Registration Dossier
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EC number: 212-782-2 | CAS number: 868-77-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Document sufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Occupational exposure in dentistry and miscarriage
- Author:
- Lindbohm, M-L, Ylostalo, P., Sallmen, M. et al
- Year:
- 2 007
- 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
- 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 2-methylprop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): HEMA
Constituent 1
Method
- 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:
- measured
- 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
- Results:
- 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
- Conclusions:
- 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.
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