Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
other information
Study period:
January 1987 - April 1992 (guerra et al.); January 1984 - May 1992 (Tosti et al.)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Prevalence and sources of occupational contact sensitization to acrylates in Italy.
Author:
Guerra L et al.
Year:
1993
Bibliographic source:
Contact Dermatitis 28: 101-103
Reference Type:
publication
Title:
Occupational Skin Hazards from Synthetic Plastics.
Author:
Tosti A et al.
Year:
1993
Bibliographic source:
Toxicol. Ind. Health 9: 493-502

Materials and methods

Type of study / information:
Type of experience: Human
Endpoint addressed:
skin sensitisation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
82 patients suspected of occupational acrylic sensitization were patch tested with the GIRDCA standard series (Hermal-Trolab, Bracco-Milan) and an extensive acrylate series, supplied by Firma S.p.A . (Florence)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): isobutyl acrylate

Method

Ethical approval:
not specified
Details on study design:
Patients were patch-tested with 5 % of isobutyl acrylate dissolved in petrolatum.

Results and discussion

Any other information on results incl. tables

Guerra et al: 
Between January 1987 and April 1992, 82 patients suspected of occupational acrylic sensitization were patch tested with
standard series and an extensive acrylate series, including isobutyl acrylate (5 % in petrolatum). No positive patch
test reaction to isobutyl acrylate was reported in this group of patients. Detailed results for all acrylates used were not provided.
Tosti et al.:

January 1984 to May 1992, 39 cases of occupational allergic contact dermatitis to epoxy resin system substances were detected. An allergic airborne contact dermatitis was present in 25 patients. Thirty patients showed positive patch test reaction resin, whereas 9 patients showed isolated sensitizations to reactive diluents and/or hardeners.

Eighteen of the 39 patients affected by occupational contact dermatitis due to epoxy resins were employed in the electronics industry. Ten of these 16 patients worked in the same electromechanical factory producing condensers for radio and television sets.Three workers were involved in the manufacture of fiberglass fishing-rods and developed an airborne contact dermatitis due to textile fibre dusts. No positive patch test reaction to isobutyl acrylate was reported in this manuscript. Detailed results of the investigated patch tests were not provided.

Applicant's summary and conclusion