TOMILAC 214

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 4 March 2009 and 29 May 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Recently conducted GLP compliant study using the most recent test methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of distribution:

counted distribution

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:

Results and discussion

Particle size

Percentile:

D50

Mean:

> 100 µm

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Any other information on results incl. tables

Screening test (sieve method)

The results of the sieving procedure are shown in the following table:

Sieve aperture size (pm)	100
Mass of test material transferred to sieve (g)	10.49
Mass of test material passed through sieve (g)	1.63
Test material less than sieve aperture size (%)	15.5

Definitive test (cascade impactor method)

Determination 1

The results of the cascade impactor method are shown in the following table:

Determination 1 Cup Number Particle Size Range Collected (pm) Cup Masses (g) Pre-sampling Post-sampling Difference 1 >10.0 86.1141 89.0132 2.8991 2 5.5-10.0 85.3924 85.3953 0.0029 3 2.4 - 5.5 85.9109 85.9131 0.0022 4 1.61 -2.4 85.6276 85.6286 0.0010 5 0.307-1.61 85.7889 85.7896 0.0007 Filter <0.307 0.1197 0.1193 -0.0004[*]

 

Amount of test material found in artificial throat: 0.02 g.

Total amount of test material recovered from impactor cups, filter and artificial throat: 2.9259 g.

The cumulative amounts found for the individual particle size cut-points (pm) are shown in the following table:

Determination 1 Cup Number Particle Size Cut-points(μm) Cumulative Mass of Test Material (g) Cumulative Amount of Test Material (%) 2 10.0 0.0068 0.232 3 5.5 0.0039 0.133 4 2.4 0.0017 5.81 x10* 5 1.61 0.0007 2.39 x10"^2 Filter 0.307 <0.0001 0.000

[*]Negative value obtained for weight difference not included in calculations

Determination 2

The results of the cascade impactor method are shown in the following table:

Determination 2 Cup Number Particle Size Range Collected (μm) Cup Masses (g) Pre-sampling Post-sampling Difference 1 >10.0 86.1229 88.4535 2.3306 2 5.5-10.0 85.4472 85.4501 0.0029 3 2.4-5.5 85.9237 85.9229 -0.0008[*] 4 1.61-2.4 85.6422 85.6414 -0.0008* 5 0.307-1.61 85.7996 85.7997 0.0001 Filter <0.307 0.1179 0.1180 0.0001

 

Amount of test material found in artificial throat: 0.74 g.

Total amount of test material recovered from impactor cups, filter and artificial throat: 3.0737g.

The cumulative amounts found for the individual particle size cut-points (μm) are shown in the following table:

Determination 2 Cup Number Particle Size Cut-points(μm) Cumulative Mass of Test Material (g) Cumulative Amount of Test Material (%) 2 10.0 0.0031 0.101 3 5.5 0.0002 6.51 x 10^-3 4 2.4 0.0002 6.51 x 10^-3 5 1.61 0.0002 6.51 x10^-3 Filter 0.307 0.0001 3.25 x10^-3

[*]Negative value obtained for weight difference not included in calculations

Determination 3

The results of the cascade impactor method are shown in the following table:

Determination 3 Cup Number Particle Size Range Collected (μm) Cup Masses (g) Pre-sampling Post-sampling Difference 1 >10.0 86.1149 88.4434 2.3285 2 5.5-10.0 85.4364 85.4390 0.0026 3 2.4 - 5.5 85.9116 85.9129 0.0013 4 1.61 -2.4 85.6252 85.6260 0.0008 5 0.307- 1.61 85.7886 85.7897 0.0011 Filter <0.307 0.1205 0.1205 0.0000

 

Amount of test material found in artificial throat: 0.72 g.

Total amount of test material recovered from impactor cups, filter and artificial throat: 3.0543

The cumulative amounts found for the individual particle size cut-points (μm) are shown in the following table:

Determination 3 Cup Number Particle Size Cut-points (μm) Cumulative Mass of Test Material (g) Cumulative Amount of Test Material (%) 2 10.0 0.0058 0.190 3 5.5 0.0032 0.105 4 2.4 0.0019 6.22 x10^-2 5 1.61 0.0011 3.60 x 10^-2 Filter 0.307 0.0000 0.000

The overall cumulative amounts of test material with a particle size less than 10.0 μm (%) from Determinations 1 to 3 are shown in the following table:

Determination	Cumulative Amount of Test Material Less Than 10.0 μm(%)	Mean Cumulative Amount of Test Material Less Than 10.0 μm (%)
1	0.232	0.174
2	0.101
3	0.190

 

The overall cumulative amounts of test material with a particle size less than 5.5 μm (%) from Determinations 1 to 3 are shown in the following table:

Determination	Cumulative Amount of Test Materia! Less Than 5.5 μm (%)	Mean Cumulative Amount of Test Material Less Than 5.5 μm (%)
1	0.133	8.15 x10^-2
2	6.51 x10^-3
3	0.105

Too few particles were of a size less than 10.0 pm to allow accurate assessment of mass median aerodynamic diameter.

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

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.

Applicant's summary and conclusion

Conclusions:

The mass median diameter of particles of the substance is >100 micrometers. The substance is considered not to present a respiration hazard.

Executive summary:

The particle size distribition has been assessed using the sieve method and cascade impactor according to OECD method 110 in compliance with GLP. The test material was tested initially to determine the quantity of substance passing through a 100 μm sieve followed by a definitive test in a cascade impactor designed to be representative of an artificial throat followed by 5 stages with decreasing aerodynamic diameter. The mass of substance contained in the articial throat, each of the collection cups of the 5 stages and a final filter are measured to determine the quantity of substance which can be considered respirable and the likely deposition in lung tissues. The mass median diameter is considered to be >100 μm and considered to not represent a respiration hazard.