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EC number: 305-230-8 | CAS number: 94350-12-6
- 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:
- From 05/02/2018 to 06/03/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- Version 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- other: dry powder module
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- 185.075 µm
- Geometric standard deviation:
- 0.738
- Remarks on result:
- other: % STDVP = percentage standard deviation of the population = 0.4%
- Key result
- Percentile:
- D10
- Mean:
- 43.232 µm
- St. dev.:
- 0.219
- Remarks on result:
- other: % STDVP = percentage standard deviation of the population=0.5%
- Key result
- Percentile:
- D90
- Mean:
- 400.038 µm
- St. dev.:
- 7.283
- No.:
- #1
- Size:
- 6 µm
- Distribution:
- 0.07 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #2
- Size:
- 10 µm
- Distribution:
- 0.59 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #3
- Size:
- 17.825 µm
- Distribution:
- 2.2 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #4
- Size:
- 31.698 µm
- Distribution:
- 6.25 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #5
- Size:
- 53 µm
- Distribution:
- 13.23 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #6
- Size:
- 90 µm
- Distribution:
- 25.83 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #7
- Size:
- 158.866 µm
- Distribution:
- 48.84 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #8
- Size:
- 282.508 µm
- Distribution:
- 77.02 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #9
- Size:
- 500 µm
- Distribution:
- 95.44 %
- Remarks on result:
- other: Average on 5 runs
- No.:
- #10
- Size:
- 893.367 µm
- Distribution:
- 100 %
- Remarks on result:
- other: Average on 5 runs
- Conclusions:
- The mass median aerodynamic diameter is 185.075 µm and the D50 is 162.697 ± 0.649 µm .
- Executive summary:
The particle size distribution of Saccharomyces Cerevisiae, Lysate was determined accoding to ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, and compliant with GLP.
The test was performed on the sample as received using the Laser Diffraction Particle Size Analyser. The particle size was analysed over the range 0.02 μm to 2000 μm and 5 runs were conducted.
The mass median aerodynamic diameter is 185.075 µm. The D10 is 43.232 ± 0.219 µm , the D50 is 162.697 ± 0.649 µm and the D90 is 400.038 ± 7.283 µm. The coefficients of variation show a good repeatability with 0.5%, 0.4% and 1.8% respectively, within the acceptable limits of the ISO method.
The particle size distibution study is classified as acceptable, and satisfies the guideline requirements of the ISO 13320:2009.
Reference
Full Test Results
|
RUN 1 |
RUN 2 |
RUN 3 |
RUN 4 |
RUN 5 |
Average** |
Volumeweightedmean |
185.619 |
193.000 |
200.503 |
197.886 |
196.872 |
196.622 |
Median |
163.176 |
161.796 |
163.651 |
162.554 |
162.333 |
162.697 |
Mode |
201.283 |
198.069 |
194.220 |
194.756 |
194.085 |
196.440 |
MMAD* |
185.619 |
184.050 |
186.160 |
184.912 |
184.661 |
185.075 |
d10 - 10 % ofmaterialis< |
42.936 |
43.133 |
43.515 |
43.120 |
43.455 |
43.232 |
d50 - 50 % ofmaterialis< |
163.176 |
161.796 |
163.651 |
162.554 |
162.333 |
162.697 |
d90 - 90 % ofmaterialis< |
394.547 |
391.169 |
411.997 |
403.736 |
399.980 |
400.038 |
All results are in μm
* Mass median aerodynamic diameter
** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
0.59 % by volume of sample was seen to be < 10.00μm
Standard Deviation result
|
STDVP |
% STDVP |
d10 - 10 % of material is < |
0.219 |
0.5 |
d50 - 50 % of material is < |
0.649 |
0.4 |
d90 - 90 % of material is < |
7.283 |
1.8 |
GSD |
0.015 |
0.5 |
MMAD |
0.738 |
0.4 |
GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78)
STDVP = standard deviation of the population
% STDVP = percentage standard deviation of the population
Description of key information
The mass median aerodynamic diameter is 185.075 µm and the D50 is 162.697 ± 0.649 µm .
Additional information
The particle size distribution of Saccharomyces Cerevisiae, Lysate was determined accoding to ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, and compliant with GLP.
The test was performed on the sample as received using the Laser Diffraction Particle Size Analyser. The particle size was analysed over the range 0.02 μm to 2000 μm and 5 runs were conducted.
The mass median aerodynamic diameter is 185.075 µm. The D10 is 43.232 ± 0.219 µm , the D50 is 162.697 ± 0.649 µm and the D90 is 400.038 ± 7.283 µm. The coefficients of variation show a good repeatability with 0.5%, 0.4% and 1.8% respectively, within the acceptable limits of the ISO method.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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