Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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.