2-hydroxyethyl methacrylate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: retrospective study

Adequacy of study:

supporting study

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:

Contact allergy to (meth)acrylates in the dental series in southern Sweden: simultaneous positive patch test reaction patterns and possible screening allergens

Author:

Goon, A.T.J., Isaksson, M., Zimerson, E., Goh, C.L. and Bruze, M.

Year:

2006

Bibliographic source:

Contact Dermatitis 55: 219-226

Materials and methods

Type of sensitisation studied:

skin

Study type:

case report

Principles of method if other than guideline:

10- year restrospective study of all patients patch tested to the dental patient series and dental personnel series in the Department of Occupational and Environmental Dermatology, Malmo University Hospital, Sweden- 1 January 1995 through 31 December 2004..

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

Details on test material:

- Name of test material (as cited in study report): 2-hydroxyethyl methacrylate

Method

Type of population:

other: genral and occupational

Ethical approval:

not specified

Subjects:

1632 subjects: 1322 dental patients to the dental patient series (977 females and 345 males), 81 dental personnel to the dental patient series (56 females and 25 males), and 229 dental personnel to the dental personnel series (176 females and 53 males).

Clinical history:

Dental patients and dental personnel

Route of administration:

dermal

Details on study design:

The allergens were applied onto small Finn Chambers on Scanpor. The tests were applied to the upper part of the back and left for 48 hours. Tests were read on day 3 (D3) or D4 and D7 by a dermatologist and the reactions were scored according to ICDRG criteria.

Results and discussion

Results of examinations:

Of all 1632 patients tested, 48 (37 females and 11 males) had positive results to one or more (methyl)acrylates. Positive patch tests to (meth)acrylate allergens were seen in 2.3% (30/1322) of the dental patients and 5.8% (18/310) of the dental personnel. The most common allergen for both groups was HEMA. Forty-seven out of 48 (98%) had positive patch tests to HEMA.

Applicant's summary and conclusion

Executive summary:

1632 subjects had been patch tested to either the dental patient series or dental personnel series at the department of Occupational and Environmental Dermatology, Malmo, Sweden. Positive patch tests to (meth)acrylate allergens were seen in 2.3% (30/1322) of the dental patients and 5.8% (18/310) of the dental personnel. The most common allergen for both groups was HEMA. A total of 48 people (30 patients and 18 dental personnel) reacted to methacrylates, and of these, 47 had positive patch tests to HEMA. Of the 47 responding to HEMA, 30 had simultaneous positive reactions to EGDMA. The authors concluded that if only HEMA had been used for screening, all of the sensitive individuals would have been detected. Further, reading sites only on day 3 and not day 7 would have caused 17% of those sensitive to HEMA not to have been identified. This study indicates that between 2-6% of the subjects included in the study at the clinic responded to challenge with HEMA. This prevalence, however, should not be confused with expectations for the general population however because subjects in the study were those already responding to the class of methacrylates.