Registration Dossier
Registration Dossier
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EC number: 229-314-8 | CAS number: 6471-50-7
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 1991
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Inflammatory reactions from organic pigments in red tattoos
- Author:
- Bendsoe N, Hansson C, Sterner O
- Year:
- 1 991
- Bibliographic source:
- Acta Dermato-Venereologica 71: 70-73
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- skin sensitisation
Test guideline
- Qualifier:
- no guideline required
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
- EC Number:
- 229-245-3
- EC Name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide
- Cas Number:
- 6448-95-9
- IUPAC Name:
- 3-hydroxy-4-[(2-methyl-5-nitrophenyl)diazenyl]-N-phenyl-2-naphthamide
- Details on test material:
- - Name of test material (as cited in study report): Pigment Red 22 of Devil's Red
Constituent 1
Method
- Subjects:
- - seven patients with inflammatory reactions in red tattoos, no further information
- Route of exposure:
- other: (intra)dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- not specified
Results and discussion
- Clinical signs:
- - immediate local reaction after tattooing followed by a quick-healing, crusted sore
- with a lag time of one month to two years itching and oedema
- inflammatory reaction startet after strong UV-stimulation in 2/3 of the patients
- constant inflammatory reactions in the red areas with periods of exacerbations resembling an acute eczema, tattooed areas became swollen accompanied by severe itching or stinging - Effectivity of medical treatment:
- - excision of the red parts of the tattoos was followed by total healing in all patients
Any other information on results incl. tables
- patch testing with the tattoo pigments (tested as dry, pure substances, no data on purity of test item) gave negative results
- no delayed allergic reactions was found in any patient
- analysis of punch biopsies from the tattoos identified Pigment Red 22 as bright red tattoo pigment
Applicant's summary and conclusion
- Conclusions:
- Inflammatory reactions were observed in seven patients with red tattooed skin, reactions often startet after strong UV-stimulation. Pigment Red 22 was identified as red pigment used for tattooing. Patch testing with the tattoo pigments gave negative results.
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