2H-3-Benzazepin-2-one, 3-[2-(1,3-dioxolan-2-yl)ethyl]-1,3-dihydro-7,8-dimethoxy-

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The determination was carried out using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guidance Document EUR 20268

Version / remarks:

Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

Deviations:

no

Principles of method if other than guideline:

Sieve Screening : An aliquot (approximately 10 to 20 g) of test item was added to a 100 μm sieve fitted onto a receiver pan of known mass. A lid was then secured onto the sieve and the assembled apparatus placed on the sieve shaker for a period of approximately 30 minutes. The sieve shaker table, on which the sieve rests, had an inclination of 4.5°, a nominal rotation speed of 2.5 rpm and vibrated at approximately 300 oscillations/min with an approximately 4 mm amplitude. Following the shaking period, the mass of the receiver pan and collected test item was recorded and the percentage of test item with a particle size less than 100 μm calculated.
Second part : Cascade Impactor : An aliquot (approximately 3 g) of test item was introduced by aid of an anti-static weighing boat into the artificial throat of the cascade impactor. During the determinations, air was drawn through the cascade impactor by a vacuum pump at a flow rate of approximately 60 L/ min for approximately 30 seconds. The air flow enters the impactor through a throat and inlet tube and then accelerates through the multiple stages. At each stage one or more nozzles direct the particle-laden airstream into a collection cup.

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Test material

Test material information

Constituent 1

Reference substance name:

617-898-0

EC Number:

617-898-0

Cas Number:

866462-52-4

Molecular formula:

C17 H21 N O5

IUPAC Name:

617-898-0

Test material form:

solid: particulate/powder

Details on test material:

Off white powder

Specific details on test material used for the study:

Batch 18108859

Sieving Apparatus (Screening Test) :
Instrument : Inclyno Sieve Shaker, Model No 1
Sieve : 100 μm stainless steel mesh (ISO 3310-1: 2000)

Cascade Impactor
Instrument : MSP Corporation, Marple Miller 160 Cascade Impactor
Particle size range : nominally 0.3 to 10 μm

Results and discussion

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

ca. 52.2 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

ca. 3.65 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

ca. 0.6 %

Any other information on results incl. tables

Results of the sieving procedure are :

Mass of test item transferred to sieve : 12.56 g

Mass of test item passed through sieve : 6.55 g

Percentage of test item less than 100 μm : 52.2 %

(See complete report TN47PW particule size distribution attached)

Applicant's summary and conclusion

Conclusions:

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes then sampled from the top, middle and bottom.
Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.
Percentage of test item with an inhalable particle size <100 μm : 52.2%
Percentage of test item with a thoracic particle size <10.0 μm : 3.35%
Percentage of test item with a respirable particle size <5.5 μm : 0.60%