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EC number: 914-172-8 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Apparatus: Laser particle size: Malvern Mastersizer 2000. Module DRY: SCIROCCO 2000S.
Procedure - special measurement conditions: DRY module can measure particle sizes between 200 µm and 2mm. - GLP compliance:
- not specified
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- No.:
- #1
- Size:
- <= 100 µm
- Distribution:
- < 3 %
- Conclusions:
- The results of a particle size distribution study show that the reaction mass of calcium bis(dihydrogenorthophosphate) and calcium hydrogenorthophosphate has less than 3% of the particles with a diameter of <100µm and therefore cannot be considered to be an inhalation risk. This study is considered to satisfy the guideline requirements for this endpoint and is therefore acceptable for use as a key study.
Reference
The following table lists the statistical data of the five measurements made:
Statistics (%) |
Measure No. 10-0742-4-1 |
Measure No. 10-0742-4-2 |
Measure No. 10-0742-4-3 |
Measure No. 10-0742-4-4 |
Measure No. 10-0742-4-5 |
D[4, 3 µm] |
913,687 |
901,310 |
947,057 |
915,273 |
928,460 |
D[3, 2 µm] |
512,497 |
538,301 |
557,160 |
520,910 |
550,321 |
%<0,1 µm |
0,00 |
0,00 |
0,00 |
0,00 |
0,00 |
%<1 µm |
0,00 |
0,00 |
0,00 |
0,00 |
0,00 |
%<10 µm |
0,00 |
0,00 |
0,00 |
0,00 |
0,00 |
%<100 µm |
2,21 |
1,93 |
1,85 |
2,13 |
1,84 |
%<1000 µm |
59,69 |
61,71 |
56,37 |
59,74 |
58,55 |
d(0,1) µm |
360,953 |
393,895 |
400,895 |
376,231 |
395,560 |
d(0,2) µm |
560,842 |
562,556 |
596,053 |
568,031 |
581,450 |
d(0,5) µm |
892,343 |
873,467 |
929,899 |
893,177 |
906,478 |
d(0,8) µm |
1282,688 |
1253,028 |
1318,750 |
1279,524 |
1293,129 |
d(0,9) µm |
1495,764 |
1466,891 |
1525,932 |
1491,936 |
1503,889 |
Description of key information
The results of a particle size distribution study show that the reaction mass of calcium bis(dihydrogenorthophosphate) and calcium hydrogenorthophosphate has less than 3% of the particles with a diameter of <100µm and therefore cannot be considered to be an inhalation risk.
Additional information
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