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Diss Factsheets
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EC number: 931-597-4 | CAS number: -
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP compliant, non-guideline experimental investigation. Study published in scientific, peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies of the chronic inhalation of coal fly ash by rats.
- Author:
- Raabe O G, Tyler W S, Last J A, et al.
- Year:
- 1 982
- Bibliographic source:
- Ann Occup Hyg. 26(1-4):189-211.
Materials and methods
- Principles of method if other than guideline:
- Rats were exposed to respirable (mass median aerodynamic diameter MMAD about 2 μm) aerosols of size-classified power plant fly ash at average concentrations of up to 4.2 mg m(3) for 8 h per day for up to 180 consecutive days. The aerosols were characterized with respect to both physical and chemical properties. Sampling time points were after exposure for 7, 50, 90 or 180 days. Immediately after exposure, the animals were evaluated biochemically, morphologically and with other sensitive biological tests to detect effects associated with fly ash inhalation when compared with unexposed controls.
- GLP compliance:
- no
Test material
- Reference substance name:
- Coal fly ash
- EC Number:
- 924-417-0
- IUPAC Name:
- Coal fly ash
- Details on test material:
- Fly ash was obtained from the electrostatic precipitator hoppers of a power plant burning western USA low-sulphur, high-ash coal, and size classified to remove most particles larger than 3 um in aerodynamic diameter. The resulting fly ash source material had a volume median diameter of 1.77 um (SE 0.06) and geometric standard deviation of 1.52 (SE 0.04).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- The rats were 70 days old Hilltop chronic respiratory disease (CRD) –free male rats, During exposure the rats were maintained in pairs in stainless steel wire mesh cages. Conditions in exposure chambers: temperature 21 ± 2 ºC, relative humidity 50 ± 20%.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: 1.77 / 1.52
- Details on inhalation exposure:
- see Fig. 1
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Royco 225 light-scattering particle counter (Royco Instruments, Menlo Park, CA, USA). Comparison measurements were made using a Climet 208 light-scatter particle counter (Climet Instruments, Redlands, CA, USA). Particle size distribution data were collected with these instruments operated in conjunction with a multichannel pulse height analyzer.
see attached Figure - Duration of treatment / exposure:
- Two series of experiments were carried out with the sampling time points after 7, 50 or 90 days of exposure and after 90 or 180 days of exposure, respectively.
- Frequency of treatment:
- Daily 8 h/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4.2 mg/m3
Basis:
- No. of animals per sex per dose:
- 9 - 32
- Control animals:
- yes
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- Body weight in the beginning and at the end of exposure.
- Sacrifice and pathology:
- Morphological evaluation of lungs: Lung volume, histopathology (light microscopy, HE staining), scanning electron microscopy (SEM), analytical electron microscopy, back-scattered electron (BSE) image for identification of individual fly ash particles.
Biochemical evaluation of lungs: DNA, RNA, protein and hydroxyproline content, mucus glycoprotein synthesis and secretion rates.
Cellular studies on lungs: alveolar macrophage and haematopoietic progenitor cell kinetics, macrophage functional assays (mobility, phagocytic indices), bone marrow granulocyte-monocyte progenitors. - Other examinations:
- Lung burden measurements (aluminum) and calculation of deposited fraction in lungs.
- Statistics:
- Student’s t test, Mann-Whitney rank-sum test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No mortality or clinical signs reported
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality or clinical signs reported
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No effect on lung weight, no data for other organs
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Histopathology: non-neoplastic
CFA exposed animals had higher concentration of alveolar macrophages in alveolar lumens and refractile brownish pigment (presumably fly ash) was visible in these cells. Alveolar macrophages were larger than in lungs of control animals. Alveolar septal walls contained occasionally cellular aggregates consisting of some mononuclear leucocytes admixed with brownish particulate material (ash). These differences between CFA exposed and control animals had minimal impact, if any, on health status of the animals.
Lung burdens of up to 4 mg of ash were found, macrophages lavaged from lungs of exposed rats were more numerous and yielded more progenitor cell colonies in culture than from controls, tracheal mucous glycoprotein secretion was decreased at 7, 50 and 90 days of exposure and increased at 180 days and clumping of fly ash in cells in the lungs was observed. Despite of this, there were no apparent untoward health effects from inhaled fly ash, since the observed differences between exposed and control rats did not constitute an adverse response.
Effect levels
- Remarks on result:
- not measured/tested
- Remarks:
- Measured parameters defined in method description
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Lung burdens of up to 4 mg of ash were found. Macrophages lavaged from lungs of exposed rats were more numerous and yielded more progenitor cell colonies in culture (at the 10% confidence level based on the Mann-Whitney rank-sum test) than from controls. Tracheal mucous glycoprotein secretion was decreased at 7, 50 and 90 days of exposure and increased at 180 days. Clumping of fly ash in cells in the lungs was observed. There were no apparent untoward health effects from inhaled fly ash, since the observed differences between exposed and control rats did not constitute an adverse response.
Applicant's summary and conclusion
- Conclusions:
- There were no apparent untoward health effects from inhaled fly ash, since the observed differences between exposed and control rats did not constitute an adverse response.
- Executive summary:
Respiratory disease-free rats were exposed in two experiments to respirable (mass median aerodynamic diameter MMAD about 2 μm) aerosols of size-classified power plant fly ash at average concentrations of up to 4.2 mg m(3) for 8 h per day for up to 180 consecutive days. The aerosols were characterized with respect to both physical and chemical properties. Immediately after exposure, the animals were evaluated biochemically, morphologically and with other sensitive biological tests to detect effects associated with fly ash inhalation when compared with unexposed controls. Lung burdens of up to 4 mg of ash were found. Macrophages lavaged from lungs of exposed rats were more numerous and yielded more progenitor cell colonies in culture (at the 10% confidence level based on the Mann-Whitney rank-sum test) than from controls. Tracheal mucous glycoprotein secretion was decreased at 7, 50 and 90 days of exposure and increased at 180 days. Clumping of fly ash in cells in the lungs was observed. There were no apparent untoward health effects from inhaled fly ash, since the observed differences between exposed and control rats did not constitute an adverse response.
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