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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:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Method not validated

Data source

Reference
Reference Type:
publication
Title:
Occupational contact sensitization to 1,2-diaminocyclohexane
Author:
Kirkup, M.E.; Murphy, J.; Beck, M.H.; Sansom, J.E.
Year:
2001
Bibliographic source:
Contact Dermatitis, 45, 121-122

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
Patch test on with four individuals with suspected sensitisation towards the submission substance.
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

Method

Type of population:
occupational
Subjects:
Case 1: 48 year old male, laboratory technician, working with epoxy resins, amine hardeners and phenol-formaldehyde resins, presented itchy vesicular eczema primarily on the hands
Case 2: 54 year old male, paint sprayer, acute eczema on face and neck on return to work after holidays, worsening over 24 hours; milder eczema of the legs a few months earlier
Case 3: 46 year old male, paint sprayer, milder eczema of the lower legs, 5-month history of itchy eczema on the shins
Case 4: 53 year old male, paint sprayer, 8-month history of blistering and fissurin of the skin of his fingers itchy eczema on the shins
Case 1,2, and 3 all worked at the same aerospace paintshop. Case 4 worked at another aircraft manufacturer.
Controls:
Some control subjects were included.
(Case report 1: control sincluded no number given; Case report 2 and 3: 8 control subjects; Case report 4: no controls reported)
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

Results and discussion

Results of examinations:
RESULT OF CASE REPORT:
Case 1: positive reactions noted to 1,2-diaminocyclohexane at 0.2% and 1% pet. Control tests with 1,2-diaminocyclohexane at 0.2% were negative.
Case 2 and 3: positive reactions noted to the paint hardener at 1% pet; positive reactions noted to EURODUR at 1% pet, individual constituents of this component (D2 and D4 m-xylenediamine and ED47/PFA (a derivative of 1,2-diaminocyclohexane) gave positive results. At 0.02% +, 0.1% ++ and 1% pet. +++. 8 controls did not react to this latter compound.
Case 4: positive reactions noted to D2 and D4 m-xylenediamine and ED47/PFA (a derivative of 1,2-diaminocyclohexane) at 0.1% pet

Applicant's summary and conclusion

Conclusions:
No clear conclusion from this study can be drawn.
Executive summary:

4 cases with eczema after occupational exposure to epoxy resin systems were reported. Patch testing with several constituents of the used epoxy resin systems were performed. Only in one case positive reactions were found for the submission susbtance (0.1% and 0.2). In the three other cases positive reactions were found for a derivate only.