Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
review article or handbook
Title:
Submission of unpublished data by CTFA. Human sensitization and photosensitization evaluation for Monoisopropanolamine (MIPA) and photosensitization evaluation of Diisopropanolamine (DIPA).
Author:
Maibach HI
Year:
1986
Bibliographic source:
Cited in: Anonymous, J.Am.Coll.Toxicol. 6(1), 53-76, 1987
Report Date:
1986

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
according to Draize, J.H. et al.: J. Pharmacol. Exp. Ther. 82, 377-390
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no information provided

Method

Ethical approval:
not specified
Subjects:
25 male and female volunteers
Clinical history:
no data
Controls:
no
Route of administration:
dermal
Details on study design:
see below

Results and discussion

Results of examinations:
DlPA (2% aqueous solution) did not induce allergic or photoallergic dermatitis.

Applicant's summary and conclusion

Conclusions:
DlPA did not induce allergic or photoallergic dermatitis.
Executive summary:

A modification of the Draize repeat insult patch test was used to test a 2% aqueous solution of DlPA for photosensitization. A 0.2 ml volume of the DIPA solution was applied to patches, and the patches were applied to the lower backs of 25 male and female volunteers for 24 h 3 successive days a week for 3 successive weeks. At patch removal, the sites were irradiated with a combination of UV-A and UV-B in a dose of three times the minimal erythema dose. A challenge was performed during week 6, and only UV-A in a nonerythema dose was used. Two patches were applied to the back. One patch remained in place for 24 h and the site was irradiated at patch removal. The other patch remained in place for 48 h and was used to measure contact dermatitis. DlPA did not induce allergic or photoallergic dermatitis.