Polyamide wax

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:

18th August 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviation from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Qualifier:

according to guideline

Guideline:

other: The sample is analysed using the Coulter Laser Diffraction Analyser fitted with a dry powder module. The test was conducted to BS ISO 13320-1: 1999.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

other: powder

Type of distribution:

volumetric distribution

Percentile:

D50

Mean:

49.15 µm

Remarks on result:

other: Average value taken from three runs. Actual range: 49.01 - 49.28 µm(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

No.:

#1

Size:

< 10 µm

Distribution:

7.51 %

The results of the triplicate analysis are presented in the table below. A graphy of volume (%) versus particle diameter (µm) is attached in background material.

	RUN 1	RUN 2	RUN 3	Average
Volume (%)	100.0	100.0	100.0	100.0
Mean (µm)	44.84	44.77	44.75	44.79
Median (µm)	49.28	49.15	49.01	49.15
Mode (µm)	51.12	51.12	51.12	51.12
95% conf. limit	5.25-383	5.19 – 386	5.17 – 388	5.2 – 385
S.D.	2.99	3.0	3.01	3.0
10% of material is <	12.50 µm	12.36 µm	12.34 µm	12.40 µm
25% of material is <	25.09 µm	24.96 µm	24.87 µm	24.97 µm
50% of material is <	49.28 µm	49.15 µm	49.01 µm	49.15 µm
75% of material is <	92.54 µm	92.65 µm	92.49 µm	92.56 µm
90% of material is <	157.4 µm	158.5 µm	159.0 µm	158.3 µm

7.51% by volume of sample was seen to be ≤ 10.00 µm.

Conclusions:

7.51% by volume of sample was seen to be ≤ 10.00 µm.

Executive summary:

The test was conducted to BS ISO 13320 -1: 1999 in order to determine the particle size distribution of EA-3098. The sample was initially observed to determine whether sieving of the material was required. The final sample was then analysed using the Coulter Laser Diffraction Analyser fitted with a dry powder module. Three runs were conducted to ensure repeatability of results.

A summary of the results observed are as follows:

Standard visual observation

Sample observed to be a free flowing, fine, white powder.

Observation at 100x magnification

The particles appear to be sharp edged, irregular shaped crystals. The smallest particle size was approximately 3 µm and the largest size was approximately 126 µm.

Observation at 400x magnification

The sample was observed to be made up of single crystalline particles.

The laser diffraction test conducted to determine the Particle size analysis produced the following results:

Summary of results:

	Average
Volume %	100.0
Mean (µm)	44.79
Median (µm)	49.15
Mode (µm)	51.12
95% Conf. Limit (µm)	5.2 – 385
S.D.	3
10% of material is <	12.40 µm
25% of material is <	24.97 µm
50% of material is <	49.15 µm
75% of material is <	92.56 µm
90% of material is <	158.3 µm

7.51% by volume of sample was seen to be ≤ 10.00 µm

Description of key information

7.51% by volume of sample was seen to be ≤ 10.00 µm.

Additional information

The laser diffraction test conducted to determine the Particle size analysis produced the following results:

Summary of results:

	Average
Volume %	100.0
Mean (µm)	44.79
Median (µm)	49.15
Mode (µm)	51.12
95% Conf. Limit (µm)	5.2 – 385
S.D.	3
10% of material is <	12.40 µm
25% of material is <	24.97 µm
50% of material is <	49.15 µm
75% of material is <	92.56 µm
90% of material is <	158.3 µm

7.51% by volume of sample was seen to be≤ 10.00µm