Cyclohex-1,2-ylenediamine

Sensitisation data (human)

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 four individuals with suspected sensitisation towards the submission substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohex-1,2-ylenediamine

EC Number:

211-776-7

EC Name:

Cyclohex-1,2-ylenediamine

Cas Number:

694-83-7

Molecular formula:

C6H14N2

IUPAC Name:

cyclohexane-1,2-diamine

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 fissuring of the skin of his fingers itchy eczema on the shins
Case 1,2, and 3 all worked at the same aerospace paint shop. 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 substance (0.1% and 0.2). In the three other cases positive reactions were found for a derivate only.