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Toxicological information

Sensitisation data (human)

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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:
2006
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:
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:
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
Name:
Unnamed
Type:
Constituent
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.).