years, the substance however, in a precautionary approach, is considered a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In a study on 103 human volunteers no cases of skin sensitisation were found. Thus, the substance does not require classification for skin sensitisation according to GHS and/or CLP (Regulation EC No 1272/2008). However, based on a supportive study on 203 patients over 7 years observation, where 4 positive finding in patch tests and 3 positive findings for photosensitisation were made, the substance is precautionary classified as skin senitiser, categroy 1B (H317) according to GHS and CLP.