Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
84 patients with contact dermatitis were patch tested with trioxane.
The purpose of the present study was to determine the relative share of irritant and allergic contact dermatitis in stomatological staff.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Trioxymethylene (trioxane), 5% in petrolatum.

Method

Type of population:
occupational
Subjects:
84 patients with contact dermatitis (38 dentists, 18 nurses and 28 dental technieans).
Clinical history:
All the patients had eruptions localised mainly on the hands, more often bilaterally, but sometimes involving the forearms and the face.
They all were questioned about the time of onset of the disease to situate it chronologically before or after the beginning of their practice. Data were collected concerning improvement during interruptions in their work. Persons with past or present atopic dermatitis or atopic mucosal symptoms (allergic, rhinitis, conjunctivitis or asthma) were regarded as atopics.
Route of administration:
dermal

Results and discussion

Results of examinations:
31 persons (36.9 %) were diagnosed as having an occupational allergie contact dermatitis (12 dentists, including 4 dental surgeons, 9 nurses and 10 dental teclmicians).
One dental nurse (1.2%) showed indications for an allergy against trioxane.

Applicant's summary and conclusion