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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:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A patch test with a series of 28 (meth-)acrylates was used to test patients for allergic contact dermatitis caused by these substances. 1,6-Hexanedioldiacrylate (HDDA) was one out of the 28 substances tested. However, no detailed data for HDDA were reported and previous exposure to HDDA is highly unlikely at least for the 4 dermatitis cases described.

Data source

Reference
Reference Type:
publication
Title:
Sensitization to patch test acrylates
Author:
Kanerva L, Estlander T, Jolanki R
Year:
1988
Bibliographic source:
Contact Dermatitis 18: 10-15

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
Patients with contact dermatitis were tested for sensitization of 28 commercial (meth-)acrylates using the Finn-chamber method (Contact dermatitis 1: 48-52, 1975) with an occlusion time of 24 hours. After removal of the test substance at least 3 readings were made.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexamethylene diacrylate
EC Number:
235-921-9
EC Name:
Hexamethylene diacrylate
Cas Number:
13048-33-4
Molecular formula:
C12H18O4
IUPAC Name:
hexane-1,6-diyl bisacrylate
Details on test material:
- Name of test material (as cited in study report): 1,6-hexanediol diacrylate
- Analytical purity: no data given

Method

Type of population:
occupational
Controls:
no controls
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn chamber
- Vehicle / solvent: petrolatum
- Concentrations: 0.1 % (w/w); 0.0044 M
- Testing/scoring schedule: exposure of the test material for 24 h under occlusive conditions, removal of the test substance, readings after removal and 24 h, 48 h, and 96-120 h after removal (at least 3 readings) by a dermatologist.

Results and discussion

Results of examinations:
12 of 24 patients showed no reaction to the (meth-)acrylate series. 3 were found to have a relevant allergic reaction and were diagnosed as having an occupational allergic contact dermatitis to acrylates. 9 patients showed a slight irritation at the 24 h and 48 h readings, sometimes also at 72-96 h, three of these were sensitized. No detailled information was given regarding reactions to HDDA.

Applicant's summary and conclusion