Magnesium fluoride

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:

20-Sept-2016 - 14-Nov-2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Materion / lot 662599-1
- Expiration date of the lot/batch: 31-Jul 2017
- Purity test date: 18- Jan-2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: RT, away from moisture
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: low solubility
- Reactivity of the test substance with the solvent/vehicle: not expected

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: 25 mg of test item were applied topically onto the tissue surface (after wetting by 25 uL sterile DPBS) by spoon, for 60 minutes.
- Final preparation of a solid: Before the measurement the test item was sieved through a 2000um sieve. The coarse fraction was 45 wt.% and the fine fraction 55 wt.%

Mass median aerodynamic diameter:

873 µm

Percentile:

D10

Mean:

491.5 µm

St. dev.:

6.22

Key result

Percentile:

D50

Mean:

872.7 µm

St. dev.:

6.43

Percentile:

D90

Mean:

1 440.3 µm

St. dev.:

10.82

Two test series of 3 measuremnts each were performed with the fine fraction of the test item. Table 1 and 2 below show the results of the both test series.

Test series 1
D10	495.9 um
D50	868.2 um
D90	1432.6 um
Test series 2
D10	487.1 um
D50	877.3 um
D90	1447.9 um

Conclusions:

The test item Magnesium Fluoride has a median particle size D50 = 873 um, which was determined by laser diffraction measurement.

Executive summary:

Two test series of 3 measurements each were performed with the tes item. Before measurement the sample was sieved through 2000 um sieve. 55 wt % of the sample contained the fine fraction. From the measured diffraction pattern the particle size distribution was calculated. From the cumulative distribution following characteristic values were derived:

D10 = 491.5 um. 10 Vol.-% of the particles have smaller diameter

D50 = 872.7 um. 50 Vol.-% of the particles have smaller diameter

D90 = 1440.3 um. 90 Vol.-% of the particles have smaller diameter

The study was considered reliable without restrictions since it was conducted according the current international guidelines and in compliance with GLP.

Description of key information

The test item Magnesium Fluoride has a median particle size D50 = 873 um, which was determined by laser diffraction measurement. The particle size ranged from 80um to 2000um.