2-isopropyl-N,2,3-trimethylbutyramide

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2017 - November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

agglomerate

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

2-isopropyl-N,2,3-trimethylbutyramide

EC Number:

256-974-4

EC Name:

2-isopropyl-N,2,3-trimethylbutyramide

Cas Number:

51115-67-4

Molecular formula:

C10H21NO

IUPAC Name:

2-isopropyl-N,2,3-trimethylbutyramide

Test material form:

solid

Specific details on test material used for the study:

Batch number: 80100005
Expiration date: 13 October 2018
Purity: 99.8%
Stored at Room temperature (nominally 15 to 25C), dark
Physical state/appearance: White solid

Results and discussion

Mass median aerodynamic diameter:

174 µm

Particle size

Particle size 1

Percentile:

D10

Mean:

79 µm

Remarks on result:

other: No standard deviation

Particle size 2

Key result

Percentile:

D50

Mean:

174 µm

Remarks on result:

other: No standard deviation

Particle size 3

Percentile:

D90

Mean:

398 µm

Remarks on result:

other: No standard deviation

Any other information on results incl. tables

Table 1. Overall mean values for the 10%, 50% and 90% quantile particle size results for WS-23

Parameter	Size (µm)
d(0.1)	79
d(0.5)	174
d(0.9)	398

d(0.1): diameter at which 10% of the particle distribution is smaller and 90% is larger.

d(0.5): diameter at which 50% of the particle distribution is smaller and 50% is larger. This value is also known as the Mass Median Diameter (MMD).

d(0.9): diameter at which 90% of the particle distribution is smaller and 10% is larger.

Applicant's summary and conclusion

Conclusions:

Following determination of particle size distribution of WS-23, 10% of the distribution had a diameter of ≤79 µm, 50% had a diameter of ≤174 µm and 90% had a diameter of ≤398 µm. The Median Diameter (MMD) is determined to be 174 µm.

Executive summary:

The size distribution of particles present in the WS-23 was assessed using particle size apparatus based on laser diffraction. Following determination of particle size distribution of WS-23, 10% of the distribution had a diameter of ≤79 µm, 50% had a diameter of ≤174 µm and 90% had a diameter of ≤398 µm. The Mass Median Diameter (MMD) is determined to be 174 µm.