3-aminomethyl-3,5,5-trimethylcyclohexylamine

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

approx. 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Occupational allergic contact dermatitis to isophorone diamine (IPD) used as an epoxy resin hardener

Author:

Lachapelle JM, Tennstedt D and Dumont-Fruytier M

Year:

1978

Bibliographic source:

Contact Dermatitis 4, 109-112

Report date:

1977

Materials and methods

Study type:

human medical data

Remarks:

occupational contact dermatitis

Endpoint addressed:

skin sensitisation

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-aminomethyl-3,5,5-trimethylcyclohexylamine

EC Number:

220-666-8

EC Name:

3-aminomethyl-3,5,5-trimethylcyclohexylamine

Cas Number:

2855-13-2

Molecular formula:

C10H22N2

IUPAC Name:

3-aminomethyl-3,5,5-trimethylcyclohexylamine

Details on test material:

Isophorone diamine, no further information

Method

Type of population:

occupational

Ethical approval:

not applicable

Details on study design:

3 out of 15 workers employed in the manufacture of plastic tennis rackets developed allergic contact dermatitis to isophorone diamine (IPD) and
concomitantly to epoxy resin. The tennis rackets were made of bisphenol A type with IPD as hardener without any means of protection. Symptoms
appeared 3 months, 6 weeks, or three weeks, respectively, after beginning to work in this department, and healed completely within 3 weeks after
moving to another department.
Patch tests were then performed with
- the epoxy resin (Eurepox 730) at 1 and 5 % in petrolatum,
- IPD at 1, 2 and 5 % in olive oil,
- IPD at 1, 2 and 5 % in ethanol,
- a pigment (aniline black bay-plast) at 10 % in petrolatum,
- standard series.
Investigations were conducted in 2 female and 3 male control subjects with IPD in solvents and concentrations as above (not with epoxy resin or pigment).
- Readings: at 48, 72, and 96 hours

Results and discussion

Results:

Patch tests with IPD were positive for the three sensitized persons at all concentrations and with both solvents. They were also positive for the epoxy
resin but negative for the standard series.
Patch tests were all negative for control subjects. There were no signs of irritancy. However, two of the control subjects were sensitized to IPD by
these tests, which was revealed by a typically allergic flare-up at the sites of application 7 days after the test and confirmed by further patch testing at very low concentrations.

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:

Frequent occupational exposure to Isophorone diamine may lead to the development of allergic contact dermatitis in humans.

Executive summary:

3 workers developed allergic contact dermatitis to isophorone diamine (IPD) and concomitantly to epoxy resin. Symptoms appeared 3 months, 6 weeks, or three weeks, respectively, after beginning to work in this department, and healed completely within 3 weeks after moving to another department. Patch tests with IPD (1, 2 and 5 % in olive oil or ethanol) were positive for the three sensitized persons at all concentrations and with both solvents. They were also positive for the epoxy resin (1 and 5 % in petrolatum) but negative for the standard series. Patch tests were all negative for control subjects. There were no signs of irritancy. However, two of the control subjects were sensitized to IPD by these tests, which was revealed by a typically allergic flare-up at the sites of application 7 days after the test and confirmed by further patch testing at very low concentrations.