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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:
2006-09-29 to 2007-04-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions). However, lacking detailed documentation. The testing facility indicated that the protocol was followed without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Remarks:
The testing facility indicated that the protocol was followed without deviation.
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Type of distribution:
counted distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): VRT-753136 hcl
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: white powder
- Analytical purity: 99.4% w/w by High Performance Liquid Chromatography (HPLC)
- Impurities (identity and concentrations): individual unknown components were detected at 0.03 area%; isopropanol (residual solvent) at 300 ppm
- Composition of test material, percentage of components: not applicable
- Isomers composition: not applicable
- Purity test date: 2006-05-25
- Lot/batch No.: 25515
- Expiration date of the lot/batch: May 2008
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other: no data

Results and discussion

Particle size
Percentile:
D50
Mean:
> 160 - < 320 µm
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:
320 - 600 µm
Distribution:
10 %
No.:
#2
Size:
160 - 320 µm
Distribution:
69.1 %
No.:
#3
Size:
60 - 160 µm
Distribution:
19.8 %
No.:
#4
Size:
30 - 60 µm
Distribution:
1 %
No.:
#5
Size:
10.4 - 30 µm
Distribution:
0.1 %
No.:
#6
Size:
0.5 - 10.4 µm
Distribution:
0 %

Any other information on results incl. tables

 

Table 1. Sieve analysis results

Particle size (um)

Test 1

Test 2

Mean

>400

0.3

0.2

0.3

400 - 125

9.5

8.3

8.9

125 - 75

38.9

24.6

31.8

75 - 30

46.9

58.3

52.6

30 - 10

4.4

8.8

6.6

<10

0.0

0.0

0.0

 

Table 2. Image analysis results

Particle size (um)

Test 1

Test 2

Test 3

Test 4

Test 5

Test 6

Mean

320 - 600

0

0

0

30.4

0

29.7

10

160 - 320

73.5

75.4

81.5

47.6

79

57.5

69.1

60.0 - 160

24.9

23.5

17

21.1

20.1

12.1

19.8

30 - 60

1.4

0.9

1.4

0.8

0.8

0.6

1

10.4 - 30

0.1

0.2

0.2

0.1

0.2

0.1

0.1

0.5 - 10.4

0

0

0

0

0

0

0

 

 The observed shape of the test substance was a mixture of rectangular, long and thin particles.

 

Applicant's summary and conclusion

Conclusions:
The results indicated that 0% w/w of the test substance was smaller than 10 um. The majority of the particles were of length greater than 60 um.
Executive summary:

Not applicable