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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Contact allergy to allyl glycidyl ether present as an impurity in 3-glycidyloxypropyltrimethoxysilane, a fixing additive in silicone and polyurethane resins.
Author:
Dooms-Goossens A, Bruze M, Buysse L, Fregert S, Gruvberger B and Stals H.
Year:
1995
Bibliographic source:
Contact dermatitis 33: 17-19

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
A patch test was performed on a 43-year-old man who worked in the plastic industry and suffered from an occupational dermatitis on the hands and forearms.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Allyl Glycidyl Ether

Method

Type of population:
occupational
Subjects:
- Number of subjects exposed: 1
- Sex: male
- Age: 43 years
Clinical history:
- History of allergy or casuistics for study subject or populations: a 43-year-old man working in the plastic industry was reported to suffer from an occupational dermatitis (weeping eczema) on the hands and forearms after being in contact with an epoxy silane compound (3-glycidyloxypropyltrimethoxysilane) that was contaminated with (5% v/v) allyl glycidyl ether. Local corticosteroid therapy with an ointment and a cream containing betamethasone dipropionate kept the dermatitis only partly under control. He had not previously had any skin problems, and the history of atopy was negative.After transfer to another job in the same company, the patient's dermatitis cleared.
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Vehicle / solvent: acetone or olive oil
- Concentrations: 0.005, 0.05, 0.1 and 0.5% of Allyl Glycidyl Ether (AGE)
- In addition, he was tested with 3-glycidyloxypropyltrimethoxysilane (contaminated with 5% v/v AGE)

EXAMINATIONS
- Other: HPLC analysis of the contaminants was performed

Results and discussion

Results of examinations:
RESULT OF CASE REPORT: AGE in acetone and in olive oil was found to be positive at a concentration of 0.05% and above in both vehicles. In addition, contaminated 3-glycidyloxypropyltrimethoxysilane yielded positive reactions down to a concentration of 1%.

Any other information on results incl. tables

Results of skin testing

Substance

2nd day

3rd day

Allyl Glycidyl Ether in acetone

0.5%, 0.1%, 0.05%

+

+

0.005%

-

-

Allyl Glycidyl Ether in olive oil

0.5%, 0.1%, 0.05%

+

+

0.005%

-

-

Applicant's summary and conclusion