Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

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:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Method B

Deviations:

no

GLP compliance:

no

Other quality assurance:

ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)

Type of method:

microscopic examination

Type of distribution:

mass based distribution

Mass median aerodynamic diameter:

122 µm

Key result

Percentile:

D50

Mean:

122 µm

Remarks on result:

other: Median diameter corresponds to MMAD (Mass Median Aerodynamic Diameter).(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

The sample was first sieved by a 100 µm sieve.

weighted sample: 1,61895 g

weight fraction <100 µm: 0.0008 g

mass fraction <100 µm: 0.05 %

The mass fraction <100 µm was 0.05 %, and was investigated by scanning electron microscopy. The median aspect ratio was 1.39 with 1.33 as standard deviation.

The median diameter of the particle size is given for the fraction <100 µm. The value 122 µm was calculated for cubical and for sherical particles.

Particle Size	Spherical Voume[%]	Cubical Volume[%]
<4 µm (respirable)	0.00	0.00
4 - 10 µm (thoracic)	0.09	0.11
10 - 100 µm (inhalable)	29.63	33.36
>100 µm*)	70.28	66.53
Median (diameter µm)	122.37	120.96

   

*) These Particles belong to the sieve fraction < 100 μm. Particles with an aspect ratio >1 (e.g. long and thin particles) may have a greater mean diameter than the sieve fraction of 100μm.

Conclusions:

The MMAD (Mass Median Aerodynamic Diameter < 100 μm) has a value of 122.37 μm as spherical particles. All particles with a mean diameter less than 100µm have a mass fraction of 0.01 %. 0.0 % of this mass fraction has a mean diameter less than 10 μm.

Executive summary:

According to OECD guideline 110, the particle size distribution of tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate was determined by scanning eletron microscopy method for the sieved fration and presented on the basis of calculated mass fractions referring to the total sample weight. All particles with a mean diameter less than 100µm have a mass fraction of 0.01 %. 0.0 % of this mass fraction has a mean diameter less than 10 μm. The mass mediam diameter is 122.37 µm (spherical volume) and 120.96 µm (cubial volume).

Description of key information

The MMAD (Mass Median Aerodynamic Diameter < 100 μm) has a value of 122.37 μm as spherical particles. Accounting on the total sample weight the fraction <4 µm (respirable) and the fraction 4 -10 µm (thoracic) was 0 % . The fraction of 10 -100 µm (inhalable) was 0.01% .

Additional information

According to OECD guideline 110, the particle size distribution of tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate was determined by scanning eletron microscopy method for the sieved fration and presented on the basis of calculated mass fractions referring to the total sample weight. All particles with a mean diameter less than 100µm have a mass fraction of 0.01 %. 0.0 % of this mass fraction has a mean diameter less than 10 μm. The mass mediam diameter is 122.37 µm (spherical volume) and 120.96 µm (cubial volume).