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EC number: 849-975-1 | 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
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 October 2007 to 02 October 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Directorate General XII-JRC, Science Research and Development - Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document ECB/TM/February 1996.
- Version / remarks:
- February 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Directorate General JRC, Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Draft Guidance Document EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”.
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- mass based distribution
- Mass median aerodynamic diameter:
- 1.6 µm
- Geometric standard deviation:
- 0.075
- Remarks on result:
- other: Geometric standard deviation not reported.
- Percentile:
- D10
- Mean:
- < 0.6 µm
- St. dev.:
- 0.035
- Percentile:
- D50
- Mean:
- < 1.6 µm
- St. dev.:
- 0.075
- Percentile:
- D90
- Mean:
- < 4.4 µm
- St. dev.:
- 0.166
- No.:
- #1
- Size:
- < 0.5 µm
- Distribution:
- 7 %
- No.:
- #2
- Size:
- < 1 µm
- Distribution:
- 27.75 %
- No.:
- #3
- Size:
- < 2 µm
- Distribution:
- 59.28 %
- No.:
- #4
- Size:
- < 3 µm
- Distribution:
- 77.24 %
- No.:
- #5
- Size:
- < 4 µm
- Distribution:
- 87.45 %
- No.:
- #6
- Size:
- < 5 µm
- Distribution:
- 93.36 %
- No.:
- #7
- Size:
- < 6 µm
- Distribution:
- 96.75 %
- No.:
- #8
- Size:
- < 7 µm
- Distribution:
- 98.6 %
- No.:
- #9
- Size:
- < 8 µm
- Distribution:
- 99.66 %
- No.:
- #10
- Size:
- < 9 µm
- Distribution:
- 99.97 %
- Conclusions:
- Under the conditions of the study the mass median diameter was determined to be 1.6 µm. The particle size was found to range from approximately 0.3 µm to 9.0 µm.
- Executive summary:
The particle size distribution of the test material was assessed according to European Commission Directorate General Guidance Document ECB/TM/February 1996 and the European Commission Directorate General JRC Draft Guidance Document EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction” in compliance with GLP.
Visual examinations were performed macroscopically and microscopically under magnification of 400, using a light microscope to judge the colour and structure of the test material.
A solubility test was performed to choose a suitable dispersing agent. During the solubility test, water containing 5 drops of Sympatens was selected as an appropriate dispersing agent for this study.
In the main test the dispersing apparatus was rinsed and filled with pre-saturated water containing 5 drops of Sympatens solution. A few mL of the stock solution dispersion were added slowly until the absorption of the laser was reduced by about 10 %. The particle size distribution in the suspension was quantified by laser diffraction. The test was performed with two samples of the stock solution dispersion and each measured in duplicate.
The test material is a fine yellow powder. Under the microscope (with a magnification of 400) partly agglutinated, fine-grained, crystalline structures were observed. After the mixture was sonicated for 5 min the test material was more evenly spread.
A solubility test showed that the test material is both sparingly soluble and well dispersible in water containing 5 drops Sympatens. The particle size distribution of the test material was performed with two samples of the stock dispersion each measured in duplicate.
The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.
Using the laser diffraction method to study the particle size ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 1.6 µm. The particle size was found to range from approximately 0.3 µm to 9.0 µm.
Reference
The test material is a fine yellow powder. Under the microscope (with a magnification of 400) partly agglutinated, fine-grained, crystalline structures were observed. After the mixture was sonicated for 5 min the test material was more evenly spread.
A solubility test showed that the test material is both sparingly soluble and well dispersible in water containing 5 drops Sympatens. The particle size distribution of the test material was performed with two samples of the stock dispersion each measured in duplicate.
The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.
Using the laser diffraction method to study the particle size ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 1.6 µm. The particle size was found to range from approximately 0.3 µm to 9.0 µm.
