Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
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:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
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:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Version / remarks:
1996
Deviations:
no
Guideline:
other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction
Version / remarks:
2009
Deviations:
no
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder
Details on test material:
- Storage conditions: Room Temperature (20 ± 5 °C)
- Expiry date: 12/16/19

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D50
Mean:
20.2 µm
St. dev.:
0.19
Percentile:
D10
Mean:
2.4 µm
St. dev.:
0.02
Percentile:
D90
Mean:
97.5 µm
St. dev.:
1.27

Applicant's summary and conclusion

Conclusions:
The study was performed in accordance with generally accepted scientific standards and described in sufficient detail and therefore reliability of Klimisch 1 has been assigned. Result: D50 = 20.2 µm
Executive summary:

The particle size distribution of the test item 3,3-bis(4-hydroxy-5-isopropyl-o-tolyl)phthalide was determined by laser light scattering, according to OECD Guideline 110 (and ISO 13320 and OPPTS 830.7520). The test material has a median particle size of D50 = 20.2 µm.