Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: Case report

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented publication according scientific principles

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1992

Report date:

1991

Materials and methods

Type of sensitisation studied:

respiratory

Study type:

case report

Principles of method if other than guideline:

The patient was skin tested with four reactives dyes. Open and subsequently occlusive patch tests were performed with 1 % dilution in normal saline. Prick tests were executed with progressively more concentrated (1:20,000; 1:2,00; 1:200) dye solution in Coca's vehicle.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

EC Number:

274-499-0

EC Name:

Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

Cas Number:

70247-70-0

Molecular formula:

C19H14BrCl2N5O8S2.2Na

IUPAC Name:

disodium 4-[4-({5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Method

Type of population:

occupational

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: one
- Sex: Male
- Age: 38
- Race: White
- Other: ex smoker

Controls:

no control

Route of administration:

inhalation

Results and discussion

Results of examinations:

Positive reaction at patch test with erythema, edema, blistering, and at prick test with wheals having a diameter of 0.5 and 1 mm, 1.5 times teh histamine wheal at the 3 aforementioned dilutions.

Applicant's summary and conclusion

Conclusions:

The subsance has been identified as being responsible for respiratory sensitisation.

Executive summary:

A case of occupational asthma in a wool and cotton dyer handling reactive dyes is described. The patient was skin positive, but asymptomatic to house dust mites. A bromoacrilamidic dye (Lanasol Yellow 4G) has been identified through chamber inhalation challenge as being responsible for the sensitization. A very short (4-minute) exposure produced a severe immediate obstructive ventilatory defect followed by arterial hypotension and urticaria. Bronchial hyperresponsiveness as tested through metacholine challenge was absent both in basal conditions and after the dye challenge. Both prick and patch test for the dye were positive in the absence of any sign of contact dermatitis.