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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: ISO
Version / remarks:
2591-1, 3310-1
Deviations:
no
Qualifier:
according to
Guideline:
other: SMA
Version / remarks:
721.02, 743.02
Deviations:
no
Qualifier:
according to
Guideline:
other: Draft EUR 20268 EN
Deviations:
no
GLP compliance:
no
Other quality assurance:
other: Internal Management System
Type of method:
other: Light microscopic examination, Sieving and PSD by laser diffraction
Type of particle tested:
primary particle
Percentile:
D10
Mean:
2.63 µm
St. dev.:
0.1
Remarks on result:
other: of the 16.5 wt% < 100 um fraction
Percentile:
D50
Mean:
23.5 µm
St. dev.:
0.5
Remarks on result:
other: of the 16.5 wt% < 100 um fraction
Percentile:
D90
Mean:
82.6 µm
St. dev.:
1.2
Remarks on result:
other: of the 16.5 wt% < 100 um fraction
No.:
#1
Size:
< 100 µm
Distribution:
16.5 %
No.:
#2
Size:
> 100 µm
Distribution:
83.5 %
Conclusions:
The granulometry of 2,2’-[propane-1,3-diylbis(oxy)]bis(3’’,5,5’’-tri-tert-butyl-5’-methyl-1,1’:3’,1’’-terphenyl-2’-ol)was determined in accordance with European Chemicals Agency (ECHA), Guidance on information requirements and chemical safety assessment, Chapter R.7a, Endpoint specific guidance, May 2008.

Light microscopic examination revealed that the product contains many particles < 100 µm. The fraction < 100 µm resulting from sieving on a 100 µm sieve is 16.5%m/m.

From the whole product 4.4 wt% is < 10 µm and 2.7% is < 5 µm.
Executive summary:

The granulometry of 2,2’-[propane-1,3-diylbis(oxy)]bis(3’’,5,5’’-tri-tert-butyl-5’-methyl-1,1’:3’,1’’-terphenyl-2’-ol)was determined in accordance with European Chemicals Agency (ECHA), Guidance on information requirements and chemical safety assessment, Chapter R.7a, Endpoint specific guidance, May 2008.

Light microscopic examination revealed that the product contains many particles < 100 µm. The fraction < 100 µm resulting from sieving on a 100 µm sieve is 16.5%m/m.

From the whole product 4.4 wt% is < 10 µm and 2.7% is < 5 µm.

Description of key information

Light microscopic examination revealed that the product contains many particles < 100 µm. The fraction < 100 µm resulting from sieving on a 100 µm sieve is 16.5%m/m.

From the whole product 4.4 wt% is < 10 µm and 2.7% is < 5 µm.

Additional information