Registration Dossier

Diss Factsheets

Physical & Chemical properties

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:
2018
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

Constituent 1
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
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 %.