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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: human data
Adequacy of study:
supporting study
Study period:
no data available
Reliability:
other: not rated acc. to Klimisch
Rationale for reliability incl. deficiencies:
other: Any kind of reliability rating is not considered to be applicable, since human studies/reports are not conducted/reported according to standardised guidelines.

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis due to ammonium bisulfite in a bleaching cream
Author:
Pambor, M.
Year:
1996
Bibliographic source:
Contact Derm., 35, 48-49

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
patch test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hydrogensulfite
EC Number:
231-548-0
EC Name:
Sodium hydrogensulfite
Cas Number:
7631-90-5
Molecular formula:
NaHSO3
IUPAC Name:
sodium hydrogensulfite
Details on test material:
- Name of test material (as cited in study report): sodium bisulfite
No further details are given.

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 1
- Sex: female
- Age: 44 years
No further details are given.
Clinical history:
- Symptoms, onset and progress of the disease: The woman had previous seborrhoeic eczema (1988) and idiopathic urticaria (1992) presented in 1994.
- Exposure history: For several months, she had used a bleaching cream containing 0.45% ammonium bisulfite. 2 days prior to presentation, she had repeated the procedure of bleaching her eyebrows and developed a dermatitis related to the use of this cream, with secondary spread to the ears.
- Aggravating factors both in home and workplace:
With cessation of contact and therapy with topical corticosteroids, ther dermatitis improved.
Controls:
6 control, not further specified
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test):
The woman was patch tested with a standard series (Hermal), the bleaching cream and its individual ingredients. In addition, patch tests were performed with sodium bisulfite (sodium hydrogen sulfite).

ADMINISTRATION
- Type of application: occlusive: 1 day
- Description of patch: The tests were carried out using Finn Chambers and Scanpore tape.
- Vehicle / solvent: water
- Concentrations: 0.45% aq. and 0.1% aq for ammonium bisulfite and 1.0% aq, 0.45% aq and 0.1% aq for sodium bisulfite
- Testing/scoring schedule: Readings were made 1, 2, 3 and 7 days after application.

EXAMINATIONS
No further details are given.

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: see table below

OTHER RESULTS:
Only ammonium bisulfite and sodium bisulfite gave positive reactions in the patient.

Any other information on results incl. tables

Patch test preparation     Results          
    Day 1 Day 2   Day 3  Day 7
 ammonium bisulfite 

0.45% aq. 

0.1% aq.

+

+

+++

+++

+++

+++ 

+

  sodium bisulfite 

1.0% aq. 

0.45% aq.

0.1% aq.

++

-

-

+++

+++

+++

+++

+++

+++

+

+

Applicant's summary and conclusion

Conclusions:
In a standard patch test in one patient, who sufferd from contact dermatitis due to sulfites in a bleaching cream, only ammonium bisulfite and sodium bisulfite gave positive reactions in the patient.