Pine, Pinus mugo, ext.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

January 1999 - February 2000

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific principles, but detailed results and discussion on test item was not reported.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2005

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Skin sensitization was studied in eczema patients with essential oils and fragrance compounds containing Dwarf pine needle oil (2 % pet.).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pine, Pinus mugo, ext.

EC Number:

290-163-6

EC Name:

Pine, Pinus mugo, ext.

Cas Number:

90082-72-7

Molecular formula:

UVCB substance - no molecular formula available.

IUPAC Name:

Pine, Pinus mugo, ext.

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Dwarf pine needle oil (2 % pet.)

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 318 patients
- Sex: Males and females

Clinical history:

- Prior to testing, the patients' history of fragrance allergy was recorded as certain, probable, questionable or none according to previous reports.

Controls:

None

Route of administration:

dermal

Details on study design:

- All fragrance materials were applied to the back for 2 days, using Finn Chambers and Scanpor tape and readings were taken on Days 3 or 4 and 5-7 according to the ICDRG guidelines.
- Fisher's exact test was used to assess associations between prevalences, and the level of significance was chosen at 5 %.

Results and discussion

Results of examinations:

- A total of 318 patients were tested and 16 (5 %) had one or more positive reactions to essential oils (EOS). The 16 persons comprised 13 females and 3 males and their mean age was 45 years.
- Two patients (patient no. 4 and 10) showed positive reactions to Dwarf pine needle oil.

Any other information on results incl. tables

Table 7.10.4/2: Distribution of reactions to individual essential oils and other fragrance compounds in 16 patients positive to at least one of the compounds

 

Fragrance compounds	Numbers of positive reactions
Fragrance mix and ylang-ylang II	6 of each
Ylang-ylang I, sandalwood 10% and spearmint	5 of each
Sandalwood 2%, lemongrass, Narcissus absolute and β -caryophyllene	4 of each
Patchouli, cedarwood and limonene	3 of each
Dwarf pine needle and peppermint	2 of each
Jasmine absolute	1

Applicant's summary and conclusion

Conclusions:

Under the test condition, Dwarf pine needle oil (2 % pet.) induced skin sensitization in two eczema patients.

Executive summary:

Skin sensitization was studied in eczema patients (n=318) with essential oils and fragrance compounds including Dwarf pine needle oil (2 % pet.) among other substances. All fragrance materials were applied to the back for 2 days, using Finn Chambers and Scanpor tape and readings were taken on Days 3 or 4 and 5-7 according to the ICDRG guidelines.

A total of 318 patients were tested and 16 (5 %) had one or more positive reactions to essential oils. The 16 persons comprised 13 females and 3 males and their mean age was 45 years. In this, two patients showed positive reactions to Dwarf pine needle oil.

Under the test condition, Dwarf pine needle oil (2 % pet.) induced skin sensitization in two eczema patients.