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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see remarks
Remarks:
Acceptable publication, which meets basic scientific principles. Clear differentiation between irritant and sensitising reactions, but otherwise limitations in reporting (e.g. number of workers tested vs. affected, details on patch testing protocol, previous exposure)

Data source

Reference
Reference Type:
publication
Title:
Delayed irritation: Hexanediol diacrylate and butanediol diacrylate
Author:
Malten M, Den Arend J, Wiggers R
Year:
1979
Bibliographic source:
Contact Dermatitis, Vol 5, 178-184 (1979)

Materials and methods

Type of sensitisation studied:
skin
Study type:
survey
Principles of method if other than guideline:
Examination of industial workers.
Patch testing (no further data)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-butanediyl diacrylate
EC Number:
213-979-6
EC Name:
1,4-butanediyl diacrylate
Cas Number:
1070-70-8
Molecular formula:
C10H14O4
IUPAC Name:
1,4-butanediyl diacrylate
Details on test material:
The workers used a paint which consists of an unsaturated polyester and the crosslinking agent butanediol diacrylate.

Method

Type of population:
occupational
Subjects:
- Number of subjects exposed: 20 workers from the electron beam coating department (mainly automatic door painting process). All were observed for 4 years for skin lesions, but unclear, if patch testing was performed in all or just those developing lesions.
Controls:
none
Route of administration:
dermal
Details on study design:
Patch testing on the workers was performed with 0.01% in olive oil. BDDA had to be diluted considreably to loose its irritant properties, which were still evident at 0.02%.

Results and discussion

Results of examinations:
Detailed description of the dermatitis and the difference to the allergic contact dermatitis. Delayed contact irritacy caused by diacrylates: There may be a letancy of 12 to 24 hours before the first signs and symptoms appear. Patch testing with all constituents of paint mixture, rubber gloves and skin cleansers and medicaments used including BDDA gave negative results. Because of this and several other criteria the skin lesions were judged to be irritant rather than allergic.

Applicant's summary and conclusion