Dibutyl maleate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Information insufficient but reliable enough to be considered for this assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Materials and methods

Type of sensitisation studied:

skin

Study type:

case report

Principles of method if other than guideline:

Patch tested with ICDRG standard series of allegerns and with the test material.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl maleate

EC Number:

203-328-4

EC Name:

Dibutyl maleate

Cas Number:

105-76-0

Molecular formula:

C12H20O4

IUPAC Name:

dibutyl but-2-enedioate

Details on test material:

The glues in question included PVA No III, urea and dibutyl maleinate. Glues contained dextrin, triacetin, sodium benzoate, propylene glycol, butylcarbitol acetate and antifoaming agents.

Method

Type of population:

occupational

Ethical approval:

not specified

Subjects:

11 employees

Clinical history:

no data

Details on study design:

A worker had skin complaints and other 11 employees also developed contact dermitis during 1 1/2 years. As a result of the outbreak, standard patch tests (Trolab) were conducted. All 11 employees had the standard patch test series and supplementary patch tests were applied. The test with 10% dibutyl maleinate in acetone was applied to 20 individuals (control) with eczematous disorders. 50% of the workers were exposed to the PVA glue containing dibutyl maleinate. The patch concentrations were established based on Malten & Zeilhuis (Industrial toxicology and dermatology in the production and processing of plastic. Amsterdam: Elsevier Publishing Company, 1964:66, 81). The concentration of dibutyl maleate was used in the patch test was 10% in acetone.

Results and discussion

Results of examinations:

Skin lesions observed among the employees included red, scaldy or vesicular dermititis involving the fingers, hands and in some cases the forearms. Most workers were able to continue working but cases varied in severity. Results from the patch tests on workers exposed to the PVA glue containing dibutyl maleinate exhibited an allergic reaction. The mean latency time to develop the contact allergy was 9 months.

Applicant's summary and conclusion

Conclusions:

Dibutyl maleate was considered a skin sensitizer.

Executive summary:

In an enveloped-making factory, 50% of the employees who were packing envelops and looking after envelope machines developed contact dermitits. At that time, workers were exposed to three types of glues: PVA No III, urea and dibutyl maleinate. A test patch series was conducted with 11 workers. Glue containing dibutyl maleinate or 10% of dibutyl maleinate diluted in acetone was applied and 10 of 11 workers showed positive response in the patch tests. Another test was performed with 10% of dibutyl maleinate in acetone applied to 20 controls with eczematous disorders. Controls were negative. Workers were removed from the envelop-making process and 3 month later, employees were free of dermatitis. Authors indicated that dibutyl maleate was a skin sensitizer.