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EC number: 224-594-8 | CAS number: 4422-95-1
- 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
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:
- 15-03-2022 to 23-05-2022
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study conducted to recognised guidelines and guidance under GLP. All relevant validity criteria were met, with the exception of the 'repeatability criteria'. Applicant assessment indicates: the study can be considered acceptable with restrictions. This was given the corrosivity of the test item observed to equipment within the dry powder dispersion laser diffraction analysis study, and/or the inability to disperse in suitable non-aqueous solvents to test using wet module it can be considered the test item was satisfactorily tested. This is also with reference to the conclusion that the test item could be considered: inhalable under OECD 39 (2018). The proportion of test item having an inhalable particle size of < 100 μm was determined to be less than or equal to 3.55 % w/w using the laser diffraction analysis method - dry powder dispersion. Although the thoracic and respirable fractions appear non-existent due to absence of test item with < 10 μm particle size.
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- yes
- Remarks:
- Repeatability criteria not fulfilled, refer to 'Rationale for reliability incl. deficiencies' and/or 'Overall remarks, attachments' and 'Applicant's summary and conclusion' ; the test item was satisfactorily tested considering its corrosive properties.
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Version / remarks:
- “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007
- Deviations:
- yes
- Remarks:
- Repeatability criteria not fulfilled, refer to 'Rationale for reliability incl. deficiencies' and/or 'Overall remarks, attachments' and 'Applicant's summary and conclusion' ; the test item was satisfactorily tested considering its corrosive properties.
- GLP compliance:
- yes
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Remarks:
- The test item appeared to be white to pale yellow crystalline powder with some agglomerations. Lumps/agglomerations were carefully pulverised with a spatula to achieve a more constant distribution of the test material into the system prior to measurement.
- Mass median aerodynamic diameter:
- ca. 1 263 µm
- Geometric standard deviation:
- ca. 2.323
- Remarks on result:
- other: Information for Aero S module for dry powder dispersion: average MMAD: 1263 µm and average GSD 2.323 (GSD range: 2.131 - 2.509) where: n=6 ; See 'overall remarks, attachments' for further information.
- Key result
- Percentile:
- D10
- Mean:
- 298 µm
- St. dev.:
- 57.4
- Remarks on result:
- other: n=6 ; average D10: 298 µm ; %STDVP was > 3% - see 'overall remarks, attachments' for further information.
- Key result
- Percentile:
- D50
- Mean:
- ca. 980 µm
- St. dev.:
- 56.3
- Remarks on result:
- other: n=6 ; average D50: 980 µm ; %STDVP was > 2.5% - see 'overall remarks, attachments' for further information.
- Key result
- Percentile:
- D90
- Mean:
- ca. 2 150 µm
- St. dev.:
- 57.5
- Remarks on result:
- other: n=6 ; average D90: 2150 µm ; %STDVP was < 4% - see 'overall remarks, attachments' for further information.
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- <= 3.55 %
- Remarks on result:
- other: The proportion of test item having an inhalable particle size of < 100 μm was determined to be < or = 3.55 % w/w (via the particle size histogram presented in the full study report) - see 'overall remarks, attachments' for further information
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- 0 %
- Remarks on result:
- other: The proportion of test item having an inhalable particle size of < 10 μm (thoracic fraction) was determined to be 0 % w/w (at < 9.86 μm actual).
- No.:
- #3
- Size:
- < 1 µm
- Distribution:
- 0 %
- Remarks on result:
- other: The proportion of test item having an inhalable particle size of < 1 μm (respirable fraction) was determined to be 0 % w/w .
- Conclusions:
- The test item contains particles with particle sizes above 3500 µm which could not be analysed. The proportion of test item having an inhalable particle size of < 100 μm was determined to be less than or equal to 3.55 % w/w using the laser diffraction analysis method - dry powder dispersion. Repeat testing was not possible due to test item corrosivity and visible damage to the test system. The test item could be considered: inhalable. Although the thoracic and respirable fractions appear non-existent due to absence of test item with < 10 μm particle size. Laser diffraction analysis by wet module was not possible due to an inability to disperse in available non-aqueous solvents and test item incompatibility with aqueous solvents.
