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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: human patch test data collection
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Bias-positive: patients of dermatologists or dermal clinics are a cohort preselected for having a problem with the skin, so that no valid assessment of actual prevalence can be done.

Data source

Reference
Reference Type:
publication
Title:
Screening for contact allergy to artificial nails
Author:
Constandt L, Hecke EV, Naeyaert JM, Goossens A
Year:
2005
Bibliographic source:
Contact Dermatitis 2005: 52: 7 3-77

Materials and methods

Type of sensitisation studied:
skin

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxyethyl methacrylate
EC Number:
212-782-2
EC Name:
2-hydroxyethyl methacrylate
Cas Number:
868-77-9
Molecular formula:
C6H10O3
IUPAC Name:
2-hydroxyethyl methacrylate
Specific details on test material used for the study:
2% in pet

Method

Type of population:
occupational
Ethical approval:
not applicable
Subjects:
The population tested comprised 27 patients (26 women and 1 man), all in contact with artificial nails. Of them, 16 were professional beauticians - all had contact with nail tips, gel and/or acrylic nails, glue and nail lacquer. 11 were customers - some had used only gel nails, some only acrylic nails, whereas others had used both types.
A not further specified group of them of 12 patients was tested commercial test series.
Route of administration:
dermal
Details on study design:
12 patients were tested with various substances, 9 with the complete Chemotechnique (Malmö, Sweden) printing series (24 acrylic compounds), 7 with ethyl cyanoacrylate, 5 with a small series of 5 acrylics (MMA, 2-HEMA, EGDMA, BIS-GMA and UEDMA; and 1 with 2-HEMA only.
HEMA was tested at 2% in petrolatum.

Results and discussion

Results of examinations:
In a series of patients known to be exposed to artificial nails 6/11 (> 56%) subjects patch tested with HPMA were positive.

Any other information on results incl. tables

In the same investigations 27/29 tested with HEMA were positive, 4 of 21 tested with methyl methacrylate were positive, and 2 of 13 reacted to ethyl methacrylate.

Applicant's summary and conclusion