Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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

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.