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Physical & Chemical properties

Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-06-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: ISO13320-1: Particle Size Analysis - Laser Diffraction Methods
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed, 2009-10-29
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Remarks on result:
not measured/tested
Percentile:
D50
Mean:
246.6 µm
St. dev.:
4.77
Percentile:
D10
Mean:
102.2 µm
St. dev.:
3.97
Percentile:
D90
Mean:
466.2 µm
St. dev.:
6.49
Conclusions:
The median particle size L50 of the test items deduced from the particle size distributions is 246.6 µm.
The particle size L10 of the test items deduced from the particle size distributions is 102.2 µm.
The particle size L90 of the test items deduced from the particle size distributions is 466.2 µm.
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-06 to 2010-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
no data for "purity test date"
Qualifier:
according to guideline
Guideline:
DIN 55992-1 (Determination of a parameter for the dust formation of pigments and extenders - Part 1: Rotation method)
Deviations:
yes
Remarks:
modified Heubach method
Principles of method if other than guideline:
The Heubach dust meter is modified in a way that a seven stage cascade impactor is connected to the system. This involves an additional air fed of 20 L/min via the coarse dust separator needed to supply the cascade impactor with 40 L/min air current as specified in the manufacturer’s specificcations.
The calculation report: Grewe, T (2010)
The Multiple-Path Particle Dosimetry Model (MPPD, v2.0; CIIT, 2006) was used to predict this fractional deposition behaviour for workers.
The model algorithms calculate the deposition (and clearance) of mono-disperse and polydisperse aerosols in the respiratory tract for particles ranging from ultra-fine (0.01 microns) to coarse (20 microns) sizes. Within each airway, deposition is calculated using theoretically derived efficiencies for deposition by diffusion, sedimentation and impaction within the airway or airway bifurcation. Filtration of aerosols by the head is determined using empirical efficiency functions (for further information see "attached background material").
GLP compliance:
not specified
Type of method:
cascade impaction
Remarks:
modified heubach method
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
26.1 µm
Geometric standard deviation:
2.04
Remarks on result:
not measured/tested

Dustiness (airborne fraction): total: 9.29 mg/g.

In the original study report by DMT, a calculation of the mass median diameter was not conducted. Since the deposited fractions were provided for each of the cascade impactor stages, it was possible to fit a mono modal lognormal distribution to the data by standard non-linear regression procedure. As a result, the MMAD and GSD are calculable and reported (MMAD = 26.10 µm, GSD = 2.04). As the cascade impactor already takes aerodynamic characteristics of the particles into account, the reported mass median diameter can be interpreted as the mass median aerodynamic diameter.

This figure and the corresponding GSD were used as distribution parameters for the MPPD model enabling an estimation of deposited dust fractions in the human respiratory tract: These fractions were estimated as follows:

Head (ET): 51.5 %

Tracheobronchial (TB): 0.2%

Pulmonary (PU): 0.2%

Conclusions:
Sodium sulfite, anhydrous

Total Dustiness (airborne fraction): 9.29 mg/g (DMT)

Mass median aerodynamic diamaters (mono-modal distribution) of airborne fraction: MMAD = 26.10

Geometric standard deviation of MMAD: GSD = 2.04

Fractional deposition in human respiratory tract (MPPD model, based on calculated MMAD):
Head (ET): 51.5 %
Tracheobronchial (TB): 0.2 %
Pulmonary (PU): 0.2 %

Description of key information

The particle size of a representative sodium sulfite sample was determined to be: 
D50 = 246.6 µm
D10 = 102.2 µm
D90 = 466.2 µm
Dustiness and MMAD (GSD) of airborne material:
Dustiness: 9.29 mg/g; MMAD (GSD): 26.10 µm (2.04)
For more details see discussion and technical dossier.

Additional information

The particle size distribution of the test item was determined by laser diffraction (light scattering) according to OECD guideline 110.

The test item was tested as received and was analysed with the Master-Sizer 2000 (Version 5.12G) of Malvern Instruments with a dry powder feeder; measuring range was 0.02 to 2000 µm.

In addition to the physical particle size, the dustiness, i.e. the tendency of the materials to become airborne, has been determined with a representative sample using the modified Heubach method (in accordance withDIN 55992 -1:2006, Determination of a parameter for the dust formation of pigments and extenders – Part 1: Rotation method). In this modified method - in addition to the dustiness - the mass median aerodynamic diameter of the airborne particles has been determined using cascade impactor data. Further, the Multiple-Path Particle Dosimetry Model (MPPD, v2.0; CIIT, 2006) was used to predict fractional deposition behaviour of these particles in the human respiratory tract.