Registration Dossier
Registration Dossier
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EC number: 219-730-8 | CAS number: 2512-29-0
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Unsuitable test system (patch tests on sensitised humans)
Data source
Reference
- Reference Type:
- publication
- Title:
- Pigmented cosmetic dermatitis and coal tar dyes
- Author:
- Sugai T, Takahashi Y & Takagi T
- Year:
- 1 977
- Bibliographic source:
- Contact Dermatitis 3 (5): 249-256
- Report date:
- 1977
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- other: patch tests with individuals with cosmetics dermatitis
- Principles of method if other than guideline:
- according to recommendations of ICDRG ( International Contact Dermatitis Research Group)
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
Test material
- Reference substance name:
- 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
- EC Number:
- 219-730-8
- EC Name:
- 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
- Cas Number:
- 2512-29-0
- Molecular formula:
- C17H16N4O4
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)diazenyl]-3-oxo-N-phenylbutanamide
- Test material form:
- solid
- Details on test material:
- Hansa yellow,
no information on origin and purity
Constituent 1
Method
- Type of population:
- other: 53 patients with pigmented consmetic dermatitis
- Route of administration:
- dermal
- Details on study design:
- Patch tests and photo patch tests were performed.
Substances were mixed at 5% in polyethylene glycol 400 and polyethylene glycol 6000. Photoirradiation was with UVL (280-355 nm).
Results and discussion
- Results of examinations:
- Hansa Yellow showed only slight reactions (erythema (1 Person) and erythema with edema (1 Person) ), when tested in 38 Persons. The 2 persons reacting to Hansa Yellow showed also reactivity to various other dyes.
1 out of 34 individuals showed slight erythma in the photo patch test.
Applicant's summary and conclusion
- Conclusions:
- Hansa Yellow showed low reactivity in patch tests with individuals (2 of 38) with existing sensitisation to various dyestuffs. No information on purity of the dye used is given.
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