2-amino-2-methylpropane-1,3-diol

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May - September 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Key result

Percentile:

D50

Remarks on result:

other: Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

No.:

#1

Size:

< 100 µm

Distribution:

16.4 %

Remarks on result:

other: Inhalable particle size, method: sieve (screening test)

No.:

#2

Size:

< 10 µm

Distribution:

<= 2.01 %

Remarks on result:

other: Thoracic particle size, method: cascade impactor (definitive test)

No.:

#3

Size:

< 5.5 µm

Distribution:

<= 0.76 %

Remarks on result:

other: Respirable particle size, method: cascade impactor (definitive test)

Screening test: the results of the sieving procedure are shown in the following table:

Measurement	Result
Mass of test item transferred tosieve	15.02g
Mass of test item passed throughsieve	2.47g
Percentage of test item less than 100µm	16.4%

Definitive test (cascade impactor method):

The cumulative amounts of test item found in the three determinations for the individual particle size cut-points are shown in the following table:

 

 

ParticleSizeCutPoints(µm)	Cumulative Mass(g)			Cumulative Percentage(%)
	Determination1	Determination2	Determination3	Determination1	Determination2	Determination3
<10.0	0.0155	0.0332	0.0601	0.52	1.12	2.01
<5.5	0.0012	0.0088	0.0226	0.04	0.30	0.76
<2.4	0.0003	0.0038	0.0128	0.01	0.13	0.43
<1.61	0.0003	0.0021	0.0075	0.01	0.07	0.25
<0.307	0.0003	0.0003	0.0009	0.01	0.01	0.03

 

Mean cumulative percentage with a particle size less than 10.0μm:≤2.01

Mean cumulative percentage with a particle size less than 5.5μm:≤0.76

Executive summary:

See summary endpoint.

Description of key information

particle size < 100 µm: 16.4%
particle size < 10.0 µm: <= 2.01%
particle size < 5.5 µm: <= 0.76 %

Additional information

The study was conducted according to the requirements of OECD Guideline 110. Particle size < 100 µm: inhalable fraction (screening test, sieve method); particle size < 10 µm: thoracic fraction and particle size < 5.5 µm: respirable fraction (both: definitive test, cascade impactor method).