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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Publication meets scientific standards, but other than stated in the abstract, only 23 patients (not 1619) were tested with the acrylate series. Job descriptions are only available for 9 patients with positive reactions (diagnosed with allergic dermatitis), 8 of which were dental workers for which occupational exposure is limited to methacrylates. The remaining patient did not react to 1,6 hexandiol diacrylate (HDDA), but it is unclear, if exposure occured. So the study is not considered relevant for the evaluation of the sensitizing potential of HDDA.

Data source

Reference
Reference Type:
publication
Title:
Occupational allergie contact dermatitis due to acrylates in Lodz
Author:
Marta Kiec-Swierczynska
Year:
1996
Bibliographic source:
Contact Dermatitis, 1996, 34, 419-422

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
23 dermatitis patients were patch tested to determine the source of their occupational allergies. Only results towards acrylates reported in this study.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,6-hexanediol diacryIate (HDDA)

Method

Type of population:
occupational
Subjects:
23 patients with suspected allergic dermatitis
Clinical history:
all selected patients might have had occupational contact to methacrylates or acrylates
Route of administration:
dermal
Details on study design:
The patch tests were applied to the back for 2 days. Readings were taken by the same physician on the 2nd and 3rd days. Gradings 1l+ (diffuse confluent erythema with palpable infiltration), 2+ (erythema and infiltration with papules and vesicles) and 3+ (strong erythema with papules-vesicles) were considered as a positive reaction.

Results and discussion

Results of examinations:
9 patients were diagnosed with allergic dermatitis (8 dentists / dental technician, 1 textile fabric printer). 1 dentist showed a positive reaction towards HDDA. Since their is no application for HDDA in dental products, this is most likely a cross reaction to methacrylates.

Applicant's summary and conclusion