Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Allergic contact dermatitis from a perinone-type dye C.I. Solvent Orange 60 in spectacle frames
Author:
Shono M, Kaniwa MA
Year:
1999
Bibliographic source:
Contact Dermatitis, 41, 181-184
Reference Type:
publication
Title:
Allergic contact dermatitis from a perinone-type dye C.I. Solvent Red 179 in spectacle frames
Author:
Tsunoda T, Kaniwa MA, Shono M
Year:
2001
Bibliographic source:
Contact Dermatitis, 45, 166-167
Reference Type:
publication
Title:
Allergic contact dermatitis caused by Solvent Orange 60 dye
Author:
Yeo L, Kuuliala O, White IR, Alto-Korte K
Year:
2011
Bibliographic source:
Contact Dermatitis 64, 353-36
Reference Type:
publication
Title:
Allergic contact dermatitis from solvent orange 60 in spectacle frames
Author:
Isaksson M, Helwig H, Zimerson E, Ryberg K, Hagvall L
Year:
2012
Bibliographic source:
Contact Dermatitis 66 (Suppl.2), 77

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
In case reports the development of dermatitis over the ears was reported after wearing of spectacle frames with earpieces of plastic material containing C.I. Solvent Orange 60. The patients were patch tested and and reacted positive on C.I. Solvent Orange 60. In one case report of a woman working in a plastic manufacturing company the development of dermatitis affecting the wrist, fingers and face was reported. The patient reacted positive in patch tests using C.I. Solvent Orange 60.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
12H-phthaloperin-12-one
EC Number:
230-049-5
EC Name:
12H-phthaloperin-12-one
Cas Number:
6925-69-5
Molecular formula:
C18H10N2O
IUPAC Name:
12H-phthaloperin-12-one

Method

Type of population:
general
occupational
Subjects:
Humans
Route of administration:
dermal
Details on study design:
Patch test

Results and discussion

Results of examinations:
Four patients with contact dermatitis reacted positive in patch tests with C.I. Solvent Orange 60.

Applicant's summary and conclusion

Executive summary:

In case reports the development of dermatitis over the ears was reported after wearing of spectacle frames with earpieces of plastic material containing C.I. Solvent Orange 60. The patients were patch tested and and reacted positive on C.I. Solvent Orange 60. In one case report of a woman working in a plastic manufacturing company the development of dermatitis affecting the wrist, fingers and face was reported. The patient reacted positive in patch tests using C.I. Solvent Orange 60.