Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
approx. 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented with acceptable restrictions: Lacking documentation on total number of persons tested for each substance

Data source

Reference
Reference Type:
publication
Title:
Occupational skin diseases from epoxy compounds
Author:
Jolanki R
Year:
1991
Bibliographic source:
Acta Derm. Venereol. Suppl. 159, 7-80
Report date:
1991

Materials and methods

Study type:
human medical data
Remarks:
occupational contact dermatitis
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
Experiment was designed to confirm a skin sensitisation potential towards the substance trimethylhexamethylene diamine
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
EC Number:
247-063-2
EC Name:
2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
Cas Number:
25513-64-8
Molecular formula:
C9H22N2
IUPAC Name:
2,2,4-trimethylhexane-1,6-diamine; 2,4,4-trimethylhexane-1,6-diamine
Constituent 2
Reference substance name:
Trimethylhexane-1,6-diamine
EC Number:
247-134-8
EC Name:
Trimethylhexane-1,6-diamine
Test material form:
other: liquid
Details on test material:
Trimethyl hexamethylene diamine provided by Chemische Werke Hüls AG (Germany), consisting of equal parts of the 2,2,4- and 2,4,4-isomers,
purity >= 99.7 %.
Actually the test substance is identified in the reference with CAS No. 25620-58-0. However, the production process has been yielding the 2,2,4 (or 2,4,4) isomer mixture (CAS No. 25513-64-8) all the time since the beginning of the production of this substance at this site. In previous years the substance was not identified with a precision sufficient for REACH. The correct CAS No. would have been 25513-64-8 all the time.

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
- General: A total of 3713 + 18 persons examined for suspected occupational skin diseases in Helsinki + Vaasa during 1974-1990 was considered. The study was focussed on 142 persons (criteria: current + skin disease + occupational + expoxy compound caused).
- Substance specific: Patch tests with a concentration of up to 1.0 %  trimethylhexane-1,6-diamine in petrolatum were performed to confirm allergy towards this substance. Patch testing with this substance was begun in December 1989.

Results and discussion

Results:
1844 humans were diagnosed to have occupational skin diseases (other 1887: non-occupational). Among these, 142 (92 men and 50 women) were  considered to have skin disorders from current occupational exposure to epoxy compounds. Among these 142, 135 had allergic contact dermatitis, five had irritant contact dermatitis, and two had contact urticaria according to the diagnoses met. 
- Substance specific: Contact allergy to trimethylhexane-1,6-diamine was diagnosed for one person. This was a floorlayer coating concrete floors,  who had developed dermatitis after five years of work. Three out of eight components of the hardeners he had handled gave positive allergic reactions. (The other two were isophorone diamine and xylylene diamine.)  He could not continue his work. Allergic contact dermatitis caused by this substance had earlier not been reported. A test concentration of 0.1 - 0.5 % was found to be suitable for patch testing, i.e. to induce neither irritation nor active sensitization.

Any other information on results incl. tables

No further information.

Applicant's summary and conclusion

Conclusions:
In this investigation with 142 persons skin sensitization was observed at concentrations above 0.5  %  trimethylhexane-1,6-diamine in petrolatum.