4-Bromo-2-fluoro-N-methylbenzamide

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 AUG 2020 to 05 AUG 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction, Handbook K.

Version / remarks:

2007

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

4-Bromo-2-fluoro-N-methylbenzamide

EC Number:

808-257-8

Cas Number:

749927-69-3

Molecular formula:

C8H7BrFNO

IUPAC Name:

4-Bromo-2-fluoro-N-methylbenzamide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot/batch number of test material: FFP-106-200011
- Expiry date: 17 March 2021 (retest date)
- Physical Description: Almost white powder
- Purity: 99.0%
- Purity test date: 21 MAR 2020
- Purity correction factor: no
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under storage conditions: no data
- Stability under test conditions: no data
- Solubility and stability of the test item in the solvent/vehicle: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: not applicable

Results and discussion

Mass median aerodynamic diameter:

216 µm

Geometric standard deviation:

1.869

Particle size

Particle size 1

Key result

Percentile:

D10

Mean:

70.2 µm

St. dev.:

1.06

Particle size 2

Key result

Percentile:

D50

Mean:

162 µm

St. dev.:

1.25

Particle size 3

Key result

Percentile:

D90

Mean:

326 µm

St. dev.:

6.57

Any other information on results incl. tables

In the preliminary test, the substance was concluded to be visually insoluble in the dispersant, thus only dispersability was investigated in the main test.

The test item proved to be homogeneously and well dispersed in Milli-Ro and therefore this solvent was used as the dispersant in the Laser Diffraction Analysis. The particle size distribution of the test item was analysed over the range 0.01 μm to 1400 μm.

The coefficient of variation for d50 is less than 3%, and for d10 and d90 is less than 5%. It can be concluded that the repeatability of the measured particle size distributions is within the acceptable limits.

Applicant's summary and conclusion

Conclusions:

The particle size distribution of the test item was determined by means of Laser Diffraction Analysis using the medium volume (wet) module (MVM).
The D50 of the test item was determined to be 162 μm, the D10 was 70.2 μm and the D90 was 326 μm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 216 μm.