Registration Dossier

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:
1980
Bibliographic source:
Contact Dermatitis 6: 330-336.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
1% C.I. Pigment Red 3 in petrolatum

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).