Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Sensitization to patch test acrylates.
Author:
Kanerva L, Estlander T, Jolanki R, Tarvainen K
Year:
1993
Bibliographic source:
Contact Dermatitis 28: 268-275

Materials and methods

Type of sensitisation studied:
skin
Study type:
survey
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
During 1982-1985 a project dealing with hand dermatitis in dental technicians was started using a skin sensitization tester set of 7 different acrylates.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Purity unknown

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 22
Clinical history:
Contact dermatitis
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: The Finn-chamber method with an occlusion time of 24 h was used. The tests were applied on the back with a non-occlusive porous tape (Scanpor® Surgical Tape, Norgeplaster A/S, Norway); or when the back was full of patch tests, the thighs were used.
- Vehicle / solvent: petrolatum
- Concentrations: 1 %
- Testing/scoring schedule: The tests were read on removal and 24 h, 48 h, and 96-120 h after removal (at least 3 readings).


Results and discussion

Results of examinations:
During 1982-1985, 1 out of 22 patients with contact dermatitis tested with 7 different acrylates showed a positive patch test reaction to tert-butyl acrylate (1 % in petrolatum) and one showed slight to moderate irritation at 24 h.

Applicant's summary and conclusion