Tetramethylene dimethacrylate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: case reports

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. Cross-reactions to other (meth)acrylates not suspended.

Data source

Reference

Reference Type:

publication

Title:

Occupational methacrylate and acrylate allergy from glues.

Author:

Aalto-Korte K, Alanko K, Kuuliala O, Jolanki R

Year:

2008

Bibliographic source:

Contact dermatitis Vol. 58, No. 6: 340-6

Materials and methods

Type of sensitisation studied:

skin

Study type:

case report

Principles of method if other than guideline:

case reports, patch test
10 patients exposed to acrylic glues with occupational contact dermatitis examined during the years 1994 - 2006, sensitivity to acrylates and methacrylates were diagnosed. The patch tests were performed with (meth)acrylate series (Chemotechnique) using the Finn Chambers (Epitest, Tuusula, Finland) according to the recommendations of the International Contact Dermatitis Research Group. The tests were read 2 or 3 times on D2-(D3)-D4/5/6 depending on the day of their application. The test vehicle was petrolatum.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Tetramethylene dimethacrylate

EC Number:

218-218-1

EC Name:

Tetramethylene dimethacrylate

Cas Number:

2082-81-7

Molecular formula:

C12H18O4

IUPAC Name:

butane-1,4-diyl bis(2-methylacrylate)

Test material form:

liquid

Method

Type of population:

other: patients with dermatitis with previous contact with (meth)acrylate (acrylic glues)

Subjects:

- Number of subjects: 10 patients with suspected contact allergy were patch tested

Route of administration:

dermal

Details on study design:

A retrospective appraisal of 473 patch test records from September 1994 to August 2006 at the Finnish Institute of Occupational Health was  made. 61 patients had allergic reactions to at least one allergen. Of these, 32 patients working in dental professions have been reported previously (Aalto-Korte k et al. (2007) Contact Dermatitis 57: 324-330). The files of 10 patients showed present occupational exposure to acrylic glues.

Results and discussion

Results of examinations:

473 patients with a history of exposure to (meth)acrylates were identified. 39 (meth)acrylates were tested in 10 to 473 of these individuals. All 10 individuals showed at least one relevant reaction. For 1,4-Butanediol dimethacrylate, 10 individuals were tested at a patch test concentration of 2% in pet.(w/w). Of these 10 (occupationally exposed and sensitised to acrylic glues) individuals, 4 showed a positive reaction to 1,4-BDDMA.

Applicant's summary and conclusion

Conclusions:

For 1,4-Butanediol dimethacrylate, 10 individuals who had contact allergy to methacrylates or acrylates and had used acrylic glues at work were tested at a patch test concentration of 2% (w/w) in petrolatum. Of these 10 individuals, 4 showed a positive reaction in respect of 1,4-BUDMA.

Executive summary:

For 1,4-Butanediol dimethacrylate, 10 individuals who had contact allergy to methacrylates or acrylates and had used acrylic glues at work were tested at a patch test concentration of 2% (w/w) in petrolatum. Of these 10 individuals, 4 showed a positive reaction in respect of 1,4-BUDMA.