Registration Dossier
Registration Dossier
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EC number: 219-372-2 | CAS number: 2425-85-6
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Pigmented contact dermatitis from azo dyes. I. Cross-sensitivity in humans
- Author:
- Kgzuka T, Tashiro M, Sano S, Fujimoto K, Nakamura Y, Hashimoto S, Nakaminami G.
- Year:
- 1 980
- Bibliographic source:
- Contact Dermatitis 6: 330-336.
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test material
- Reference substance name:
- 1-(4-methyl-2-nitrophenylazo)-2-naphthol
- EC Number:
- 219-372-2
- EC Name:
- 1-(4-methyl-2-nitrophenylazo)-2-naphthol
- Cas Number:
- 2425-85-6
- Molecular formula:
- C17H13N3O3
- IUPAC Name:
- 1-(4-methyl-2-nitrophenylazo)-2-naphthol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- 1% C.I. Pigment Red 3 in petrolatum
Constituent 1
Method
- Type of population:
- other: 28 healthy young female volunteers
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- No skin reactions
Applicant's summary and conclusion
- Conclusions:
- No skin reactions were seen in 28 healthy young female volunteers in a 48 hour patch test with 1% C.I. Pigment Red 3 in petrolatum (Kgzuka et al.1980).
- Executive summary:
Slight erythema or erythema with edema were observed in patients with pigmented cosmetic dermatitis in patch or photopatch tests with C.I. Pigment Red 3 after application for 48 or 72 hours. Positive reactivity was 34.2% (13/38) (Sugai et al.1977). The reddening and swelling of the skin were seen in five of 155 patients with cosmetic dermatitis in a 48-h path tests with 5% C.I. Pigment Red 3 in polyethylene glycol; slight reddening was seen in another 25 of the patients (MJCDRG 1978). In a patch test, negative reaction was observed with 1% Pigment Red 3 (in petrolatum) in the skin of patients who were suffered from dermatitis caused by Brilliant Lake Red R. No skin reactions were seen in 28 healthy young female volunteers in a 48 hour patch test with 1% C.I. Pigment Red 3 in petrolatum (Kgzuka et al.1980).
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