Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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:
- May - September 2020
- 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:
- 1.12.2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Specific details on test material used for the study:
- Appearance: white powder
- Mass median aerodynamic diameter:
- 526.69 µm
- Geometric standard deviation:
- 19.26
- Percentile:
- D10
- Mean:
- 107.09 µm
- St. dev.:
- 3.48
- Remarks on result:
- other: GRADIS method
- Remarks:
- Agglomerates
- Percentile:
- D50
- Mean:
- 526.69 µm
- St. dev.:
- 19.26
- Remarks on result:
- other: GRADIS method
- Remarks:
- Agglomerates
- Percentile:
- D90
- Mean:
- 1 072.87 µm
- St. dev.:
- 33.7
- Remarks on result:
- other: GRADIS method
- Remarks:
- Agglomerates
- Percentile:
- D10
- Mean:
- >= 3.93 - <= 4.28 µm
- Remarks on result:
- other: RODOS/L 4 bar
- Remarks:
- primary particles
- Percentile:
- D50
- Mean:
- >= 68.08 - <= 84.39
- Remarks on result:
- other: RODOS/L - 4 bar
- Remarks:
- primary particles
- Percentile:
- D90
- Mean:
- >= 269.71 - <= 370.04
- Remarks on result:
- other: RODOS/L 4 bar
- Remarks:
- primary particles
- Conclusions:
- The test item AM(pfa)4 has a median particle size D50 = 526.69 ± 19.26 µm at the dispersion method GRADIS/L.
Due to particle size decrease with increasing pressure (1, 2 and 4 bar) in RODOS/L measurements, the GRADIS/L results are considered to reflect agglomerate size values. For primary particle size, the lowest determined values at 4 bar using the RODOS/L method (D50 = 68.08 – 84.39 µm) are considered representative. - Executive summary:
The test item AM(pfa)4 has a median particle size D50 = 526.69 ± 19.26 µm at the dispersion method GRADIS/L, a median particle size D50 = 117.86 ± 3.05 µm at the dispersion method RODOS/L with a dispersion pressure 1 bar, a median particle size D50 = 75.97 – 116.94 µm at the dispersion method RODOS/L with a dispersion pressure 2 bar and a median particle size D50 = 68.08 – 84.39 µm at the dispersion method RODOS/L with a dispersion pressure 4 bar.
The average particle size distribution of the test methods GRADIS/L and RODOS/L are also provided in the following table:
Table Particle size distribution Overview
GRADIS
Particle size
D10 (µm)
D50 (µm)
D90 (µm)
Value
107.09
526.69
1072.87
Standard deviation
3.48
19.26
33.70
RODOS/L- 1 bar
Particle size
D10 (µm)
D50 (µm)
D90 (µm)
Value
11.63
117.86
376.72
Standard deviation
0.13
3.05
6.01
RODOS/L- 2 bar
Particle size
D10 (µm)
D50 (µm)
D90 (µm)
Value
6.75 – 8.92
75.97 – 116.94
276.56 – 381.77
RODOS/L- 4 bar
Particle size
D10 (µm)
D50 (µm)
D90 (µm)
Value
3.93 – 4.28
68.08 – 84.39
269.71 – 370.04
The particle size distribution of the dry weak dispersion test method GRADIS/L showed that the particles, as they exist, were agglomerated. The particle size distribution of the dry intense dispersion test method RODOS/L showed that the particles could be dispersed by the dispersion pressure to smaller particles.
The particle size became slightly smaller particles with increasing dispersion pressure. The measurements of RODOS – 2 bar and RODOS- 4 bar showed wide ranges of the particle distribution for D10, D50 and D90 with smaller particle size but also higher particle sizes. This could be due to the behaviour of the particles (e.g. inhomogeneous particle distribution and strongly agglomerated particles). Also, the results could be explained by some agglomerates being quite robust whereas others are not that can be already strongly dispersed with weak dispersion pressure. However, the change in particle size with increasing dispersion pressure could have also been caused by particle destruction.
No observations were made which might cause doubts on the validity of the study outcome. Therefore, the result of the study is considered valid.
Reference
Verification and calibration: Every measuring cell was checked with the corresponding reference substance. As different ranges (Range 1, Range 3 and Range 5) could be used, the different ranges were also checked with the corresponding reference substance. The following ranges were used for following test methods: GRADIS/L weak dry dispersion with range 7 and RODOS/L intense dry dispersion with range 5. For both methods and range a reference sample (SiC) was measured as reference substance.
Pre-Tests: The test item was visually inspected prior to the measurement (visual, by microscope). No particles were larger than 2800 µm.
Particle Size Distribution
Dry dispersion method GRADIS/L: For each dispersion method 4 measurements were performed with the test substance. The sample flow of the singular measurement 1 was too high. Therefore, the measurement 1 was only used to adjust the parameter for an optimal obscuration and measurement. This measurement was not used for evaluation and not reported in the final report. The results of measurements 2 - 4 were given in the following table.
