Registration Dossier

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:
2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data provided, but no report or supporting information on test procedures provided

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Principles of method if other than guideline:
Details of the guideline followed to determine the experimental result are not provided.
GLP compliance:
not specified
Type of method:
Laser scattering/diffraction

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
> 200 µm
Remarks on result:
other: 0-1% for fine unground hydrate; 2-5% for coarse unground hydrate
No.:
#2
Size:
< 100 µm
Remarks on result:
other: 88% for fine unground hydrate; 52-61% for coarse unground hydrate
No.:
#3
Size:
< 2 µm
Remarks on result:
other: 1.3-2% for fine unground hydrate; 1% for coarse unground hydrate

Any other information on results incl. tables

Samples of each type evaluated in duplicate

Applicant's summary and conclusion

Conclusions:
The proportion of test material having an inhalable particle size less than 100 µm was determined to be 88% for the fine unground hydrate and 52-61% for the coarse unground hydrate. The proportion of test material having a respirable particle size less than 2 µm was determined to be 1.3-2% for the fine unground hydrate and 1% for the coarse unground hydrate.