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Diss Factsheets
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EC number: 231-545-4 | CAS number: 7631-86-9
- 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
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
- Study type:
- cross sectional study
- Endpoint addressed:
- respiratory irritation
- respiratory sensitisation
- repeated dose toxicity: inhalation
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
Constituent 1
- Specific details on test material used for the study:
- SAS from five german production plants
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Exposure assessment:
- estimated
- Details on exposure:
- We like to emphasize that the average duration of exposure was 12.4 years in this study with a maximum of 42 years (Table 5 in the study by Morfeld et al). Although a cumulative exposure of 80 mg/m3-years is within the range of observed exposures (the 95th percentile is at 144 mg/m3-years, Table 7 in the study by Morfeld et al), an evaluation at 40 years (maximum working life time) means an extrapolation.
- Statistical methods:
- We used multiple linear and logistic regression models and Monte Carlo multimodel analyses of two exposure scenarios to evaluate the effect of cumulative exposure to inhalable SAS dust on symptoms, spirometry, and chest films in 462 male workers from five German SAS-producing plants.
Results and discussion
- Results:
- Exposure to SAS was associated with a reduction in forced vital capacity (FVC) in one of the two exposure scenarios but had no effect on forced expiratory volume in 1 second (FEV1) or FEV1/FVC in either exposure scenario. Monte Carlo analysis indicated a decline in FVC of -11mL per 10 mg/m3-years exposure (-6 to -0.4). Chest films showed no evidence of pneumoconiosis.
- Confounding factors:
- Smoking, Chronic Bronchitis, Atopy assessment by prick test, Atopy assessment by spec. IgE, Medication, Prior exposure to fibrogenic dust, Prior exposure to substances
- Strengths and weaknesses:
- The weakness of this study is its cross-sectional design with possible underestimation of the effects due to a healthy worker survivor effect (HWSE).
One of the strengths of this study is the high participation rate (96% of the active workforce), which will eliminate a potential selection bias by exposure circumstances.
Another strength is the multiple exposure assessment, partially based on a large number of personal inhalable dust exposure measurements.
Applicant's summary and conclusion
- Conclusions:
- Chest films showed no evidence of pneumoconiosis.
(This study provides limited evidence of minor dose-related effects of chronic exposure to SAS on lung function.) - Executive summary:
Objectives: The aim of this study was to assess the health impact of chronic exposure to synthetic amorphous silica (SAS) on nonmalignant respiratory morbidity. Methods: We used multiple linear and logistic regression models and Monte Carlo multimodel analyses of two exposure scenarios to evaluate the effect of cumulative exposure to inhalable SAS dust on symptoms, spirometry, and chest films in 462 male workers from five German SASproducing plants. Results: Exposure to SAS was associated with a reduction in forced vital capacity (FVC) in one of the two exposure scenarios but had no effect on forced expiratory volume in 1 second (FEV1) or FEV1/FVC in either exposure scenario. Monte Carlo analysis indicated a decline in FVC of -11mL per 10 mg/m3-years exposure (-6 to -0.4). Chest films showed no evidence of pneumoconiosis. Conclusion: This study provides limited evidence of minor dose-related effects of chronic exposure to SAS on lung
function.
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