Registration Dossier
Registration Dossier
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EC number: 909-709-8 | CAS number: -
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:
- 08/25/2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Internal company study, not carried out in compliance with GLP.
- Remarks:
- However, the test was performed using methods highly adapted to the in-house products. Furthermore, the laser diffraction method here applied is recommended in internationally recognised guidelines.
- Principles of method if other than guideline:
- The laser scattering/diffraction method is an internationally accepted method and considered suitable to determine the distribution of particles of respirable and inhalable size (ECHA Endpoint specific guidance, Chapter R.7a).
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Percentile:
- D10
- Mean:
- 1.103 µm
- Remarks on result:
- other: no more information
- Key result
- Percentile:
- D50
- Mean:
- 2.557 µm
- Remarks on result:
- other: no more information
- Percentile:
- D90
- Mean:
- 7.125 µm
- Remarks on result:
- other: no more information
- Conclusions:
- The reaction mass of cerium dioxide and zirconium dioxide presents a D50 of 2.557 µm.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 15-JUN-2010 to 16-JUN-2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: These data are based on an internal company study.
- Remarks:
- The study was not carried out in compliance with GLP. However, the tests were performed using methods highly adapted to the in-house products. Furthermore, the laser diffraction method here applied is recommended in internationally recognised guidelines.
- Qualifier:
- equivalent or similar 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 DRAFT guidance document EUR 20268 EN (2002), Part 5.2 "Laser scattering / diffraction"
- Qualifier:
- equivalent or similar 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 ECBITM/ February 1996
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- counted distribution
- Percentile:
- D10
- Mean:
- 0.649 µm
- Remarks on result:
- other: no more information
- Key result
- Percentile:
- D50
- Mean:
- 12.05 µm
- Remarks on result:
- other: no more information
- Percentile:
- D90
- Mean:
- 21.73 µm
- Remarks on result:
- other: no more information
- Remarks on result:
- other: No data
- Conclusions:
- The reaction mass of cerium dioxide and zirconium dioxide presents a D50 of 12.05 µm.
- Executive summary:
The particle size distribution of the reaction mass of cerium dioxide and zirconium dioxide was measured in accordance with the laser diffraction method using the granulometer Coulter LS-13320. Such a method is referenced in internationally recognised guidelines. The D10, D50 and D90 reported for the tested sample of the reaction mass of cerium dioxide and zirconium dioxide are 0.649 µm, 12.05 µm and 21.73 µm, respectively.
Referenceopen allclose all
The shape of the particles was reported to be "irregular".
Description of key information
Two independent samples of the reaction mass of cerium dioxide and zirconium dioxide present D50 values of 2.557 µm and 12.05 µm. The sample with the highest D50 was confirmed to be a nanoform. No information is however available on the nano-status of the sample with the smallest D50. For particle size distribution of constituent particles of nanoforms, reference can be made to the analytical section of the dossier. Boundaries for this are given in IUCLID Section 1.2 (Composition) as well.
Additional information
Internal company data of reliability 2 according to Klimisch were included on two different sources of the reaction mass (Tirel, 2010/Paradis, 2006 and MEL, 2010) and flagged as key studies. As granulometry is a substance-specific parameter, granulometry values of both constituents are not reported here.
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