Table 1a: Particle size distribution of test method GRADIS/L
GRADIS/L |
Measurement |
D10 (µm) |
D50 (µm) |
D90 (µm) |
No. 2 |
107.79 |
515.41 |
1044.51 |
|
No. 3 |
110.17 |
548.92 |
1110.13 |
|
No. 4 |
103.31 |
515.72 |
1063.97 |
The Averaged Particle Size was calculated by the instrument as follows:
Table 1b Average particle size distribution of test method GRADIS/L
Particle size |
D10 (µm) |
D50 (µm) |
D90 (µm) |
Value |
107.09 |
526.69 |
1072.87 |
Standard deviation |
3.48 |
19.26 |
33.70 |
The width of distribution for the test substance with the test method GRADIS/L is for D10 103.31 – 110.17 µm, for D50 515.41 – 548.92 µm and for D90 1044.51 – 1110.13 µm.
Dry dispersion method RODOS/L:
First measurement series – 1 bar: For the dispersion method 4 measurements were performed with the test substance. The sample flow of the singular measurement 1 was too low. Therefore, the measurement 1 was only used to adjust the parameter for an optimal obscuration and measurement. This measurement was not used for evaluation and not reported in the final report. The results of measurements 2 - 4 are given in the following table:
Table 2a Particle size distribution of test method RODOS/L 1 bar
RODOS/L 1 bar |
Measurement |
D10 (µm) |
D50 (µm) |
D90 (µm) |
No. 2 |
11.78 |
114.64 |
370.19 |
|
No. 3 |
11.53 |
120.71 |
382.02 |
|
No. 4 |
11.58 |
118.23 |
377.94 |
The Averaged Particle Size was calculated by the instrument as follows:
Table 2-b Average particle size distribution of test method RODOS/L 1 bar
Particle size |
D10 (µm) |
D50 (µm) |
D90 (µm) |
Value |
11.63 |
117.86 |
376.72 |
Standard deviation |
0.13 |
3.05 |
6.01 |
The width of distribution for the test item with the test method RODOS/L - 1 bar is for D10 11.53 – 11.78 µm, for D50 114.64 – 120.71 µm and for D90 370.19 – 382.02 µm.
Second measurement series – 2 bar: For the dispersion method 7 measurements were performed with the test substance. At the fifth and sixth measurement the sample flow was blocked. Therefore, these measurements were not used for evaluation and the data is not provided in the final report, but archived with the raw data of the study in the GLP-archive of the test facility. The results of measurements 1 – 4 and 7 are are given in the following table:
Table 3-a Particle size distribution of test method RODOS/L 2 bar
RODOS/L 2 bar |
Measurement |
D10 (µm) |
D50 (µm) |
D90 (µm) |
No. 1 |
6.75 |
75.97 |
276.56 |
|
No. 2 |
8.54 |
109.60 |
373.93 |
|
No. 3 |
7.61 |
89.80 |
290.43 |
|
No. 4 |
8.92 |
116.94 |
381.77 |
|
No. 7 |
8.23 |
103.89 |
359.69 |
5 individual measurements were performed. As the distribution of the values is too high due to the behaviour of the particles (e.g. in-homogeneous particle distribution, agglutination etc.) and therefore no mean value with a deviation below 5 % can be calculated, the collected valid measured values are given as a range. The width of distribution for the test item with the test method RODOS/L- 2 bar is for D10 6.75 – 8.92 µm, for D50 75.97 – 116.94 µm and for D90 276.56 – 381.77 µm.
Third measurement series – 4 bar: For the dispersion method 6 measurements were performed with the test substance. At the fifth measurement the sample flow was blocked. Therefore, this measurement was not used for evaluation and the data is not provided in the final report, but archived with the raw data of the study in the GLP-archive of the test facility.
The results of measurements 1 – 4 and 6 are given in the following table:
Table 8.4-a Particle size distribution of test method RODOS/L 4 bar
RODOS/L 4 bar |
Measurement |
D10 (µm) |
D50 (µm) |
D90 (µm) |
No. 1 |
4.28 |
68.08 |
270.46 |
|
No. 2 |
4.28 |
69.04 |
269.71 |
|
No. 3 |
4.25 |
75.11 |
287.62 |
|
No. 4 |
4.09 |
75.75 |
289.37 |
|
No. 6 |
3.93 |
84.39 |
370.04 |
5 individual measurements were performed. As the distribution of the values is too high due to the behaviour of the particles (e.g. in-homogeneous particle distribution, agglutination etc.) and therefore no mean value with a deviation below 5 % can be calculated, the collected valid measured values are given as a range. The width of distribution for the test item with the test method RODOS/L- 4 bar is for D10 3.93 – 4.28 µm, for D50 68.08 – 84.39 µm and for D90 269.71 – 370.04 µm.
Validity
The deviation between the singular measurements for the measurement of RODOS -1 bar did not exceed 5 % and for the measurement of GRADIS did not exceed 10 %. As the deviation of the measurements of RODOS -2 bar and RODOS- 4 bar did exceed 5 %, the values were given in a range. No observations were made which might cause doubts on the validity of the study out-come. Therefore, the result of the study is considered valid.
Description of key information
The test item AM(pfa)4 has a median particle size D50 = 526.69 ± 19.26 µm at the dispersion method GRADIS/L. Due to particle size decrease with increasing pressure (1, 2 and 4 bar) in RODOS/L measurements, the GRADIS/L results are considered to reflect agglomerate size values. For primary particle size, the lowest determined values at 4 bar using the RODOS/L method (D50 = 68.08 – 84.39 µm) are considered representative.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.