Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Method not validated

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
An attempt to improve diagnostics of contact allergy due to epoxy resin systems. First results of the multicentre study EPOX 2002
Author:
Geier, J.; Lessmann, H.; Hillen, U.; Jappe, U.; Dickel, H.; Koch, P.; Frosch, P.J.; Schnuch, A.; Uter, W.
Year:
2004
Bibliographic source:
Contact Dermatitis, 51, 263-272
Reference Type:
grey literature
Title:
Unnamed
Year:
2012

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: Multi-center study: patch testing of patients with suspected contact allergy due to epoxy resin systems
Principles of method if other than guideline:
patch testing of patients with suspected contact allergy due to epoxy resin systems
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-Diaminocyclohexane (mixture if isomers)

Method

Type of population:
occupational
Subjects:
- Number of study subjects: in 18 centers a total of 92 patients
- Sex: 71 men and 21 women
- Age: ranged from 17 to 77 years (mean age 44.2+/-12.8; median 45 years)
Clinical history:
- Exposure history: 70 patients were tested because of suspected epoxy resin contact dermatitis
- Other: 22 patients were tested because of previously positive patch test reaction to epoxy resin from the stanard patch test series, without clear -cut history of epoxy resin system exposure
Controls:
none
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
Test I (source Geier et al., 2004)
- Vehicle / solvent: petroleum jelly
- Concentrations: 0.25%

Test II (source grey literature)
- Vehicle / solvent: petroleum jelly
- Concentrations: 0.5%

Results and discussion

Results of examinations:
Test I
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects tested with 1,2-DCH: 87
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 86
- Number of subjects with equivocal reactions: 1

Test II
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects tested with 1,2-DCH: 81
- Number of subjects with positive reactions: 2
- Number of subjects with negative reactions: 79
- Number of subjects with equivocal reactions: 0

Applicant's summary and conclusion

Conclusions:
No positive skin reactions were observed after patch testing with the submission substance at 0.25% in petroleum jelly in 87 patients with suspected contact allergy due to epoxy resin systems. In a later examination with 0.5% of the submission susbtance in petroleum jelly two out of 81 patients shwed positive test results (there are no details about clinical relevance of these findings).
Executive summary:

In this study patients with suspected contact allergy due to epoxy resin systems were patch tested with various constituents of epoxy resin systems. Patch test with the submission substance at 0.25% in petroleum jelly were performed in 87 patients. 86 patients showed no skin reaction and only person revealed a questionable test result. The study authors mention that it cannot be excluded that the tested concentration was too low and further tests should be carried out with higher test concentrations. Because of this in a later stage of the study 81 patients were tested with 0.5% DCH in petroleum jelly. Two patients were found to have positive skin reactions. Nevertheless no details on clinical relevance of these findings are given.