Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Data source

Reference

Reference Type:

publication

Title:

Allergic dermatosis and respiratory deseases from reactive dyes.

Author:

Estlander T

Year:

1988

Bibliographic source:

Contact Dermatitis 1988;18:290-297

Materials and methods

Type of sensitisation studied:

respiratory

skin

Study type:

case report

Principles of method if other than guideline:

Occupational case report
Patch-Test, Scratch- or Prick-Test, RAST

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 4-amino-5-hydroxy-3,6-bis[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

EC Number:

241-164-5

EC Name:

Tetrasodium 4-amino-5-hydroxy-3,6-bis[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

Cas Number:

17095-24-8

Molecular formula:

C26H25N5O19S6.4Na

IUPAC Name:

Tetrasodium 4-amino-5-hydroxy-3,6-bis[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

Details on test material:

The test substances were 9 commercial dye powders, brought in from the patients.
Analytical investigation revealed different impurities, amongst others 9 µg/g chromium.

Method

Type of population:

occupational

Subjects:

- Number of subjects exposed: 5
- Sex: 4 male; 1 female
- Age: 24-52 years

Clinical history:

Exposure to reactive dyes before symptoms developed: 8 months to 4 years

Controls:

no data

Route of administration:

other: Patch-Test, Scratch-/Prick-Test, RAST

Results and discussion

Results of examinations:

Patch test: 4 patients with eczema reacted positively to 9 commercial dye powders
2 patients reacted positive to Remazol Schwarz B (1 to 2% in pet). 1 of them was positive in the scratch or prick tests and nasal provocation test, the other one was negative in the scratch or prick tests and RAST.
Scratch and/or prick test: the 2 patients who also had respiratory symptoms and/or urticaria reacted positively to the same dyes as on patch testing
the 5th patient, who had urticaria and respiratory symptoms, reacted positively to Remazol Gold Gelb RNL, but the patch
test with that dye was negative

Applicant's summary and conclusion

Executive summary:

5 cases of occupational eczema, urticaria and respiratory disease from reactive dyes, occurring during 1977-1987, are reported. The patients, 4 men and 1 woman, were 24-52 years old when examined. They had been working in dye houses or textile plants, and had been exposed to reactive dyes for 8 months to 4 years before symptoms developed. Only 1 of the patients has been able to continue in the same occupation. On patch testing, the 4 patients with eczema reacted positively to 9 commercial dye powders. 2 patients reacted to the same dye, Remazol Schwarz B. On scratch and/or prick testing, the 2 patients who also had respiratory symptoms and/or urticaria reacted positively to the same dyes as on patch testing. The 5th patient, who had urticaria and respiratory symptoms, reacted positively to a dye, Remazol Gold Gelb RNL, but the patch test with that dye was negative. None of the patients was patch-test-positive to para-phenylenediamine (PPD) or to textile dye allergens in a series of organic dyes. Thus, the series of organic dyes has little value in the screening of allergy to reactive dyes. A 1% pet. dilution of commercial dye powder for patch testing and the same concentration in distilled water for prick testing seem to be suitable for the screening of allergy to reactive dyes.