Registration Dossier
Registration Dossier
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EC number: 229-245-3 | CAS number: 6448-95-9
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:
- 2004
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Unsuitable test system (patch test instead of intradermal test)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
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:
- 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide
- EC Number:
- 220-509-3
- EC Name:
- 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide
- Cas Number:
- 2786-76-7
- IUPAC Name:
- 4-[(4-carbamoylphenyl)diazenyl]-N-(2-ethoxyphenyl)-3-hydroxy-2-naphthamide
- Details on test material:
- - Name of test material (as cited in study report): Pigment Red 170 (C.I. 12475)
Constituent 1
Method
- Subjects:
- - Number of subjects exposed: 1
- Sex: male
- Age: 30 years
- Race: white (no further information) - Route of exposure:
- other: intradermal
- Reason of exposure:
- intentional
- Exposure assessment:
- not specified
Results and discussion
- Clinical signs:
- - sharply demarcated pruritic lesions in a black and red tattoo on the wrist
- strongly infiltrated and slightly scaly eruptions restricted to the red coloured areas
- symptoms got worse after UV exposure
- lichenoid dermatitis without signs of a granulomatous reaction - Results of examinations:
- patch testing and photo patch testing with used and commercial available azo dye Pigment Red 170 (2.5% pet. and "as is") was negative
Applicant's summary and conclusion
- Conclusions:
- A 30-year old white male showed signs of a lichenoid dermatitis without signs of a granulomatous reaction (strongly infiltrated and slightly scaly eruptions restricted to the red coloured areas of a tattoo, sharply demarcated pruritic lesions). Symptoms got worse after UV exposure. Patch testing and photo patch testing with the used azo dye Pigment Red 170 was negative.
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