Registration Dossier
Registration Dossier
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EC number: 201-162-7 | CAS number: 78-96-6
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Patch testing with components of water-based metalworking fluids: results of a multicentre study with a second series (2006)
- Author:
- Geier J., et al.
- Year:
- 2 006
- Bibliographic source:
- Contact Dermatitis 2006: 55: 322–329
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Remarks:
- metalworkers exposed to metalworking fluids with suspected occupational dermatitis
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- Wahlberg J E, Lindberg M. Patch testing. In: Contact Dermatitis, 4th edition, Frosch P J, Menné T, Lepoittevin J P (eds): Berlin Heidelberg, Springer, 2006: 365–390.
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- Schnuch A, Aberer W, Agathos M, Brasch J, Frosch P J, Fuchs Th, Richter G; für die Deutsche Kontaktallergie-Gruppe. Leitlinien der Deutschen Dermatologischen Gesellschaft (DDG) zur Durchführung des Epikutantests mit Kontaktallergenen. Hautarzt 2001: 52: 864–866.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1-aminopropan-2-ol
- EC Number:
- 201-162-7
- EC Name:
- 1-aminopropan-2-ol
- Cas Number:
- 78-96-6
- Molecular formula:
- C3H9NO
- IUPAC Name:
- 1-aminopropan-2-ol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Sigma-Aldrich, Schnelldorf, Germany
- Purity: 95%–100% (not further specified)
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 144
- Sex: 135 males, 9 females
- Age: 19 to 62 years, with a mean age of 39.5 years.
- Race: not specified
- Profession: 54 machine operators, 49 metalworkers (not nearer specified), 19 turners, 7 tool makers and 5 grinders, 10 former metalworkers with occupational dermatitis - Clinical history:
- - Symptoms, onset and progress of the disease: 29 (20%) had a past or present atopic dermatitis, 117 patients (81%) hand dermatitis, and in 111 patients (77%), a final diagnosis of occupational dermatitis was stated
- Exposure history: based on their profession, former exposure had to be expected - Controls:
- no
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: not specified; standard series, MWF series
- Description of patch: not specified
- Vehicle / solvent: petrolatum (pet.)
- Concentrations: 2%
- Testing/scoring schedule: based on the guidelines mentioned before
EXAMINATIONS
- Grading/Scoring system: based on the guidelines mentioned before
- Statistical analysis: software: SAS (SAS Institute, Cary, NC, USA), version 8.2
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with strong positive reactions: 0
- Number of subjects with negative reactions: 139
- Number of subjects with equivocal reactions: 4
- Number of subjects with irritating reactions: 0
- percent positive: 0.7
Applicant's summary and conclusion
- Conclusions:
- Similar to the first test series (1% MIPA, 2003), only single positive reactions occurred to MIPA.
It seems that MIPA is a far less important allergen in metalworking fluids.
In a modified Draize test, none of the 150 volunteers could be sensitized by MIPA, applied as 2% aq. solution (Beyer K H Jr, Bergfeld W F, Berndt W O, Carlton W V, Hoffmann D K, Schroeter A L, Shanik R C. Final report on the safety assessment of diisopropanolamine, triisopropanolamine, isopropanolamine, and mixed isopropanolamine. J Am Coll Toxicol 1987: 6: 53–76.).
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