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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Title:
Sensitivity to methyl methacrylate
Author:
Nyquist G.
Year:
1958
Bibliographic source:
Trans. Royal School Dent. 1: 36-51 (1958)

Materials and methods

Type of study / information:
Study with volunteers to assess the potential for skin irritation and skin sensitisation in humans.
Endpoint addressed:
skin irritation / corrosion
skin sensitisation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study with volunteers to assess the potential for skin irritation and skin sensitisation in humans via a modified patch test.
GLP compliance:
no

Test material

Reference
Name:
Unnamed

Method

Ethical approval:
confirmed, but no further information available
Details on study design:
Twenty female volunteers without reported previous contact to MMA were patch tested with 5% MMA in liquid paraffin or olive oil (purity, stabiliser content not indicated) continuously for 48 h.
Exposure assessment:
not specified

Results and discussion

Results:
Eighteen of 20 volunteers responded with skin reactions varying from erythema to delayed eczematous dermatitis. A distinct differentiation between sensitisation and irritation reactions was not made by the author.  In a follow-up patch test of the same subjects with small plates of heat cured acrylic resin containing 5.2% to 6.4% of residual MMA monomer no skin reactions were observed.

Applicant's summary and conclusion

Conclusions:
Eighteen of 20 volunteers responded with skin reactions varying from erythema to delayed eczematous dermatitis. A distinct differentiation between sensitisation and irritation reactions was not made by the author. In a follow-up patch test of the same subjects with small plates of heat cured acrylic resin containing 5.2% to 6.4% of residual MMA monomer no skin reactions were observed.
Although a clear distinction between sensitisation and irritation is difficult and the exposure period is far longer than usual in irritation testing the results suggest that MMA may have the potential for skin irritation in humans.
Executive summary:

Eighteen of 20 volunteers responded with skin reactions varying from erythema to delayed eczematous dermatitis. A distinct differentiation between sensitisation and irritation reactions was not made by the author. In a follow-up patch test of the same subjects with small plates of heat cured acrylic resin containing 5.2% to 6.4% of residual MMA monomer no skin reactions were observed.

Although a clear distinction between sensitisation and irritation is difficult and the exposure period is far longer than usual in irritation testing the results suggest that MMA may have the potential for skin irritation in humans.