Registration Dossier
Registration Dossier
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EC number: 209-097-6 | CAS number: 555-43-1
Sensitisation data (human)
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:
- other: Acceptable, well documented publication which meets basic scientific principles.
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:
- 1 990
- 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 tristearate.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerol tristearate
- EC Number:
- 209-097-6
- EC Name:
- Glycerol tristearate
- Cas Number:
- 555-43-1
- Molecular formula:
- C57H110O6
- IUPAC Name:
- 1,3-bis(octadecanoyloxy)propan-2-yl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): tristearate
Constituent 1
Method
- Type of population:
- other: general and occupational
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 9
- Sex: 10 women, 3 men were patch-tested with olive oil. No information given on the 9 of these subsjects tested with tristearate. 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% tristearate were negative.
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