Particle Size Distribution of the Test Material
[%] |
1st Run particle size [µm] |
2nd Run particle size [µm] |
3rd Run particle size [µm] |
4th Run particle size [µm] |
Mean particle size [µm] |
Stand. Dev. [±] |
5 |
< 0.43 |
< 0.43 |
< 0.47 |
< 0.47 |
< 0.5 |
0.023 |
10 |
< 0.55 |
< 0.55 |
< 0.61 |
< 0.61 |
< 0.6 |
0.035 |
50 |
< 1.57 |
< 1.58 |
< 1.70 |
< 1.71 |
< 1.6* |
0.075 |
90 |
< 4.20 |
< 4.23 |
< 4.48 |
< 4.52 |
< 4.4 |
0.166 |
* The MMD of the test material indicates that 50 % (by mass) of the particles are smaller than 1.6 µm.
Particle Size Distribution of the Test Material in % at the Relevant Particle Size
[µm] |
1st Run [%] |
2nd Run [%] |
3rd Run [%] |
4th Run [%] |
Mean [%] |
Stand. Dev. [%] |
< 0.3 |
***** |
***** |
***** |
***** |
|
|
< 0.5 |
7.86 |
7.84 |
6.15 |
6.16 |
7.00 |
0.98 |
< 1.0 |
29.56 |
29.45 |
26.03 |
25.97 |
27.75 |
2.02 |
< 2.0 |
61.17 |
60.95 |
57.62 |
57.38 |
59.28 |
2.06 |
< 3.0 |
78.76 |
78.50 |
76.01 |
75.70 |
77.24 |
1.61 |
< 4.0 |
88.56 |
88.34 |
86.59 |
86.32 |
87.45 |
1.61 |
< 5.0 |
94.13 |
93.95 |
92.78 |
92.56 |
93.36 |
0.80 |
< 6.0 |
97.26 |
97.13 |
96.38 |
96.22 |
96.75 |
0.52 |
< 7.0 |
98.93 |
98.85 |
98.37 |
98.26 |
98.60 |
0.34 |
< 8.0 |
99.85 |
99.81 |
99.52 |
99.45 |
99.66 |
0.20 |
< 9.0 |
100.00 |
99.99 |
99.95 |
99.94 |
99.97 |
0.03 |
< 10.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 20.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 30.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 40.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 50.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 60.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 70.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 80.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 90.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 100.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 125.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 150.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 175.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 200.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 225.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 250.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 275.0 |
100.00 |
100.00 |
100.00 |
100.00 |
100.00 |
0.00 |
< 300.0 |
***** |
***** |
***** |
***** |
|
|
Description of key information
Under the conditions of the study the mass median diameter was determined to be 1.6 µm. The particle size was found to range from approximately 0.3 µm to 9.0 µm.
Additional information
The particle size distribution of the test material was assessed according to European Commission Directorate General Guidance Document ECB/TM/February 1996 and the European Commission Directorate General JRC Draft Guidance Document EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction” in compliance with GLP. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Visual examinations were performed macroscopically and microscopically under magnification of 400, using a light microscope to judge the colour and structure of the test material.
A solubility test was performed to choose a suitable dispersing agent. During the solubility test, water containing 5 drops of Sympatens was selected as an appropriate dispersing agent for this study.
In the main test the dispersing apparatus was rinsed and filled with pre-saturated water containing 5 drops of Sympatens solution. A few mL of the stock solution dispersion were added slowly until the absorption of the laser was reduced by about 10 %. The particle size distribution in the suspension was quantified by laser diffraction. The test was performed with two samples of the stock solution dispersion and each measured in duplicate.
The test material is a fine yellow powder. Under the microscope (with a magnification of 400) partly agglutinated, fine-grained, crystalline structures were observed. After the mixture was sonicated for 5 min the test material was more evenly spread.
A solubility test showed that the test material is both sparingly soluble and well dispersible in water containing 5 drops Sympatens. The particle size distribution of the test material was performed with two samples of the stock dispersion each measured in duplicate.
The results obtained during the measurements showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.
Using the laser diffraction method to study the particle size ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 1.6 µm. The particle size was found to range from approximately 0.3 µm to 9.0 µm.
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