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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
Ammonium bisulfite contact dermatitis: face exzema due to a bleaching ointment used during hair-dying
Author:
Nassif, A.
Year:
2006
Bibliographic source:
Contact derm., 55, 124

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
ammonium bisulfite
IUPAC Name:
ammonium bisulfite
Constituent 2
Chemical structure
Reference substance name:
Ammonium hydrogensulphite
EC Number:
233-469-7
EC Name:
Ammonium hydrogensulphite
Cas Number:
10192-30-0
Molecular formula:
NH5SO3
IUPAC Name:
ammonium hydrogensulfite
Details on test material:
- Name of test material (as cited in study report): ammonium bisulfite

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 1
- Sex: female
- Age: 41 years old
Clinical history:
The face of a 41-year-old woman with previous personal allergic rhinitis, who used to dye her hair with henna for many years without problems, started itching one time while she was still at the hair dresser. 24 hours later she noticed itching and erythema over her forehead and temples and next day over her cheeks.
Controls:
no
Route of administration:
dermal
Details on study design:
After a 3-week course of steroid ointment, she was patch tested with a suspicion of contact dermatitis to the hair-dye. She was tested (with Curatest) to European standard tray, a preservative and diluent series and the two ointments that had been used by the hairdresser. A 48-hours and a late reading was performed.

Results and discussion

Results of examinations:
Both readings demonstrated a negative PPD test but a positive test (+++/++) to the Colour Bleaching Ointment Preguard Wella. Subsequent patch-testing to the ingredients of the ointment identified ammonium bisulfite (2% in pet.) as the responsible allergen with a ++/++ positivity at both readings.

Applicant's summary and conclusion

Conclusions:
Patch-testing to the ingredients of an ointment identified ammonium bisulfite (2% in pet.) as the responsible allergen in a 41-year-old woman.