N-(tri(hydroxymethyl)methyl)glycine

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 Jan 2018 - 17 Jan 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)

GLP compliance:

yes

Type of method:

Laser scattering/diffraction

Type of particle tested:

agglomerate

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

N-(tri(hydroxymethyl)methyl)glycine

EC Number:

227-193-6

EC Name:

N-(tri(hydroxymethyl)methyl)glycine

Cas Number:

5704-04-1

Molecular formula:

C6H13NO5

IUPAC Name:

2-{[1,3-dihydroxy-2-(hydroxymethyl)propan-2-yl]amino}acetic acid

Test material form:

solid: particulate/powder

Results and discussion

Mass median aerodynamic diameter:

ca. 54.07 µm

Geometric standard deviation:

> 2.117 - < 2.135

Particle size

Particle size 1

Key result

Percentile:

D10

Mean:

< 20.774 µm

St. dev.:

0.673

Particle size 2

Key result

Percentile:

D50

Mean:

< 52.767 µm

St. dev.:

0.649

Particle size 3

Key result

Percentile:

D90

Mean:

< 134.433 µm

St. dev.:

1.945

Any other information on results incl. tables

Using the identified parameters, the particle size was analyzed over the range 0.02 μm to 2000 μm.

The results of the formal analysis are presented in Table 9:1. In addition, a graph of volume (%) versus Particle Diameter (μm), and full particle size distribution, is provided in Graph 9.A (Average of 5 runs).

Table 9:1 : Full Test Results

	RUN 1	RUN 2	RUN 3	RUN 4	RUN 5	Average**
Volume weighted mean	67.869	68.299	69.728	68.871	69.802	68.914
Median	53.225	53.304	53.305	52.208	51.763	52.767
Mode	53.01	52.318	52.293	51.052	50.098	51.774
MMAD *	54.539	54.62	54.622	53.498	53.041	54.07
d10 - 10 % of material is <	20.271	21.75	21.39	20.517	19.989	20.774
d50 - 50 % of material is <	53.225	53.304	53.305	52.208	51.763	52.767
d90 - 90 % of material is <	136.403	131.419	134.034	133.738	136.737	134.433

All results are in µm

* Mass median aerodynamic diameter

** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

1.26 % by volume of sample was seen to be < 10.00 µm.

Table 9:2 : Standard Deviation results

Run No.	1	2	3	4	5	STDVP	% STDVP
d10 - 10 % of material is <	20.271	21.75	21.39	20.517	19.989	0.673	3.2
d50 - 50 % of material is <	53.225	53.304	53.305	52.208	51.763	0.649	1.2
d90 - 90 % of material is <	136.403	131.419	134.034	133.738	136.737	1.945	1.4
d15.78 - 15.78 % of material is <	24.925	26.29	25.947	24.999	24.45	0.686	2.7
GSD	2.135	2.028	2.054	2.088	2.117	0.04	1.9
MMAD	54.539	54.62	54.622	53.498	53.041	0.665	1.2

GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78) STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:

The particle size was analysed over the range 0.02 µm to 2000 µm using a DPM Module. The average result is calculated from the entirety of data captured in each of the five runs. The averages are: d10 - 10 % of material is <20.774, d50 - 50 % of material is <52.767, and d90 - 90 % of material is <134.433.

Executive summary:

 The particle size was analysed over the range 0.02 µm to 2000 µm using a DPM Module. The average result is calculated from the entirety of data captured in each of the five runs. The averages are: d10 - 10 % of material is <20.774, d50 - 50 % of material is <52.767, and d90 - 90 % of material is <134.433.