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:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Short analysis report, raw data not reported but still considered reliable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The goal of the study was to demonstrate the actual product appearance and establish the existence of the agglomerates.
Particle size (PS) distribution of Aluminum Super Phosphate (AlASP) was measured in water and Methylene Chloride.
GLP compliance:
no
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D50
Mean:
168.488 µm
Remarks on result:
other: In water without sonication
Percentile:
D50
Mean:
151.589 µm
Remarks on result:
other: In water with sonication
Percentile:
D50
Mean:
121.791 µm
Remarks on result:
other: In methylene chloride with sonication

Any other information on results incl. tables

The first measurement was done in water with without sonication. The histogram visibly shows that ca. 40% of AlASP sample is agglomerates with diameters > 200 µm. After sonication, the second measurement histogram clearly changes and the overall particle size is measurably reduced.

A third measurement was done in methylenechloride after sonication. The measurement results revealed similar PS distribution with comparison to the measurements done in water after sonication.

Applicant's summary and conclusion

Conclusions:
The difference in the histograms and the particles size reduction in both solvents proves that the product contain agglomerates.
The large initial particle size and the strong tendency to form agglomerates reduces the possibility of the substance particles dispersing in air and becoming airborne, and thus, minimizes the availability of the substance through the inhalation route.