Registration Dossier
Registration Dossier
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EC number: 237-952-3 | CAS number: 14100-64-2
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- no
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Remarks:
- with dry dispersion
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Percentile:
- D10
- Mean:
- 56.6 µm
- St. dev.:
- 0
- Remarks on result:
- other: Standard deviation not reported
- Key result
- Percentile:
- D50
- Mean:
- 97.3 µm
- St. dev.:
- 0
- Remarks on result:
- other: Standard deviation not reported
- Percentile:
- D90
- Mean:
- 159.3 µm
- St. dev.:
- 0
- Remarks on result:
- other: Standard deviation not reported
- Conclusions:
- The registered substance is not placed on the market as a discrete substance powder, but as a component in a mixture. Downstream users will not be exposed to the pure substance. For this reason it was decided that granulometry studies should focus on the product as placed on the market rather than individual reference substance powders.
The D10 particle size for the marketed product was determined to be 56.6 µm, D50 was 97.3 µm and D90 was 159.3 µm. - Executive summary:
Johnson Matthey (2017) is not GLP compliant but followed a standard test method and guideline (ISO 13320 laser diffraction) and is considered reliable with restrictions (Klimisch 2).
The registered substance is not placed on the market as a discrete substance powder, but as a component in a mixture. Downstream users will not be exposed to the pure substance. For this reason it was decided that granulometry studies should focus on the product as placed on the market rather than individual reference substance powders.
The D10 particle size for the marketed product was determined to be 56.6 µm, D50 was 97.3 µm and D90 was 159.3 µm.
Reference
Description of key information
The registered substance is not placed on the market as a discrete substance powder, but as a component in a mixture. Downstream users will not be exposed to the pure substance. For this reason it was decided that granulometry studies should focus on the product as placed on the market rather than individual reference substance powders.
The D10 particle size for the marketed product was determined to be 56.6 µm, D50 was 97.3 µm and D90 was 159.3 µm.
Additional information
Johnson Matthey (2017) is not GLP compliant but followed a standard test method and guideline (ISO 13320 laser diffraction) and is considered reliable with restrictions (Klimisch 2).
The registered substance is not placed on the market as a discrete substance powder, but as a component in a mixture. Downstream users will not be exposed to the pure substance. For this reason it was decided that granulometry studies should focus on the product as placed on the market rather than individual reference substance powders.
The D10 particle size for the marketed product was determined to be 56.6 µm, D50 was 97.3 µm and D90 was 159.3 µm.
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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