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Physical & Chemical properties

Particle size distribution (Granulometry)

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
The particle size distribution of calcium carbonate (amorphous form) has been determined.
GLP compliance:
no
Type of method:
sedimentation (gravitational settling)
Type of distribution:
volumetric distribution
Percentile:
D50
Mean:
1.494 µm
Remarks on result:
other: Std dev 1.425(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Percentile:
other: 95.0%
Mean:
< 2.414 µm
Remarks on result:
other: N/A
Percentile:
other: 84.0%
Mean:
< 1.977 µm
Remarks on result:
other: N/A
Percentile:
other: 50.0%
Mean:
< 1.494 µm
Remarks on result:
other: N/A
Percentile:
other: 16.0%
Mean:
< 1.127 µm
Remarks on result:
other: N/A
Percentile:
other: 5.0%
Mean:
< 0.908 µm
Remarks on result:
other: N/A
Conclusions:
The particle size distribution data indicates that 95% of calcium carbonate (amorphous form) particles have a diameter of <2.414 µm and therefore can be considered to be potentially inhalable.
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
The particle size distribution of calcium carbonate (aragonite form) has been determined.
GLP compliance:
no
Type of method:
sedimentation (gravitational settling)
Type of distribution:
volumetric distribution
Percentile:
D50
Mean:
0.419 µm
Remarks on result:
other: Std dev 2.136(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Percentile:
other: 95.0%
Mean:
< 2.849 µm
Remarks on result:
other: N/A
Percentile:
other: 84.0%
Mean:
< 0.89 µm
Remarks on result:
other: N/A
Percentile:
other: 50.0%
Mean:
< 0.419 µm
Remarks on result:
other: N/A
Percentile:
other: 16.0%
Mean:
< 0.258 µm
Remarks on result:
other: N/A
Percentile:
other: 5.0%
Mean:
< 0.205 µm
Remarks on result:
other: N/A
Conclusions:
The particle size distribution data indicates that 95% of calcium carbonate (aragonite form) particles have a diameter of <2.849 µm and therefore can be considered to be potentially inhalable.
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
The particle size distribution of calcium carbonate (bulk form) has been determined.
GLP compliance:
no
Type of method:
other: Two separate methods were used - laser diffraction and sedimentation
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
Bulk CaCO3
Percentile:
D50
Mean:
< 1.8 µm
Remarks on result:
other: Determined with a Sedigraph 5100
Percentile:
D50
Mean:
< 2.6 µm
Remarks on result:
other: Determined with a Sympatec HELOS
Percentile:
other: 57%
Mean:
< 2 µm
Remarks on result:
other: Determined with a Sedigraph 5100
Percentile:
other: 38%
Mean:
< 2 µm
Remarks on result:
other: Determined with a Sympatec HELOS
Conclusions:
The particle size distribution data indicates that the d50% of calcium carbonate (bulk form) particles is <1.8 µm and therefore can be considered to be potentially inhalable.

Description of key information

Bulk calcium carbonate is potentially inhalable based on the particle size distribution of commercial grades.

Additional information