Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
year of publication: 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, sufficiently documented publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Sensitization to azo dyes: negative patch tests to yellow and red azo dyes in printed paper
Author:
Thierbach MAC, Geursen-Reitsma AM, van Joost, TH
Year:
1992
Bibliographic source:
Contact Dermatitis 27: 22-26
Report Date:
1992
Reference Type:
publication
Title:
Terminology of contact dermatitis
Author:
Wilkinson DS, Fregert S, Magnusson B, Bandmann HJ, Calnan CD, Cronin E, Hjorth N, Maibach HJ, Malten KE, Meneghini CL, Pirilä V
Year:
1970
Bibliographic source:
Acta Dermatovener 50: 287-292
Report Date:
1970

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human Patch Test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: other: patients with a presumable allergic contact dermatitis
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 32
- Sex: 20 women, 12 men
- Mean Age: 39.9 years (women); 46.6 years (men)

- Other:
- all with a positive patch test reaction to p-aminoazobenzene (0.25% pet)
- 11 patients had previously also shown sensitization to para-phenylenediamine (PPD)
- 10 patiens were negative to all the test allergens of the European standard series
- 12 of the 32 cases showed (allergic) hand dermatitis
Controls:
- 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and to PPD

Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Vehicle / solvent: yellow petrolatum
- Concentrations: 2%

Results and discussion

Results of examinations:
- the test item did not elicit a positive patch test reaction in any of the 32 patients nor in the 30 controls

Applicant's summary and conclusion

Conclusions:
The test item (2% P.Y. 12 in yellow petrolatum) did not elicit a positive patch test reactions in any of the 32 patients (with allergic contact dermatitis and a positive patch test reaction to p-aminoazobenzene) or control subjects (patients with an allergic contact dermatitis but negative to p-aminoazobenzene and para-phylenediamine).
Executive summary:

Patch tests were performed with 32 patients with allergic contact dermatitis and a positive patch test reaction to p-aminoazobenzene. Thirty patients with an allergic contact dermatitis but negative to p-aminoazobenzene and para-phylenediamine served as control group. The test item (2% P.Y. 12 in yellow petrolatum) did not elicit a positive patch test reactions in any of the patients or control subjects.