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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Olive oil as a cause of contact allergy in patients with venous eczema, and occupationally
Author:
Malmkvist Padoan, S. et al.
Year:
1990
Bibliographic source:
Contact dermatitis 23: 73-76

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
13 cases of contact allergy to olive oil were identified in a hospital in sweden. Nine of these patients were patch-tested with known components of olive oil. Among these components was triolein.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): triolein

Method

Type of population:
other: general and occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 13 exposed to olive oil, 9 exposed to triolein
- Sex: 10 women, 3 men were patch-tested with olive oil. No information given on the 9 of these subsjects tested with triolein. 2 persons were professional pedicurists.
- Age: 33 to 82 (median age of 68)
Clinical history:
- History of allergy or casuistics for study subject or populations: 9 patients with venous insufficiency and eczema, 2 of these had developed a generalized spread of their eczema; of the 4 remaining patients, 2 had hand eczema, one of whom also had leg eczema without venous insufficiency; 1 patient had atopic dermatitis and 1 leg eczema with arterial, but not venous, insufficiency
- Exposure history: Patients with positive patch test reactions to olive oil were investigated.
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn Chamber (Epitest Oy, Hyryla, Finland), secured with Scanpor tape (Norgesplaster A/S, Venesla, Norway)
- Concentrations: 30%
- Testing/scoring schedule: Removal after 48 h, reading after 72 h
- Removal of test substance: Yes

EXAMINATIONS
- Grading/Scoring system: according to ICDRG recommendations (Fregert and Bandmann, 1975)

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/9
- Number of subjects with negative reactions: 9/9

Applicant's summary and conclusion

Conclusions:
Occlusive patch tests on patients with 30% triolein were negative.