Diamminediisocyanatozinc

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:

1993-03-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

other: Schering Agrochemical standard Quality Control (QC) method of testing.

Deviations:

not specified

GLP compliance:

not specified

Other quality assurance:

other: The measurement of particle size distribution was made according to a Schering Agrochemical standard Quality Control (QC) method of testing.

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

other: not stated

Mass median aerodynamic diameter:

>= 14.32 - <= 18.84 µm

Remarks on result:

other: D(50%)

Remarks:

D(50%) µm = 18.49

Percentile:

D99

Mean:

>= 50.2 - <= 64.6 µm

Remarks on result:

other: 99.7& are <64.6µm, 98.2% are below 50.2%

Remarks:

batch 3

Key result

Percentile:

other: 100%

Mean:

< 84.3 µm

Remarks on result:

other: consistent over three passages

Percentile:

D50

Mean:

14.32 µm

Remarks on result:

other: batch 1

Percentile:

D50

Mean:

18.84 µm

Remarks on result:

other: batch 2

Percentile:

D50

Mean:

18.5 µm

Remarks on result:

other: batch 3

Percentile:

other: 99.7%

Mean:

< 50.2 µm

Remarks on result:

other: batch 1

Percentile:

other: 5.8%

Mean:

< 12.8 µm

Remarks on result:

other: batch 1

Percentile:

other: 98.7%

Mean:

< 50.2 µm

Remarks on result:

other: batch 2

Percentile:

other: 10.4%

Mean:

< 5.8 µm

Remarks on result:

other: batch 2

Percentile:

other: 98.2%

Mean:

< 50.2 µm

Remarks on result:

other: batch 3

Percentile:

other: 11%

Mean:

< 5 µm

Remarks on result:

other: batch 3

Conclusions:

The test was performed scientifically reasonable on three different bathces and was documented sufficiently. Hence, the results can be considered sufficiently reliable. Based on these results, 100% of the particles have the potential to be inhaled. Of these, approx. 99% may reach the thoracic region (according to ECHA's former guidance R7.C, 50µm) or approx. 25% (10µm, R7.C of July 2015), and of those of them,which may reach the alveoles, are approx. 50% or approx. 10%, dependent on the guidance.

Executive summary:

The particle size of three different batches of the test item was performed by a Malvern Instruments Mastersizer laser particle sizer.

The maxima in the binodal distribution are at approximately 7 and 18 µm with mean particle sizes being calculated as 14.3, 18.8 and 18. 5 µm for batches 1,2,3, respectively.

Each of the samples of the test item show a significant spread of particle sizes, with an upper size limit being between 64 and 84 µm. At least 20% by weight of each of the samples are less than 10 µm in size.

Description of key information

The particle size of three different batches of the test item was performed by a Malvern Instruments Mastersizer laser particle sizer.

The maxima in the binodal distribution are at approximately 7 and 18 µm with mean particle sizes being calculated as 14.3, 18.8 and 18. 5 µm for batches 1,2,3, respectively.

Each of the samples of the test item show a significant spread of particle sizes, with an upper size limit being between 64 and 84 µm. At least 20% by weight of each of the samples are less than 10 µm in size.

Additional information

Based on these results, 100% of the particles have the potential to be inhaled. Of these, approx. 99% may reach the thoracic region (according to ECHA's former guidance R7.C, 50µm) or approx. 25% (10µm, R7.C of July 2015), and of those of them,which may reach the alveoles, are approx. 50% or approx 10%, dependent on the guidance.