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EC number: 930-915-9 | CAS number: 1318-02-1
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Remarks:
- in vitro bioactivity: alveolar macrophage test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: NR8383 alveolar macrophage test
- GLP compliance:
- not specified
- Remarks:
- The assay has successfully been validated against 18 short term-inhalation studies carried out under good laboratory practice (GLP) conditions.
- Type of method:
- in vitro
Test material
- Reference substance name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- EC Number:
- 930-915-9
- Cas Number:
- 1318-02-1
- Molecular formula:
- M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, y can range from 0.64 to 8.8, and w is the number of water molecules (general formula) Na: 1.34 - 24.02%, Al: 2.20 - 39.51%, Si: 15.52 - 68.64% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 6%
- IUPAC Name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Test material form:
- solid: particulate/powder
- Remarks:
- no surface treatment
Constituent 1
- Specific details on test material used for the study:
- Köstrolith, Zeocros CG180, Na Y Zeolite, SYLOSIV A4 (all provided by Grace GmbH)
Examinations
- Positive control:
- Micron-sized corundum and quartz DQ12 particles were included in the study as negative and positive particle controls, respectively
Results and discussion
Any other information on results incl. tables
Light Microscopic Observations of Particle-Treated Cells
Phase contrast images were taken from cell-free and cell-containing vials at the end of the exposure period. Untreated control cells with smooth surfaces and numerous pseudopodia occurred singly or formed small cell aggregates. In the presence of LPS (used to control for the cells competence to form TNFα) cells formed larger aggregates, which is a typical response of activated cells. Corundum and quartz DQ12 particles were added as negative and positive control materials, respectively, and reacted as expected: Corundum-treated cells were particle-laden but undamaged. Quartz DQ12 treated cells were particle laden and appeared granular and partly deteriorated.
All zeolite particles under study also formed visible precipitates at the bottom of the culture well, whose number and form were highly heterogeneous. Köstrolith, Zeocros CG180, Na Y Zeolite and SYLOSIV A4 were completely ingested by the cells, such that the bottom among cells was free of particles at the end of the treatment period, even at the highest concentration (90 μg/mL). In all these cases cells appeared largely undamaged after 16 h.
Particle Concentrations
In the next step the author looked for ultrafine particles present in the stock suspensions. Because nano-sized particles are not detectable by phase contrast microscopy and hardly settle within the incubation period, he analyzed the 16 h supernatant from the particle suspensions with the highest concentration (90 μg/mL).
All materials exhibited comparatively flat curves with multiple peaks ranging from 60 to 500 nm. Mode values as detected by the NTA software ranged from 88.1 to 252.8 nm.
Overall results indicate very low numbers of ultrafine particles in the supernatants of all zeolite suspensions, despite the high concentration of the weighed-in material (90 μg/mL).
In vitro Findings
The major aim of the study was to analyze the bioactivity of four zeolite materials using the alveolar macrophage model. Zeolites were administered to NR8383 cells under protein-free conditions at concentrations of 11.25, 22.5, 45, and 90 μg/mL. In the macrophage assay four parameters were tested: three of them, namely lactate dehydrogenase (LDH, a cytoplasmic enzyme), glucuronidase activity (GLU, a (phago)lysosomal enzyme), and tumor necrosis factor α (TNF α) were measured in the cell culture supernatant retrieved from the culture after 16 h. Because H2O2 is not stable and is released from stimulated cells for a limited period only, its concentration was measured in KRPG buffer 90 min post exposure to particles.
Controls
Untreated cell controls were included in all tests, as were particle controls which consisted of micron-sized corundum and quartz DQ12-treated cells (0-180 μg/mL), according to the standard operation procedure. While corundum elicited no adverse responses after 16 h, quartz DQ12 led to cytotoxicity, activation, and pro-inflammatory response indicated by increased release of LDH, GLU, and TNFα, respectively. TNFα responsiveness was further controlled by adding lipopolysaccharide (LPS, 0.5 μg/mL) as a specific inducer. This elicited expectedly high TNFα values (303.5±68.8 pg/mL). The induced formation of H2O2 was measurable upon both, corundum and quartz DQ12 (≤ 2.8 μM), but was expectedly high upon 360 μg/mL zymosan (16.7 ± 0.8 μM), which is a strong inducer of the NADPH oxidase reaction in macrophages. Overall, effects of cell and particle controls were within the borders of historical records, indicating the responsiveness of NR8383 macrophages and the validity of the assay.
Tested Aluminosilicates (zeolites)
Köstrolith, Zeocros CG180, Na Y Zeolite and SYLOSIV A4 elicited different responses:
SYLOSIV A4 was the least bioactive material as it was completely taken up by the cell but elicited no responses in all assays.
Köstrolith elicited cytotoxic effects indicated by increased LDH only (≥ 45 μg/mL); effects on other parameters were not observed.
Zeocros CG180 was somewhat more bioactive and moderately increased LDH, GLU, and TNFα, while H2O2 was not produced.
In contrast, Na Y Zeolite led to an increase in H2O2 formation upon 45 μg/mL, but did not influence all other parameters.
Overall, the effects of the four zeolites Köstrolith, Zeocros CG180, Na Y Zeolite, and SYLOSIV A4 on NR8383 macrophages were low or even absent and not uniform.
Applicant's summary and conclusion
- Conclusions:
- The amount of particles smaller than 200 nm, as measured with particle tracking analysis, was low or hardly measurable. The microscopically visible fractions of all materials were completely ingested by the macrophages. SYLOSIV A4 elicited no effects; Köstrolith induced a release of LDH upon 45 μg/mL (minor cytotoxic effect). Zeocros CG180 moderately increased LDH, GLU, and TNFα, indicating both, cytotoxic and pro-inflammatory effects. Na Y Zeolite increased the H2O2 formation only, a property rarely observed in the macrophage assay.
- Executive summary:
Four zeolites, namely Köstrolith, Zeocros CG180, Na Y Zeolite and SYLOSIV A4 were tested for their in vitro bioactivity with the well establish NR8383 alveolar macrophage test. Materials were dispersed in H2O with an ultrasonic dispersion energy of 270 J/mL or 1440 J/mL and administered to the cells under protein-free conditions. The cell culture supernatants were tested for lactate dehydrogenase (LDH), glucuronidase (GLU), and tumor necrosis factor α (TNFα) after 16 h of particle exposure. Hydrogen peroxide (H2O2) production was assessed after 90 min.
Overall, the effects of the four zeolites were heterogeneous and comparatively low when compared to natural aluminosilicates such as bentonite or kaolin studied with the same experimental setup.
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