4-O-β-D-galactopyranosyl-D-glucitol

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:

2020

Report date:

2020

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 59.4

Deviations:

no

GLP compliance:

yes

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Test material

Test material information

Constituent 1

Reference substance name:

4-O-β-D-galactopyranosyl-D-glucitol

EC Number:

209-566-5

EC Name:

4-O-β-D-galactopyranosyl-D-glucitol

Cas Number:

585-86-4

Molecular formula:

C12H24O11

IUPAC Name:

4-O-beta-D-galactopyranosyl-D-glucitol

Specific details on test material used for the study:

DETAILS OF TEST MATERIAL
- Purity:100%
- Physical Description: White powdery solid
- pH: 5.1
- Stability: Test substance was expected to be stable for the duration of testing.
- Expiration Date: June 29, 2024
- Test substance was stored at room temperature; Testing was carried out on the test substance as received.

Results and discussion

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

> 850 µm

Distribution:

>= 1.3 - <= 2.3 %

Remarks on result:

other: average: 1.8%; %RSD: 25.7

Particle size distribution at different passages 2

No.:

#2

Size:

>= 500 - <= 850 µm

Distribution:

>= 34.2 - <= 43 %

Remarks on result:

other: average: 38.6%; %RSD: 11.3

Particle size distribution at different passages 3

No.:

#3

Size:

>= 250 - <= 500 µm

Distribution:

>= 48.6 - <= 55.4 %

Remarks on result:

other: average: 52.0%; % RSD: 6.6

Particle size distribution at different passages 4

No.:

#4

Size:

< 250 µm

Distribution:

>= 5.6 - <= 9 %

Remarks on result:

other: average: 7.3%; %RSD: 23.2

Any other information on results incl. tables

Results of Precision: % Retained:

Preparation	Mesh Size
	850 µm	500 µm	250 µm	pan
1	2.2	44.2	47.2	5.4
2	1.7	39.4	52.0	6.9
3	1.3	32.0	56.8	10.0
4	2.3	38.1	51.4	7.4
5	1.4	39.1	52.8	6.9
Average	1.8	38.6	52.0	7.3
% RSD	25.7	11.3	6.6	23.2

Applicant's summary and conclusion

Conclusions:

Precision (repeatability) was evaluated by five replicate measurements. The average percent of particles larger than 850 µm is 1.8%. The average percent of particles in the range of 850 µm - 500 µm is 38.6%. The average percent of particles in the range of 500 µm -250 µm is 52.0%. The average percent of particles smaller than 250 µm is 7.3%.

Executive summary:

The particle size of the test substance was determined according to CIPAC MT-59.4. A known weight of the test substance was passed through three sieves with successively smaller mesh sizes. Specific mesh sizes were selected such that the first sieve allowed most or all of the material to pass through; the second sieve allowed some of the material through while blocking some. The smallest sieve was small enough to block most or all of the material. The exact mesh sieve size numbers used were 20, 35, and 60. Sieve openings were 850 µm, 500 µm, and 250 µm, respectively. Each sieve was individually weighed and recorded.

The sieves were stacked from largest mesh (top) to smallest (bottom). A pan capable of holding and recovering material passing through the bottom sieve was placed beneath the smallest sieve. For each replicate, approximately 50 grams of test substance was weighed and placed on the largest sieve. Soft aggregates were broken up by gentle brushing, ensuring that no hard particles were crushed. Each sieve was covered and manually agitated for 5 minutes until no test material or only an insignificant amount passed through the sieve. After this requirement was met for each sieve in the series, individual sieves and pan were weighed with the retained sample and the first receiver pan and the final weights recorded. Five replicate test substance measurements were used to calculate the assay results.

Precision (repeatability) was evaluated by five replicate measurements. The average percent of particles larger than 850 µm is 1.8%. The average percent of particles in the range of 850 µm - 500 µm is 38.6%. The average percent of particles in the range of 500 µm -250 µm is 52.0%. The average percent of particles smaller than 250 µm is 7.3%.