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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 01 August 2002 and 17 October 2002.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

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)
Remarks:
Date of inspection: February 28th 2000, Date of signature: April 26th 2000
Type of distribution:
counted distribution

Test material

Constituent 1
Details on test material:
Sponsor's identification :S178207
Description : white powder
Batch number : NBZ 0155/44
Date received : 18 July 2002
Storage conditions :room temperature, in the dark

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
> 0 - < 100 µm
Distribution:
48.1 %
No.:
#1
Size:
> 0 - < 10 µm
Distribution:
36.2 %

Any other information on results incl. tables

 Screening test (sieve method)

The results of the sieving procedure are shown in below.

Sieve Aperture Size (µm)

100

Mass of test material transferred to sieve (g)

10.00

Mass of test material passed through sieve (g)

4.81

Test material less than sieve aperture size (%)

48.1

 


Definitive test (cascade impactor method)

Determination 1

The results of the cascade impactor method are shown below.

Determination 1

Cup Number

ParticleCollected (µm)

Cup Masses (g)

Pre-sampling

Post-sampling

Difference

1

>10

86.8523

86.9256

0.0733

2

5 – 10

86.0138

86.0331

0.0193

3

2.5 – 5

86.4909

86.4962

0.0053

4

1.25 - 2.5

86.1840

86.1868

0.0028

5

0.625 - 1.25

86.3706

86.3721

0.0015

Filter

<0.625

75.6420

75.6623

0.0203

Amount of test material found in artificial throat: 0.0733 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 0.1225 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown below.

Determination 1

Cup Number

Particle Size Cut-points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10

0.0492

40.2

3

5

0.0299

24.4

4

2.5

0.0246

20.1

5

1.25

0.0218

17.8

Filter

0.625

0.0203

16.6

 


Determination 2

The results of the cascade impactor method are shown below.

  Determination 2

Cup Number

ParticleCollected (µm)

Cup Masses (g)

Pre-sampling

Post-sampling

Difference

1

>10

86.8512

86.9618

0.1106

2

5 – 10

86.0143

86.0326

0.0183

3

2.5 – 5

86.4884

86.4943

0.0059

4

1.25 - 2.5

86.1843

86.1875

0.0032

5

0.625 - 1.25

86.3686

86.3703

0.0017

Filter

<0.625

75.6424

75.6611

0.0187

Amount of test material found in artificial throat: 0.1106 g.
Total amount of test material recovered from impactor cups, filter and artificial throat: 0.1584 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown below.

 Determination 2

Cup Number

Particle Size Cut-points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10

0.0478

30.2

3

5

0.0295

18.6

4

2.5

0.0236

14.9

5

1.25

0.0204

12.9

Filter

0.625

0.0187

11.8

 


 Determination 3

The results of the cascade impactor method are shown below.

  Determination 3

Cup Number

ParticleCollected (µm)

Cup Masses (g)

Pre-sampling

Post-sampling

Difference

1

>10

86.8498

86.9514

0.1016

2

5 – 10

86.0144

86.0429

0.0285

3

2.5 – 5

86.4882

86.4958

0.0076

4

1.25 - 2.5

86.1851

86.1889

0.0038

5

0.625 - 1.25

86.3685

86.3703

0.0018

Filter

<0.625

75.6419

75.6630

0.0211

Amount of test material found in artificial throat = 0.1016 g.
Total amount of test material recovered from impactor cups, filter and artificial throat = 0.1644 g.

The cumulative amounts found for the individual particle size cut-points (µm) are shown below.

  Determination 3

Cup Number

Particle Size Cut-points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10

0.0628

38.2

3

5

0.0343

20.9

4

2.5

0.0267

16.2

5

1.25

0.0229

13.9

Filter

0.625

0.0211

12.8

 The overall cumulative amounts of test material with a particle size less than 10 µm (%) from Determinations 1 to 3 are shown ibelow.

Determination

Cumulative Amount of Test Material Less Than 10 µm (%)

Mean Cumulative Amount of Test Material Less Than 10 µm (%)

1

40.2

36.2

2

30.2

3

38.2

Particle size data acquired for the test material are shown below.

Measurement

Method

Result

Proportion of test material having a particle size less than 100 µm

Sieve

48.1%

Proportion of test material having a particle size less than 10 µm

Cascade Impactor

36.2%

Applicant's summary and conclusion

Conclusions:
The results indicate that the proportion by mass of particles which, if inhaled, can be expected to achieve pulmonary deposition is at least 30%. This indicates that there is potential for the test material to be hazardous by inhalation depending on toxicity and use pattern.
Executive summary:

Particle Size Distribution. Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance document 'Particle Size Distribution, Fibre Length and Diameter Distribution' (June 1996), which satisfies the requirements of OECD Guideline 110. The results are shown below.

Measurement

Method

Result

Proportion of test material less than 100 µm

Sieve

48.1%

Proportion of test material less than 10 µm

Cascade Impactor

36.2%

The results indicate that the proportion by mass of particles which, if inhaled, can be expected to achieve pulmonary deposition is at least 30%. This indicates that there is potential for the test material to be inhaled.