Registration Dossier
Registration Dossier
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EC number: 233-469-7 | CAS number: 10192-30-0
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:
- Ammonium bisulfite contact dermatitis: face exzema due to a bleaching ointment used during hair-dying
- Author:
- Nassif, A.
- Year:
- 2 006
- 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
- Reference substance name:
- ammonium bisulfite
- IUPAC Name:
- ammonium bisulfite
- 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
Constituent 1
Constituent 2
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.
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