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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Oct-11 Dec 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Principles of method if other than guideline:
The method used is based on a procedure designed to be compatible with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110, 12 May 1981.
GLP compliance:
yes
Type of method:
sieving
Type of particle tested:
other: not specified
Type of distribution:
other: mass % < 100 um
Key result
Percentile:
other: 1.48%
Mean:
< 100 µm
Remarks on result:
other: St deviation is not available
No.:
#1
Size:
< 100 µm
Distribution:
1.48 %

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 1.48 %.

The test item has been considered to be essentially non-inhalable

Details on results

Screening test (sieve method)

The results of the sieving procedure are shown in the following table:

 

 

Measurement

Result

Mass of test item transferred to sieve

11.50 g

Mass of test item passed through sieve

0.17 g

Proportion of test item <100 µm

1.48 %

 

 

Conclusions:
The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 1.48 %. The test item has been considered to be essentially non-inhalable.
Executive summary:

The method used is based on a procedure designed to be compatible with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110, 12 May 1981.

  

Conclusion

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 1.48 %. The test item has been considered to be essentially non-inhalable.

Description of key information

< 100 µm:  1.48 %

Additional information

The particle size distribution of glycine (CAS 56-4-6) was determined by sieve method. The method used in this GLP study satisfies the requirements of OECD Guidline 110.

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 1.48 %. The test item has been considered to be essentially non-inhalable.