Reaction products of 4-amino-5-hydroxynaphthalene-2,7-disulfonic acid, coupled twice with diazotized 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate, sodium salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable publication

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

Materials and methods

Type of sensitisation studied:

skin

Study type:

survey

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Test material form:

not specified

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 1813
- Sex: m/f
- Age: 3-73
- Race: not specified
- Demographic information:
- Other:

Route of administration:

dermal

Results and discussion

Results of examinations:

Black Remazol B Gran: Number of positive results: 2

Applicant's summary and conclusion

Executive summary:

Reactive dyes are used especially for colouring natural fibres (cotton, silk and wool) that are widely used in Western countries, particularly Italy, in the production of clothes. The aim of our study was to investigate sensitization to the most commonly used reactive textile dyes in patients undergoing patch tests, and to assess the clinical relevance of contact sensitization to these dyes. 1813 consecutive patients underwent patch tests with the GIRDCA standard series and an additional textile series of 12 reactive dyes. 18 of these patients were sensitized to reactive dyes (0.99 %) (4 only to reactive dyes). The dyes most frequently responsible for positive patch tests were Red Cibacron CR and Violet Remazol 5R (respectively, 8 and 5 positivities). In 5 cases only was a history of intolerance to particular garments given; of 4 patch tests performed with pieces of garment, 2 were positive. In 1 occupationally-exposed patient, airborne contact dermatitis was suspected. Owing to the lack of up-to-date patch test series, some cases of allergic contact dermatitis from textile dyes are probably misdiagnosed: new colouring agents are continuously introduced to the market, so that a close relationship with textile industry is necessary to improve our diagnostic tools.