Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All key data reported in study

Data source

Reference
Reference Type:
publication
Title:
Delayed and immediate hypersensitivity to Carbitols
Author:
Dawson TAJ, Black RJ, Strang WC, Millership JS, Davies I
Year:
1989
Bibliographic source:
Contact Dermatitis, 21, 52

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline required
GLP compliance:
no
Remarks:
not appropriate

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As the solvent in inks used by case report but also in the pure form.

Method

Type of population:
occupational
Ethical approval:
not applicable
Subjects:
- Number of subjects exposed: 1
- Sex: male
- Age: 60
Clinical history:
no data
Controls:
For final test procedure: water used as a control and 6 control subjects.
Route of administration:
dermal
Details on study design:
For follow up studies

TYPE OF TEST(S) USED: patch test (epicutaneous test) using European standard series. No further data

Final test procedure carried out after 1 year:

ADMINISTRATION
- Type of application: open
- Description of patch: none
- Vehicle / solvent: none
- Concentrations: 100%
- Volume applied: 0.1ml
- Testing/scoring schedule: tests carried out weekly and scored after 1 hour of exposure
- Removal of test substance: no

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: Acute diffuse erythematous dermatitis mainly on the dorsa of hands and forearms, but also on the face and neck.

RESULT OF CASE REPORT: Patch testing showed clear positive response to 2-(2-butoxyethoxy)ethyl acetate (DEGBEA). The patient then avoided contact with the substance and the symptoms subsided. After a few months, the patch testing was repeated using DEGBEA in methyl ethyl ketone solvent. Solutons of 25% or more gave positive results at 48 and 72 hours whilst those of 10% or less were negative. After 1 year (no exposure), the patch testing was repeated and no positive results were seen with up to 50% solutions in MEK (maximum tested).

Final test procedure (after patch tests negative). Within 20 minutes of exposure to pure material applied as a drop, erythema and urticaria developed at the site, which persisted for several days. No effect was seen with water (control) and no response to the test substance in the control subjects.

Any other information on results incl. tables

The response with an apparent reversal of sensitivity is unusual. The authors of the study could not explain the fading intensity of response with time after daily exposure to the substance ceased.

Applicant's summary and conclusion

Conclusions:
A case report indicates that 2-(2-butoxyethoxy)ethyl acetate can induce delayed and immediate hypersensitivity in isolated human cases.