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Exposure related observations in humans: other data

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exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
other information
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Document sufficient for assessment

Data source

Reference Type:
Occupational exposure in dentistry and miscarriage
Lindbohm, M-L, Ylostalo, P., Sallmen, M. et al
Bibliographic source:
Occupational Environ. Med. 64: 127-133

Materials and methods

Type of study / information:
Information on the reproductive effects of chemical exposures in dental work
Endpoint addressed:
toxicity to reproduction / fertility
Principles of method if other than guideline:
The study was conducted among women dental workers and a comparison group of workers occupationally unexposed to dental restorative materials. Information on pregnancies was obtained from national registers and outpatient units of hospitals. Data on occupational exposure were obtained using postal questionnaires. The final study population included 222 cases of miscarriage and 498 controls (births). An occupational hygienist assessed exposure to acrylate compounds, disinfectants and solvents. Exposure to other agents was assessed on the basis of the questionnaire data. Odds ratios (ORs) and confidence intervals (CIs) were estimated using conditional logistic regression.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxyethyl methacrylate
EC Number:
EC Name:
2-hydroxyethyl methacrylate
Cas Number:
Molecular formula:
2-hydroxyethyl methacrylate
Details on test material:
- Name of test material (as cited in study report): HEMA


Ethical approval:
confirmed, but no further information available
Details on study design:
The source population of the study was composed of women belonging to the national trade unions of dentists, dental nurses and hygienists, dental technicians and dental laboratory workers, as well as pharmacists, secretaries and receptionists in health care. The pharmacists, secretaries and receptionists in health care represented women working in the health care sector but occupationally unexposed to acrylate compounds and mercury. The trade unions were asked to provide information on women who were born in 1951 or later, and who had belonged to the union during 1992–9.
Exposure assessment:
Details on exposure:
Exposure to HEMA was assessed by the frequency of restoration cementation, and replacement of composite resin restorations or glass ionomer restorations (if a product including HEMA was used).

Results and discussion

The ORs adjusted for confounding factors were increased for moderate-exposure and high-exposure categories of mercury amalgam (OR 2.0, 95% CI 1.0 to 4.1 andOR 1.3, 95% CI 0.6 to 2.5, respectively). The risk was slightly increased for the highest-exposure category of 2-hydroxyethylmethacrylate (OR 1.4, 95% CI 0.7 to 2.6).

Applicant's summary and conclusion

No strong association or consistent dose–response relationship was observed between exposure to chemical agents in dental work and the risk of miscarriage. A slightly increased risk was found for exposure to mercury amalgam, some acrylate compounds, solvents and disinfectants. These findings indicate that the possibility of a weak association between exposure to these agents and an increased risk of miscarriage cannot be excluded.