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EC number: 935-756-9 | CAS number: 1344-95-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1976 and 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed according to an observational design (no randomisation). In the cross sectional study an individual dose assessment was performed and adjusted for smoking habits. Furthermore, age, length and smoking habbit adjusted control group was included. In the follow up study, no information was reported on the calibration of the lungfunction equipment between 1976 and 1982, and no control group was included.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Study type:
- cross sectional study
- Endpoint addressed:
- repeated dose toxicity: inhalation
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Standard epidemiological methodology for cross sectional studies For example : Kleinbaum and Kupper 1982 Epidemiological Research
- Deviations:
- not applicable
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- wollastonite
- IUPAC Name:
- wollastonite
- Reference substance name:
- Wollastonite (Ca(SiO3))
- EC Number:
- 237-772-5
- EC Name:
- Wollastonite (Ca(SiO3))
- Cas Number:
- 13983-17-0
- IUPAC Name:
- calcium oxosilanediolate
- Details on test material:
- Wollastonite containing
- Less than 2% free silica.
- Fibrious particulates with median diameter of d=0,22 um and median length of l=2,5 um.
Note: Hazardous fibres are defined as shapes with d<3 um and l>5 um.
Constituent 1
Constituent 2
Method
- Type of population:
- occupational
- Ethical approval:
- not applicable
- Remarks:
- observational study
- Details on study design:
- The cross sectional study was performed in 1982 among white male workers. Exact dates (or seasonal data) of the medical examination are not given. 86 Male workers from a neary electronic component plant with a comparible age, height, smoking patern, were examined as a comparison group.
The longitudinal, follow up study enrolled employees that were examined in 1982 and also earlier in 1976. Exact dates of medical data collection are not given. Two consecutive measurements per worker with a 6 years interval were compared. No control group was used. The changes per person seem to be modeled in the same way as in the cross sectional study - Exposure assessment:
- measured
- Details on exposure:
- Real time exposure measurements were performed by company, NIOSH MSHA between 1977-1981.
Mean total dust 8 hours exposure of 5 job categories:
- mining exept crushing 0,9 mg/m2
- administrative 2,3 mg/m3 (2 measurements only)
- milling & crushing 4,1 mg/m3
- labourer & beneficiator 8,71 mg/m3
- Mill maintenance and packers 10 mg/m3
Workers cummulative exposure (dose) is calculated by multiplying the exposure duration in years with the average estimated exposure based on the measurments per job and subsequently by summing the doses per function in his working life. - Statistical methods:
- cross sectional: (1) multiple linear regression of lungfunction (independant variable) with lenght, age, smoking and dust years (dependant variables)
(2) Student-t test for comparison of unpaired and unstratified means of exposued and controls
Longitudinal:multiple linear regression of lungfunction changes (independant variable) with lenght, age, smoking and dust years (dependant variables).
Results and discussion
- Results:
- In the cross sectional study of the Wollastonite exposed workers, the height independant FEV1/FVC was significant associated with the amount of dust years in mg/m3/year.Normal FEV1/FVC values normaly decrease with age with about 0,2% per year from 83% (20 years) to 75% (60 years).
For the total employee population (n=108) 1 mg/m3 total dust is assiciated with an additional decrease of 0,05 %/year.
The Peak flow decrease with age (about 0,03 l/s/year) increases with an additional 0,0088 L/sec/year (total population) and 0,0052 L/sec/year (non-smoker) per mg/m3.
In the cross sectional comparison with the controls, the Wollastonite workers showed about 8% lower FEV1/FVC and Peak-flow values.
For non-smokers only, the decrease is 0,22% per mg/m3/year. However the small number (n=32 ) makes this value less reliable - Confounding factors:
- Wollastonite workers do not differ much from the controls in age, smoking, participation rate and respiratory symptoms.
Within the Wollastonite workers age and respiratory symptoms did not differ for the different exposure categories - Strengths and weaknesses:
- Weakness:
No infront hypothesis is tested.
The FEV1/FVC ratio has normally a much higher random variance than numerator FEV1 and denominator FVC and is therefore a weaker measure to find influence of exposure than the individual FEV1 and FVC.
Follow up study
The larger decline of the FEV1 and FVC compared to literature suggest a possible influence of equipment calibration between 1982 and 1976. No information is provided on the calibration of the lungfunction equipment between 1976 and 1982 . The exposure related differences in the peak flow in the follow up study may be caused by equipment differences
In the multiple linear regression, the same dependant variables (age, length, smoking and dust years, probably status 1982) were used as in the 1982 cross sectional analysis. Since lenght and age are considered to be linear related with the lung function outcome in the multiple linear regression, these parameters should not have been included. Aging in the follow up period is for all participants about 6 years. The individual changes in lungfunction between 1976 and 1982 should have been related only to the cummulative exposure and smoking habits in the follow up period, not to the total cummulative dose.
Strenght:
The association between dust exposure and additional decrease in FEV1/FVC and Peak flow is found in two more or less independent ways:
- in the cross sectional multiple linear regression
- in the cross sectional comparison with the control group
The follow up study cannot be considered as a strength, due to the possible equipment calibration bias.
Applicant's summary and conclusion
- Conclusions:
- In line with the authors the applicant concludes that Wollastonite may not be entirely innocuous and that long term high exposure (>30 mg-year/m3) may give slight systemic effects.
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