Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Patch testing with components of water-based metalworking fluids.
Author:
Greier, J. et al.
Year:
2003
Bibliographic source:
Contact Dermatitis, 49:86-90

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
A clinical trial of 233 dermatitis patients with present or past occupational exposure to metalworking fluids (MWF) were patch tested with MWF including 2-amino-2-ethyl-1,3-propanediol (AEPD).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-amino-2-ethyl-1,3-propanediol (AEPD)
- Analytical purity: 85%

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 233; for AEPD: 160 patients were tested (no further data).
- Sex: male
- Age: 19 to 75 years (mean age of 39.3 years; median: 38 years)
Controls:
MWF allergens (i. a. fragrance mix, colophonium, Balsam of Peru, monoethanolamine, diethanolamine, etc.)
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Description of patch: Patch tests were performed and read according to international guidelines modified by the German Contact Dermatitis Research Group (Schnuch et al., 2001, Leitlinien der Deutschen Dermatologischen Gesellschaft (DDG) zur Durchführung des Epikutantests mit Kontaktallergenen. Hautarzt, 52:864-866).
- Vehicle / solvent: water
- Concentrations: 1% (The test preparation was made from an aqueous stock solution containing the stated concentration of the chemical (85%).)

EXAMINATIONS
- Statistical analysis: Data were analysed at the Information Network of Departments of Dermatology data centre at the University of Göttingen, using the statistical program system SAS 8.2 (SAS Institute, Cary, NC, USA).

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 negative reactions: 159

Any other information on results incl. tables

Only 1 of 160 patients reacted positively to AEPD. This patient did not react to other MWF components, in particular not to monoethanolamine and diethanolamine. Hence, no clincial relevance of the positive test reaction to AEPD could be found. However, not all the MWFs previously used by this patient could be identified. Therefore, previous occupational exposure and relevance could be regarded as possible.

The patient reacted positively to AEPD belongs to a group of metalworkers currently exposed to MWF with work-related hand dermatitis. At the time of patch testing, this patient had been working in the metalworking industry for 2 -20 years.

The importance of AEPD as MWF allergen still remains to be established.

Applicant's summary and conclusion