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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
Study period:
24.5.-11.9.2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The determination was carried out using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002 and the results can therefore be thought of as reliable with restriction. A known amount test item was sieved with a mesh of 100 μm and the percentage of test item to pass through the sieve was calculated. According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary if there are virtually no particles with diameters below 100 μm. The study is GLP compliant.
Qualifier:
according to guideline
Guideline:
other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate included in the study report.
Type of method:
sieving
Type of distribution:
mass based distribution
Remarks on result:
other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 2.92%. The test item has been considered to be essentially non-inhalable.
Key result
Remarks on result:
other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 2.92%. The test item has been considered to be essentially non-inhalable.
No.:
#1
Size:
ca. 100 µm
Distribution:
<= 2.92 %
Remarks on result:
other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 2.92%. The test item has been considered to be essentially non-inhalable.
Conclusions:
A screening test consisting of sieving a known amount of test item with a 100 μm mesh concluded that only 2.92 % of the test item passed through the sieve and are inhalable. According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary. The test item is considered to be essentially non-inhalable.
Executive summary:

The proportion of test item having an inhalable particle size of less than 100 μm was determined by a sieve method to be 2.92%. Particle size data was acquired using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002. The test item is considered to be essentially non-inhalable.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24.5.-11.9.2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The determination was carried out using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002 and the results can therefore be thought of as reliable with restriction. A known amount of test item was sieved with a mesh of 100 μm and the percentage of test item to pass through the sieve was calculated. According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary if there are virtually no particles with diameters below 100 μm. The study is GLP compliant.
Qualifier:
according to guideline
Guideline:
other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate included in the study report.
Type of method:
sieving
Type of distribution:
mass based distribution
Remarks on result:
other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.01%. The test item has been considered to be essentially non-inhalable.
Key result
Remarks on result:
other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.01%. The test item has been considered to be essentially non-inhalable.
No.:
#1
Size:
ca. 100 µm
Distribution:
< 1.01 %
Remarks on result:
other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.01%. The test item has been considered to be essentially non-inhalable.
Conclusions:
A screening test consisting of sieving a known amount of test item with a 100 μm mesh concluded that only 1.01 % of the test item passed through the sieve and are inhalable. According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary. The test item is considered to be essentially non-inhalable.
Executive summary:

The proportion of test item having an inhalable particle size of less than 100 μm was determined by a sieve method to be 1.01%. Particle size data was acquired using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002. The test item is considered to be essentially non-inhalable.

Description of key information

Mass based distribution (100 μm sieve): particle size of less than 100 μm: 1.01 - 2.92 % (EC EUR 20268, GLP)

Additional information

A screening test consisting of sieving a known amount of test item with a 100 μm mesh concluded that only 2.92 % of the sodium form test item passed through the sieve and are inhalable. Only 1.01 % of the sodium/hydrogen form test item passed through the sieve and are inhalable.

According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary. The test item is considered to be essentially non-inhalable.