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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10/5/2016-10/5/2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Justification for type of information:
Experimental test result performed using standard methods
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The particle size distribution was determined with the help of Rotap sieve shaker. For this method, calibrated sieves were stacked with the coarsest opening sieve at the top of the stack and finest opening sieve at the bottom. 10 gm test item was weighed and put in the coarsest opening sieve placed at the top of the stack, covered with the lid. The stack was fitted in sieve shaker and was shaken for 10 minutes. The material was emptied from the above coarsest sieve into a pre-weighed petridishes. A soft bristle brush was used to remove all the particles. The quantity obtained from the 1st sieves was weighed, and transferred to original apparatus. The above procedure was repeated for each sieve. Weight obtained from each sieve was then divided by the weight of the test item taken and percentage of each sieve was calculated.
GLP compliance:
no
Type of method:
sieving
Type of distribution:
mass based distribution
Key result
Percentile:
D50
Remarks on result:
not measured/tested
No.:
#1
Size:
150 µm
Distribution:
19.47 %
No.:
#2
Size:
106 µm
Distribution:
60.38 %
No.:
#3
Size:
75 µm
Distribution:
7.67 %
No.:
#4
Size:
53 µm
Distribution:
4.78 %
No.:
#5
Size:
25 µm
Distribution:
3.98 %

Sieve sizes(in microns)

Percentage distribution (%) of test item

150 microns

19.47%

106 microns

60.38%

75 microns

7.67%

53 microns

4.78%

25 microns

3.98%

10 microns

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There was some loss of particulate matter that remained adhered within the fine sieve even after proper brushing

Conclusions:
The particle size distribution of test item 2-butyl-6-(butylamino)-1H-benz [de]isoquinoline-1,3(2H)- dione (CAS No. 19125-99-6 ) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 25 micron.
Executive summary:

The particle size distribution of test item 2-butyl-6-(butylamino)-1H-benz [de]isoquinoline-1,3(2H)-dione (CAS No. 19125-99-6 ) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 25 micron.

Description of key information

The particle size distribution of test item 2-butyl-6-(butylamino)-1H-benz [de]isoquinoline-1,3(2H)-dione(CAS No. 19125-99-6) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 25 micron. This indicates that the particles are not of inhalable size.

Additional information

The particle size distribution of test item2-butyl-6-(butylamino)-1H-benz [de]isoquinoline-1,3(2H)-dione(CAS No. 19125-99-6) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 25 micron. This indicates that the particles are not of inhalable size.