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Toxicological information

Sensitisation data (human)

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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:
1977
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

Constituent 1
Chemical structure
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

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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