2-methyl-p-phenylenediamine

Particle size distribution (Granulometry)

Link to relevant study record(s)

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of distribution:

volumetric distribution

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%.