- Executive summary:
The test item particle size was evaluated using laser diffraction analysis according to ISO 13320 : 2009 “Particle Size Analysis – Laser Diffraction Methods” and/or CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K (2007) under GLP. The test item appeared to be white to pale yellow crystalline powder with some agglomerations (determined by the test facility). The test is conducted to determine the particle size distribution of the test item by means of Laser Diffraction Analysis, using the Aero S for dry powder dispersion. Various tests were performed to determine the correct parameters, most suitable feed procedure and dispersion pressures and once identified the test item was analysed using the Malvern Mastersizer 3000 Laser Diffraction Analyser. Six (n=6) runs were conducted to ensure repeatability of results. During initial testing, large lumps or agglomerations were formed within the test item container. The test system became blocked by the lumps causing measurements to halt. Therefore, the test item lumps/agglomerations were carefully pulverised with a spatula to achieve a more constant distribution of the material into the system prior to further measurement. The lumps/agglomeration pre-treatment was carefully focused on lumps/agglomeration break-up and not on pulverising the powdered/granular test item.
The test item contains particles with particle sizes above 3500 µm which could not be analysed.
The test item had the following averaged properties following six runs (n=6) :
MMAD (mass median aerodynamic diameter) 1263 μm
d10 - 10 % of material is 298 μm
d50 - 50 % of material is 980 μm
d90 - 90 % of material is 2150 μm
volume of sample < 10.00 μm: 0%
It was noted the %STDVP for D50 was > 2.5%, for D10 > 3% and for D90 < 4%. It can be concluded that the repeatability of the measured particle size distributions is above the acceptable limits proscribed by the applicable guidelines. Although the repeatability was not within the acceptance criteria for the D10 and D50, repetition of the measurement could not be completed due to the corrosiveness of the test item and visible corrosion damage caused to the test system. Further testing using Particle Size Analysis (Wet Module) could not be performed. The test item has incompatibility with aqueous solvents and may form corrosive solutions. Therefore, aqueous solvents could not be utilised. With the limited number of potential solvents, including: Corn oil, Peanut oil, Isoparaffin G, PEG300 and Silicone Oil, were tested and found to give poor dispersibility of the test item (was seen to ‘sink to the bottom’ of the sample/solvent container). It was determined there was no suitable dispersant that could be used for particle size analysis using the wet module. Further testing could not be performed. It can be concluded, the proportion of test item having an inhalable particle size of < 100 μm was determined to be less than or equal to 3.55 % w/w using the laser diffraction analysis method - dry powder dispersion. The test item could be considered: inhalable. Although the thoracic and respirable fractions appear non-existent due to absence of test item with < 10 μm particle size.
Reference
1. The particle size distribution of the test item was analysed over the range 0.01 µm to 3500 µm. Analysis of the generated results indicates the test item contains particles with particle sizes above 3500 µm. However, due to the limitations of the Laser Diffraction analyzer equipment, this could not be confirmed.
2. See tables for detailed information on results. It was noted the %STDVP for D50 was > 2.5%, for D10 > 3% and for D90 < 4%. It can be concluded that the repeatability of the measured particle size distributions is above the acceptable limits proscribed by the applicable guidelines. Although the repeatability was not within the acceptance criteria for the D10 and D50, it was decided not to repeat the measurement due to the corrosiveness of the test item and visible corrosion damage caused to the test system. Further testing using Dry Powder Dispersion could not be performed.
Table 1: Test results - Particle Size Analysis (Dry Powder Dispersion)
| Run 1 | Run 2 | Run 3 | Run 4 | Run 5 | Run 6 | Mean | STDVP | %STDVP |
Volume weighted mean | 1110 | 1090 | 1220 | 1090 | 1110 | 1080 | 1120 | 51.6 | 4.62 |
Mode | 1160 | 1170 | 1220 | 1080 | 1080 | 1090 | 1130 | 59.3 | 5.22 |
D10 (10% of material is ≤) | 275 | 236 | 399 | 283 | 326 | 270 | 298 | 57.4 | 19.3 |
D50 (50% of material is ≤) | 979 | 950 | 1090 | 951 | 976 | 933 | 980 | 56.3 | 5.74 |
D90 (90% of material is ≤) | 2170 | 2160 | 2260 | 2110 | 2120 | 2100 | 2150 | 57.5 | 2.67 |
GSD | 2.381 | 2.509 | 2.131 | 2.362 | 2.210 | 2.343 | 2.323 | 0.134 | 5.758 |
MMAD | 1263 |
All results are in µm.
0% by volume of sample was seen to be < 10.00 µm.
Description of key information
Particle Size Distribution: ca. 3.55% w/w with particle size < 100 μm, no particles < 10 μm, ISO 13320 : 2009 - Laser Diffraction Analysis - Dry Powder Dispersion module, 2022
The test item contains particles with particle sizes above 3500 µm which could not be analysed.
