Sodium hydrogensulfite

Sensitisation data (human)

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

Test material information

Constituent 1

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.