4-benzyloxy-2-nitro-beta-pyrrolidinostyrene

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017/04/19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

-

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

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:

Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-

Cas Number:

99474-22-3

Molecular formula:

C19H20N2O3

IUPAC Name:

Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-

Specific details on test material used for the study:

- Analytical purity: > 98.4%
 - Lot/batch No.: 0159115
 - Expiration date of the lot/batch: 21/02/2018

Results and discussion

Particle size

Particle size 1

Key result

Percentile:

D50

Mean:

ca. 40.4 µm

St. dev.:

2.5

Particle size 2

Percentile:

D10

Mean:

ca. 7.3 µm

St. dev.:

0.2

Particle size 3

Percentile:

D90

Mean:

ca. 222.8 µm

St. dev.:

23.3

Any other information on results incl. tables

Particle Size Distribution

Two test series of 3 measurements each were performed with the test item.

Test series 1:

D10:       7.4 µm

D50:       42.1 µm       (Median diameter)

D90:       239.3 µm

Test series 2:

D10:       7.1 µm

D50:       38.6 µm       (Median diameter)

D90:       206.3 µm

Average

D10:       7.3 µm

D50:       40.4 µm       (Median diameter)

D90:       222.8 µm

Applicant's summary and conclusion

Conclusions:

The test item IMEXINE OBA/50 SEC has a median particle size of D50 = 40 µm, which was determined by laser diffraction measurement.

Executive summary:

The test item IMEXINE OBA/50 SEC has a median particle size of D50 = 40 µm, which was determined by laser diffraction measurement, according to ISO 13320 in GLP-compliant conditions.