L-Valine, N-(methoxycarbonyl)-3-methyl-

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:

3 December 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test carried out in compliance with method given in "Particle Size Distribution Fibre Length and Diameter Distribution", June 1996 Europmen Commission technical guidance document

Qualifier:

according to guideline

Guideline:

other: Cascade Impactor Method, as per Particle Size Distribution, Fibre Length and Diameter Distribution, June 1996 European Commission Technical Guidance Document.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Remarks on result:

not determinable because of methodological limitations

Remarks:

Proportion of inhalable particles (< 10 μm in size) was not sufficiently high to allow for accurate assessment of MMAD.

No.:

#1

Size:

ca. 100 µm

Distribution:

ca. 69.6 %

No.:

#2

Size:

ca. 10 µm

Distribution:

ca. 18.6 %

Representative sampling was ensured by rolling the sample container for approximately 10 minutes and sampling from the top, middle and bottom prior to definitive testing.

The results of the sieving procedure (screening) are shown at the table below:

Sieve aperture size (μm)	100
Mass of test material transferred to sieve (g)	19.52
Mass of test material passed through the sieve (g)	13.58
% of test material less than sieve aperture size	69.6

The cumulative amounts found for the individual particle size cut-points for all three determinations are shown in the table below:

Cup No	Particle size cut-points (μm)	Cumulative amount of test material - A (%)	Cumulative amount of test material B (%)	Cumulative amount of test material C (%)
2	10	17.8	17.7	20.2
3	5	4.49	4.45	4.96
4	2.5	1.98	1.86	2.13
5	1.25	1.17	1.07	1.26
Filter	0.625	0.723	0.629	0.749

Conclusions:

Proportion of test material having a particle size less than 10 μm was 18.6%.
Proportion of test material having a particle size less than 100 μm was 69.6%.
Results indicate that the proportion by mass of particles which, if inhaled, can be expected to deposit in the respiratory tract in man is 18.6%. However, they were to few to allow for accurate assessment of mass median aerodynamic diametre.

Executive summary:

Particle size distribution of BMS 214702-01 was determined using a cascade impactor. The proportion of test material having a particle size less than 10 μm, and thus was inhalable, was 18.6%. Most of these particles would not make it to the alveolar region. They would deposit higher in the respiratory tract.

Description of key information

Particle size distribution of BMS 214702-01 was determined using a cascade impactor. The proportion of test material having a particle size less than 10 μm, and thus was inhalable, was 18.6%. Most of these particles would not make it to the alveolar region. They would deposit higher in the respiratory tract.

Additional information

Proportion of test material having a particle size less than 10 μm was 18.6%.

Proportion of test material having a particle size less than 100 μm was 69.6%.

Results indicate that the proportion by mass of particles which, if inhaled, can be expected to deposit in the respiratory tract in man is 18.6%. However, there were too few data points to allow for accurate assessment of mass median aerodynamic diametre.