2-hydroxyethyl methacrylate

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

other: human patch test data collection consecutive patients

Adequacy of study:

other information

Study period:

21 February 2005 to 30 June 2007 Malmö
1 July 2005 to 30 June 2007 Singapore

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 acrylate/methacrylate allergy in the beseline series: our experience in Sweden and Singapore

Author:

Goon A T-J et al

Year:

2008

Bibliographic source:

Contact dermatitis 2008, 59: 307-313

Materials and methods

Study type:

other: study specifically designed to determine the prevalence of contact allergy to acrylates/methacrylates in entire populations of patients patch tested in a dermatology centre

Endpoint addressed:

skin sensitisation

Principles of method if other than guideline:

The allergens were applied onto small (8 mm) Finn Chambers1 (Epitest Ltd Oy, Tuusula, Finland)
on Scanpor1 (Norgesplaster A/S, Vennesla, Norway). The tests were applied to the upper part
of the back and left for 2 D. Tests were read on D3 or D4 and D7 by a dermatologist, and the
reactions were scored according to International Contact Dermatitis Research Group criteria.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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 petrolatum

Method

Type of population:

general

occupational

Ethical approval:

not specified

Details on study design:

Study on all patients patch tested to the baseline patch test series in two dermatology centres – the
Department of Occupational and Environmental Dermatology,Malmo¨ University Hospital,Malmo¨ ,
Sweden and National Skin Centre, Singapore. Five acrylate/methacrylate allergens, obtained from
Chemotechnique Diagnostics (Vellinge, Sweden), were included in the baseline series of both
centres.
The acrylate/methacrylate allergens added to the baseline series were
2-hydroxyethyl methacrylate (2-HEMA) 2.0% petrolatum (pet.) w/w,
methyl methacrylate (MMA) 2.0% pet. w/w,
ethylene glycol dimethacrylate (EGDMA) 2% pet. w/w,
triethylene glycol diacrylate (TREGDA) 0.1% pet. w/w, and
2-hydroxypropyl acrylate (2-HPA) 0.1% pet. w/w.

The additional allergens including 2-HEMA were applied to all patients for whom the baseline series
had been ordered over virtually the same period of at least 2 years in both centres.

Results and discussion

Results:

Results of examinations
19/2790 (0.7%) of all patients tested reacted positive for HEMA.
19/38 (50%) patients tested positive for at least one acrylate/methacrylate tested positive for HEMA.
One patient who had negative readings to 2-HEMA on D3 and D7 was found to have a positive reaction to this allergen when she was seen again 1 month after the patch test application.

Any other information on results incl. tables

Overall, 38 patients in total had reacted to acrylate/ methacrylate allergens in the baseline series during the study period in both populations.

In Malmö, there were 26 (1.6%) of 1609 patients (mean age 46 years, range 23–81 years) with positive patch tests to acrylate/methacrylate allergens in the baseline series. There were 9 (1.4%) of 632 males (mean age 45 years, range 24–72 years) and 17 (1.7%) of 977 females (mean age 46 years, range 23–81 years) in this group.

Of the 26 positive reactors in Malmö, 14 (54%) had been found to have relevant (clinical) reactions to acrylate/methacrylate allergens; 6 female nail technicians, 3 female dental workers, 3 men who worked with ultraviolet-cured acrylates, and 2 female acrylic nail users.

In Singapore, there were 12 (1.0%) of 1181 patients (mean age 38 years, range 19–61 years) with positive patch tests to acrylate/methacrylate allergens in the baseline series. There were 5 (0.9%) of 547 males (mean age 38 years, range 19–56 years) and 7 (1.1%) of 634 females (mean age 38 years,range 23–61 years) in this group.

Applicant's summary and conclusion

Executive summary:

Five acrylate/methacrylate allergens (2-hydroxyethyl methacrylate, methyl methacrylate, ethylene glycol dimethacrylate, triethylene glycol diacrylate, and 2-hydroxypropyl acrylate) were included in the baseline series for at least 2 years in Malmö and Singapore to determine the prevalence of acrylate/methacrylate allergy in all patients tested to the baseline patch test series.

 

38/2790 (1.36%) patients in total had reacted to acrylate/methacrylate allergens in the baseline series

during the study period in both populations.

19/38 (50%) patients tested positive for at least one acrylate/methacrylate tested positive for HEMA.

19/2790 (0.7%) of all patients tested reacted positive for HEMA.