Registration Dossier
Registration Dossier
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EC number: 203-820-9 | CAS number: 110-97-4
Sensitisation data (human)
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- Submission of unpublished data by CTFA.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:
- 1 986
- 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 substance name:
- 1,1'-iminodipropan-2-ol
- EC Number:
- 203-820-9
- EC Name:
- 1,1'-iminodipropan-2-ol
- Cas Number:
- 110-97-4
- Molecular formula:
- C6H15NO2
- IUPAC Name:
- 1,1'-iminodipropan-2-ol
- Details on test material:
- no information provided
Constituent 1
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.
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