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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

Reference
Name:
Unnamed
Type:
Constituent
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.