2,2'-[(2,2',5,5'-tetrachloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]

Sensitisation data (human)

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Reference substance name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]

EC Number:

228-787-8

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]

Cas Number:

6358-85-6

Molecular formula:

C32H26Cl2N6O4

IUPAC Name:

2-[2-(3,3'-dichloro-4'-{2-[2-oxo-1-(phenylcarbamoyl)propyl]diazen-1-yl}-[1,1'-biphenyl]-4-yl)diazen-1-yl]-3-oxo-N-phenylbutanamide

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.