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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:
19 October 2011 until 16 November 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Type of distribution:
volumetric distribution
Test material information:
Composition 1
Key result
Percentile:
D50
Mean:
> 100 µm
Remarks on result:
other: MMD was not actually determined, as > 99.9% of the mass fraction of particles were found to have a diameter > 100 µm (100 µm is the maximum inhalation relevant particle size).(migrated from fields under 'Mass median diameter' as D50 percentile. No source
No.:
#1
Size:
> 100 µm
Distribution:
>= 99.9 %
No.:
#2
Size:
< 100 µm
Distribution:
< 0.1 %

 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

10.68g

Mass of test item passed through sieve

0.01g

Proportion of test item <100 µm

<0.1%

 Discussion

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth and are regarded as having a particle size <100µm. The proportion of test item with a particle size in the inhalable range is insignificant, based on the fact that particles in the range <100µm was determined to be below 0.1% in the preliminary screening test. Therefore, the results of the screening test obviated the need to carry out further characterisation of the test item by cascade impactor or similar methods.

Conclusions:
The proportion of test item with a particle size in the inhalable range (i.e. with diameter < 100 µm) has been determined to be less than 0.1 %.
Executive summary:

The purpose of the study was to determine the particle size distribution of test item 2,5-Diaminotoluene via a method equivalent or similar to OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions). With a screening / sieve method the proportion of test item < 100 µm was determined to be < 0.1%.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth and are regarded as having a particle size <100 µm. The proportion of test item with a particle size in the inhalable range is insignificant, based on the fact that particles in the range <100 µm was determined to be below 0.1% in the preliminary screening test. Therefore, the results of the screening test obviated the need to carry out further characterisation of the test item by cascade impactor or similar methods.

Description of key information

The proportion of test item with a particle size in the inhalable range (i.e. with diameter lower than 100 µm) has been determined to be less than 0.1 %.

Additional information

The particle size distribution of test item 2-methyl-p-phenylenediamine was determined via a method equivalent or similar to OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions). With a screening / sieve method the proportion of test item being of inhalable particle size < 100 µm was determined to be < 0.1%.