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EC number: 266-340-9 | CAS number: 66402-68-4 This category encompasses the various chemical substances manufactured in the production of ceramics. For purposes of this category, a ceramic is defined as a crystalline or partially crystalline, inorganic, non-metallic, usually opaque substance consisting principally of combinations of inorganic oxides of aluminum, calcium, chromium, iron, magnesium, silicon, titanium, or zirconium which conventionally is formed first by fusion or sintering at very high temperatures, then by cooling, generally resulting in a rigid, brittle monophase or multiphase structure. (Those ceramics which are produced by heating inorganic glass, thereby changing its physical structure from amorphous to crystalline but not its chemical identity are not included in this definition.) This category consists of chemical substances other than by-products or impurities which are formed during the production of various ceramics and concurrently incorporated into a ceramic mixture. Its composition may contain any one or a combination of these substances. Trace amounts of oxides and other substances may be present. The following representative elements are principally present as oxides but may also be present as borides, carbides, chlorides, fluorides, nitrides, silicides, or sulfides in multiple oxidation states, or in more complex compounds.@Aluminum@Lithium@Barium@Magnesium@Beryllium@Manganese@Boron@Phosphorus@Cadmium@Potassium@Calcium@Silicon@Carbon@Sodium@Cerium@Thorium@Cesium@Tin@Chromium@Titanium@Cobalt@Uranium@Copper@Yttrium@Hafnium@Zinc@Iron@Zirconium
- 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

Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-08-17 - 2009-12-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
- Type of study / information:
- Determination of the resorption in the lung of pleonastic spinel in order to determine the bio-accessible parts
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: „Bioaccessibility testing of Cobalt compounds", Woodhall Stopford at al., J. Environ. Monit. 5, 2003, 675 - 680
- Deviations:
- yes
- Remarks:
- Shaking was performed for two hours only in order to prevent too high temperatures in the incubator. As no dissolution was observed in the first flasks, this is considered as uncritical concerning the outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ceramic materials and wares, chemicals
- EC Number:
- 266-340-9
- EC Name:
- Ceramic materials and wares, chemicals
- Cas Number:
- 66402-68-4
- Molecular formula:
- spinel of the pleonaste type containing (Mg,Fe)(Al,Fe)2O4
- IUPAC Name:
- not applicable
Constituent 1
Results and discussion
Any other information on results incl. tables
Calculation of Mobilised Mass
The mobilised masses of the two elements were calculated from
wi,mob = (Ci * V)/mE
with
wi,mob = mobilised part in µg/g test item per element
Ci = measured element concentration in µg/L
V = total volume in L of the aqueous phase (0.05 L in all samples)
mE = weight of used test item (nominal: 1.0 g, real weights were used for calc.)
Bioaccessibility was calculated as
Ri = (wi,mob * 100%)/wi,total
with
Ri = bioaccessible part in %
wi,mob = mobilised part in µg/g test item per element
wi,total = total part of the respective element in the test item in µg/g
As the concentrations of Al in the blanks and in the tests lower than LOQ (Al), calculation of a limit bio-accessibility for Al was based on the LOQ.
Bioaccessible Part Al, summary (determined from LOQ Al, 0.25 mg/l) |
Parameter |
Mean |
Mobilised mass of test item in µg/g |
<11.9 |
Bioaccessibility in % |
<6.13*10-5 |
As the concentrations of Fe in the blanks and in the first samples (1-6) were lower than LOQ (Fe), calculation of a limit bio-accessibility for Fe was based on the samples 7 and 8 (taken after 72h).
Bioaccessible Part Fe, summary
Parameter |
Mean(72h) |
Standard Deviation |
Relative Standard Deviation(%) |
Mobilised mass of test item in µg/g |
2.17 |
0.14 |
6.6% |
Limit Bioaccessibility in % |
1.19* 10-5 |
7.80 *10-7 |
6.6% |
BioaccessiblePart Mg,summary |
Parameter |
Mean(72h) |
Standard Deviation |
Relative Standard Deviation(%) |
Mobilised mass of test item in µg/g |
6865 |
77.99 |
1% |
Bioaccessibility in % |
3.25* 10 -2 |
3.70 *10 -4 |
1% |
Applicant's summary and conclusion
- Conclusions:
- The test item was incubated in synthetical lung fluid (Modified Gambles solution) for a period of three days. Incubation temperature was 37 °C, atmosphere contained 5% CO2.
Samples were taken after 2, 5, 24 and 72 hours incubation time. At each sampling, two flasks were opened and filtrated through 0.45-µm membrane filters. Concentration of the test item was measured using flame AAS after addition of 1% (V/V) conc. HCI. The blanks were analysed at the last sampling point only.
All Al concentrations lay below LOQ.
In two samples (7, 8), Fe values were higher than LOQ. These were used for the determination of a bio-accessibility limit.
Because of the presence of Mg in blanks of the synthetical lung fluid, the bioaccessibility was determined from Al- and Fe-content only.
Bioaccessibility from Al content: < 6.13 E-5 %
Bioaccessibilty from Fe content: 1.19 E-5 % - Executive summary:
The test item was incubated in synthetical lung fluid (Modified Gambles solution) for a period of three days. Incubation temperature was 37 °C, atmosphere contained 5% CO2. Samples were taken after 2, 5, 24 and 72 hours incubation time. At each sampling, two flasks were opened and filtrated through 0.45-µm membrane filters. Concentration of the test item was measured using flame AAS after addition of 1% (V/V) conc. HCI. The blanks were analysed at the last sampling point only. All Al concentrations lay below LOQ. In two samples (7, 8), Fe values were higher than LOQ. These were used for the determination of a bio-accessibility limit. Because of the presence of Mg in blanks of the synthetical lung fluid, the bioaccessibility was determined from Al- and Fe-content only.
Parameter Al
Mean*
Mobilised mass of test item
<11.9 µg/g
Bioaccessibility
< 6.13 * 10 -5%
*determinated from LOQ Al,0.25mg/L
Parameter Fe
Mean(72h)
Standard Deviation
Relative Standard Deviation(%)
Mobilised mass of test item
2.17 µg/g
0.14 µg/g
6.6%
Bioaccessibility %
1.19 *10-5%
7.80 * 10 -7 %
6.6%
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