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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Direct observations: clinical cases, poisoning incidents and other

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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:
1991
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

Constituent 1
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

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.