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Diss Factsheets

Toxicological information

Sensitisation data (human)

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Administrative data

sensitisation data (humans)
Type of information:
other: human data
Adequacy of study:
supporting study
Study period:
2004-11-22 to 2004-11-26
other: not rated acc. to Klimisch
Rationale for reliability incl. deficiencies:
other: Well-documented study

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of sensitisation studied:
Study type:
study with volunteers
Test guideline
according to guideline
other: Korting, H.C., Callies, R., Reuch, M., Schlaeger, M., Schöpf, E., Sterry, W. (2001) Dermatologische Qualitätssicherung: Leitlinien und Empfehlungen (2nd Edition), Zuckschwerdt, München, 187 - 192.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): BIO 377


Type of population:
Ethical approval:
confirmed and informed consent free of coercion received
acc. to the declaration of Helsinki (Declaration of Helsinki (2000) 52nd World Medical Assembly, Edinburgh, Scotland.). Information about the study, its objectives, probable benefits, potential risks/troublesome aspects & rights & responsibilities.
- Number of subjects exposed: 50 volunteers
- Sex: males: 4; females: 46
- Age: 19 - 67 years
- Race: Caucasian skin type
Clinical history:
At the beginning of the test, the dermatologist in charge draws up an anamnesis of each volunteer. The results of this skin history act as a basis for the decision of the suitability of the volunteers for the study. Volunteers who had or have cradle cap, allergic rhinitis, allergic asthma or an allergic eczema are identified as atopics (Braun-Falco O., Plewig G., Wolff H. H., (1995) Dermatologie und Venerologie (4th Edition), Springer, Heidelberg, 428 - 430.). In addition, the atopic score is ascertained according to Diepgen et al. (Diepgen T.L., Fartasch M., Harnstein O.P. (1989) Evaluation and relevance of atopic basic and minor features in patients with atopic dermatitis and in the general population Acta Derm. Venereol. Suppl. 144, 50 - 54.) in order to characterize the group of volunteers better (multiple nomination are possible).
According to the anamnesis, volunteers should have healthy skin in the test area and should not take long-term pharmaceuticals which could influence the test results.
Persons who are taking pharmaceuticals that increase the sensibility of the body especially of the skin, pregnant and lactating women, persons who have participated in a patch test during the last three months are excluded from the test.
To standardize the test a blank plaster, demineralized water and two very well tolerated standard products are tested. In addition a positive control, sodium lauryl sulfate (0.3 %) is included in the study.
The vehicle in which the test product is diluted, is tested too.
Standard L is an oil-in-water-emulsion, the second control is Standard N, a water-in-oil-emulsion. Following experiences with these products and according to the grading system (see "Any other information on materials and methods incl. tables" below), overall both standards are rated as very well tolerated.
Route of administration:
Details on study design:
TYPE OF TEST(S) USED: Single patch test-closed (epicutaneous test)

- Type of application: occlusive
- Vehicle / solvent: olive oil
- Concentrations: the test product is appllied in a concentration of 5 % in olive oil on the back of each volunteer under occlusive cutanoeus test plasters (HAL Allergy Test Chambers, Duesseldorf, Germany).
- Testing/scoring schedule: After a period of 48 hours the test patches are removed and the test area is assessed. Further assessments follow after 72 and 96 hours.

- Grading/Scoring system: the grading system to assess the extent of irritation caused by the applied products can be seen below in tabel 1 in "Any other information on materials and methods incl tables"
Very well tolerated test products should not show more reactions than the both standard products.
The assessment of the products depends on the number of irritation point, which is caused by the test product.

Results and discussion

Results of examinations:
Total number of reactions points after 48, 72 and 96 hours:

1. Untreated area
48 hours: 4
72 hours: 0
96 hours: 0

2. Demineralized water
48 hours: 3
72 hours: 0
96 hours: 0

3. Standard L
48 hours: 1
72 hours: 0
96 hours: 0

4. Standard N
48 hours: 1
72 hours: 0
96 hours: 0

5. Sodium lauryl sulphate (0.3 %)
48 hours: 7
72 hours: 37
96 hours: 29

6. Olive oil PN620010, Ch:3 (5 %)
48 hours: 1
72 hours: 0
96 hours: 0

7. BIO 377
48 hours: 0
72 hours: 0
96 hours: 0

Applicant's summary and conclusion

Regarding the assessment of the skin tolerance in the scope of the above described evaluation, test item SymWhite 377 achieves a very good skin compatibility.