The test item had the following averaged properties following six runs (n=6) :
MMAD (mass median aerodynamic diameter) 1263 μm
d10 - 10 % of material is 298 μm
d50 - 50 % of material is 980 μm
d90 - 90 % of material is 2150 μm
volume of sample < 10.00 μm: 0%
It was noted the %STDVP for D50 was > 2.5%, for D10 > 3% and for D90 < 4%. It can be concluded that the repeatability of the measured particle size distributions is above the acceptable limits proscribed by the applicable guidelines. Although the repeatability was not within the acceptance criteria for the D10 and D50, repetition of the measurement could not be completed due to the corrosiveness of the test item and visible corrosion damage caused to the test system. Further testing using Particle Size Analysis (Wet Module) could not be performed. With the limited number of potential solvents, including: Corn oil, Peanut oil, Isoparaffin G, PEG300 and Silicone Oil, were tested and found to give poor dispersibility of the test item (was seen to ‘sink to the bottom’ of the sample/solvent container).
Applicant asseessment indicates that: a regulatory conclusion to the study was, the proportion of test item having an inhalable particle size of < 100 μm was determined to be less than or equal to 3.55 % w/w using the laser diffraction analysis method - dry powder dispersion. The test item could be considered: inhalable under OECD 39 (2018). Although the thoracic and respirable fractions appear non-existent due to absence of test item with < 10 μm particle size.
Additional information
Key study : ISO 13320 : Laser Diffraction Analysis - Dry Powder Dispersion module, 2022 : The test item particle size was evaluated using laser diffraction analysis according to ISO 13320 : 2009 “Particle Size Analysis – Laser Diffraction Methods” and/or CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K (2007) under GLP. The test item appeared to be white to pale yellow crystalline powder with some agglomerations (determined by the test facility). The test is conducted to determine the particle size distribution of the test item by means of Laser Diffraction Analysis, using the Aero S for dry powder dispersion. Various tests were performed to determine the correct parameters, most suitable feed procedure and dispersion pressures and once identified the test item was analysed using the Malvern Mastersizer 3000 Laser Diffraction Analyser. Six (n=6) runs were conducted to ensure repeatability of results. During initial testing, large lumps or agglomerations were formed within the test item container. The test system became blocked by the lumps causing measurements to halt. Therefore, the test item lumps/agglomerations were carefully pulverised with a spatula to achieve a more constant distribution of the material into the system prior to further measurement. The lumps/agglomeration pre-treatment was carefully focused on lumps/agglomeration break-up and not on pulverising the powdered/granular test item.
The test item contains particles with particle sizes above 3500 µm which could not be analysed.
The test item had the following averaged properties following six runs (n=6) :
MMAD (mass median aerodynamic diameter) 1263 μm
d10 - 10 % of material is 298 μm
d50 - 50 % of material is 980 μm
d90 - 90 % of material is 2150 μm
volume of sample < 10.00 μm: 0%
It was noted the %STDVP for D50 was > 2.5%, for D10 > 3% and for D90 < 4%. It can be concluded that the repeatability of the measured particle size distributions is above the acceptable limits proscribed by the applicable guidelines. Although the repeatability was not within the acceptance criteria for the D10 and D50, repetition of the measurement could not be completed due to the corrosiveness of the test item and visible corrosion damage caused to the test system. Further testing using Particle Size Analysis (Wet Module) could not be performed. The test item has incompatibility with aqueous solvents and may form corrosive solutions. Therefore, aqueous solvents could not be utilised. With the limited number of potential solvents, including: Corn oil, Peanut oil, Isoparaffin G, PEG300 and Silicone Oil, were tested and found to give poor dispersibility of the test item (was seen to ‘sink to the bottom’ of the sample/solvent container). It was determined there was no suitable dispersant that could be used for particle size analysis using the wet module. Further testing could not be performed. It can be concluded, the proportion of test item having an inhalable particle size of < 100 μm was determined to be less than or equal to 3.55 % w/w using the laser diffraction analysis method - dry powder dispersion. The test item could be considered: inhalable. Although the thoracic and respirable fractions appear non-existent due to absence of test item with < 10 μm particle size.
Applicant assessment indicates: the study can be considered acceptable with restrictions. This was given the corrosivity of the test item observed to equipment within the dry powder dispersion laser diffraction analysis study, and/or the inability to disperse in suitable non-aqueous solvents to test using wet module it can be considered the test item was satisfactorily tested. This is also with reference to the conclusion that the test item could be considered: inhalable under OECD 39 (2018). Although the thoracic and respirable fractions appear non-existent due to absence of test item with < 10 μm particle size.
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