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Toxicological information

Sensitisation data (human)

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Administrative data

sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well described.

Data source

Reference Type:
Contact allergy to balsam of Peru. II. Patch test results in 102 patients with selected balsam of Peru.
Hausen BM
Bibliographic source:
American Journal of Contact Dermatitis, 12(2), 93-102

Materials and methods

Type of sensitisation studied:
Study type:
study with volunteers
Test guideline
no guideline available
Principles of method if other than guideline:
Patch test
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
Purchased from pharmaceutical companies, no more data.


Type of population:
Ethical approval:
other: patients chose to participate to this study
- Number of subjects exposed: 102
- Sex: 32 men and 70 women
- Age: from 18 to 88 years old
- Race: European
- Demographic information:
- Other: Details were given on 25 selected patients with particular habits (patient number, sex, age, profession, site of skin lesions / symptoms, if positive reactions to Balsam of Peru (BP) or Fragance Mix (FM) or propolis (PO), if they have positive reaction with one or more contituents of BP, if positive reactions with other allergens, individual habits, possible etiologies, and then comments/remarks).
Clinical history:
In a previous study, the main contact sensitizers in Balsam of Peru (BP) were identified and a series of 20 compounds, the BP series, was established.
From 1995 to 1998, 2273 patients with contact dermatitis were tested with the standard series, which include BP.
Out of 445 patients positive for BP, 102 individuals were agreed to participate in an additionnal test with BP series.
Route of administration:
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

- Type of application: occlusive
- Description of patch: patch tests with substance to test were applied to the backs of the patients for 24 hours using Finchamber on Scanpor (Epitest, Finland) and self-adhesive tape (Mefix, Mölnlycke, Sweden).
- Vehicle / solvent: none
- Concentrations: 5%
- Volume applied: no data
- Testing/scoring schedule: application during 24hours
- Removal of test substance: none

- Grading/Scoring system: Readings were done 24 and 72 hours according to the rules of the International Contact Dermatitis Research Group (ICDRG).
- Statistical analysis: none
- Other: only the 72-hour readings were used for evaluation.

Results and discussion

Results of examinations:
Of these 102 patients, 44 were positive to BP alone and negative to fragance mix (FM) and propolis (PO). Simultaneous reactions to BP and FM occured in 49 cases. A combined response to BP, FM and PO was seen in 5 individuals, and 4 patients reacted only to BP and PO but not to FM.
Skin lesions were observed at the following sites:
- eczema of the face, neck and décolleté: 25 cases;
- hands: 25 cases;
- trunk or whole body: 10 cases;
- hands and feet: 7 cases;
- vulva and/or genitals: 7 cases;
- feet alone: 6 cases;
- shin bones: 5 cases;
- thighs: 3 cases;
- forearms/wrists: 2 cases
Ulcus cruris was seen in 10 patients, urticaria and Quincke's edema in 5, atopic eczema in 3, and psoriasis vulgaris and eczema nummulare in 1 patient.
Of the 102 patients tested with the BP series, 93 reacted to 1 or more compounds, and 9 patients with a positive reaction to BP were negative to all 20 compounds of the BP series.
There were NO positive reaction with Vanillin.

Applicant's summary and conclusion

Vanillin was negative in Patch test on patients who have positive reactions with Balsam of Peru.