Registration Dossier
Registration Dossier
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EC number: 292-282-9 | CAS number: 90583-79-2
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25.10.2017 - 24-11-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- consilab Gesellschaft für Anlagensicherheit mbH, Industriepark Höchst, G830/G840, 65926 Frankfurt am Main (Germany)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- L-Threonine, N-coco acyl derivs., monosodium salts
- Cas Number:
- 90583-79-2
- Molecular formula:
- n/a
- IUPAC Name:
- L-Threonine, N-coco acyl derivs., monosodium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ajinomoto Co., Inc., 15-1, Kyobashi 1-chome, Chuo-ku, Tokyo, 104-8315, Japan
- Expiration date of the lot/batch: 03.10.2019
- Purity test date: 15.11.2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
Results and discussion
- Mass median aerodynamic diameter:
- 114 µm
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 4.5 µm
- Remarks on result:
- other: only median diameter reported
- Key result
- Percentile:
- D50
- Mean:
- 114 µm
- Remarks on result:
- other: only median diameter reported
- Key result
- Percentile:
- D90
- Mean:
- 1 098 µm
- Remarks on result:
- other: only median diameter reported
Applicant's summary and conclusion
- Conclusions:
- The median particle size D50 was determined to be 114 µm.
- Executive summary:
The particle size distribution of the test item was investigated in a study conducted according to ISO 13320 (Particle size analysis - Laser diffraction methods), OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius), and EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution) via laser diffraction. The median particle size D50 was determined to be 233 µm. The test item was found to consist of a coarse fraction with a particle size >2000 µm of 45.2 % and a fine fraction with a particle size of <2000 µm of 54.8 %.
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