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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:
Analysis start date 2017-03-28. Analysis end date 2017-04-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
other: ISO 4497:1983 Metallic powders -- Determination of particle size by dry sieving
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
ISO 13320-1:1999
Type of method:
sieving
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 170105

ISO 4497:1983
- Particle size distribution determined by dry sieving
- Treatment of test material prior to testing: Analysis on "as received" basis

ISO 13320-1:1999
- Particle size distribution by laser diffraction method
- Treatment of test material prior to laser diffraction (test 2): Particles >500 µm were sieved off before testing due to the capactity of the equipment

Evaluation: WINDOW 5.8.4., FREE Stabil. 1
- Reference measurement: 03-28 13:38:01
- Contamination: 0.00 %
Trigger condition: PQC no focus, opt 0.1
- Time base: 100.00 ms
- Start: c.opt >= 1 %
- Valid: always
- Stop: 5s C.opt <= 0.7 % or 99s real time

Product: Fe-pulver R4
- Density: 1.00 g/cm3
- Shape factor: 1.00
- Copt = 10.23 %

Dispesing method : 50 %, 1.5 mm vibricontrol, 6 %, 10
- Cascade: 0
- Pressure: 3.03 bar, vaccum: 123.00 mbar
- Revolution: 0.00 %
- Doser: VIBRI, feed rate: 50.00 %
Mass median aerodynamic diameter:
62.39 µm
Percentile:
D10
Mean:
4.12 µm
Remarks on result:
other: Result from laser diffraction
Key result
Percentile:
D50
Mean:
62.39 µm
Remarks on result:
other: Result from laser diffraction
Percentile:
D90
Mean:
183.97 µm
Remarks on result:
other: Result from laser diffraction
Percentile:
other: 10.57 %
Mean:
< 4.4 µm
Remarks on result:
other: Result from laser diffraction
Percentile:
other: 10.40 %
Mean:
< 4.4 µm
Remarks on result:
other: Particles > 500 µm were sieved off before laser diffraction, equating to 1.6 % of the particles. Therefore, this result represents the the particle size of the initial sample without sieving.
Percentile:
other: 19.06 %
Mean:
< 10 µm
Remarks on result:
other: Result from laser diffraction
Percentile:
other: 18.76 %
Mean:
< 10 µm
Remarks on result:
other: Particles > 500 µm were sieved off before laser diffraction, equating to 1.6 % of the particles. Therefore, this result represents the the particle size of the initial sample without sieving.
Percentile:
other: 67.12 %
Mean:
< 102 µm
Remarks on result:
other: Result from laser diffraction
Percentile:
other: 66.05 %
Mean:
< 102 µm
Remarks on result:
other: Particles > 500 µm were sieved off before laser diffraction, equating to 1.6 % of the particles. Therefore, this result represents the the particle size of the initial sample without sieving.
No.:
#1
Size:
> 500 µm
Distribution:
1.6 %
Remarks on result:
other: Result from dry sieving
No.:
#2
Size:
> 212 - <= 500 µm
Distribution:
14.8 %
Remarks on result:
other: Result from dry sieving
No.:
#3
Size:
> 150 - <= 212 µm
Distribution:
14.8 %
Remarks on result:
other: Result from dry sieving
No.:
#4
Size:
> 106 - <= 150 µm
Distribution:
12.7 %
Remarks on result:
other: Result from dry sieving
No.:
#5
Size:
> 75 - <= 106 µm
Distribution:
11 %
Remarks on result:
other: Result from dry sieving
No.:
#6
Size:
> 45 - <= 75 µm
Distribution:
11.1 %
Remarks on result:
other: Result from dry sieving
No.:
#7
Size:
< 45 µm
Distribution:
34 %
Remarks on result:
other:
Remarks:
Result from dry sieving
Conclusions:
The particle size distribution of the test item was assessed in accordance with ISO 4497:1983 ans ISO 13320-1:1999.  Dry sieving of the sample determined that 1.6 % of the particles were > 500 µm. Laser diffraction determined the mass median diameter was to be 62.39 µm.  With regards to the inhalation potential, laser diffraction determined that 66.05 % of the particles are smaller than 102 µm, 18.76 % are smaller than 10 µmn and 10.40 % are smaller than 4.40 µm.
Endpoint:
particle size distribution (granulometry)
Remarks:
CS SWeRF
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
DATE SAMPLES RECEIVED: 23.10.17 DATE SAMPLES ANALYSED: 25.10.17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: Powder samples are analysed by laser diffraction
Version / remarks:
Powder samples are analysed by laser diffraction using the internal method SOP-017 “Particle Size Distribution by Laser Diffraction”. The technique for laser diffraction analysis is adopted from ISO 13320:2009 “Particle size analysis – Laser diffraction methods”.
Deviations:
not applicable
GLP compliance:
not specified
Type of method:
Laser scattering/diffraction
Type of particle tested:
other: Portions of sieved samples are finely ground to create samples of uniform particle size
Type of distribution:
other: Quantification of any crystalline silica detected in the samples is carried out using an in-house method based on reference standards, drift correction and a calibration for calculating unknown concentrations.
Key result
Percentile:
other: SWeRF Petrit T Lot 17100300
Mean:
ca. 0 other: SWeRF Cryst. Silica (%)
Remarks on result:
other: Calculation of SWeRF from a Particle Size Distribution
Remarks:
The probability of a particle reaching the alveoli region of the lung is a function of its aerodynamic size (Dae) and the probability specified in the EN481 standard1. The principle behind SWeRF combines the particle size (determined by laser diffraction) and the probability factor, integrated across the complete particle size distribution. It is important to recognise that the EN481 probability is based on aerodynamic size as opposed to the spherical equivalent diameter measured by laser diffraction techniques A size weighting is then applied based on the probability function given in EN481 and expressed as a SWeRF percentage of the bulk. The methodology employed for the calculation of SWeRF is derived from “SWeRF – A Method for Estimating the Relevant Fine Fraction in Bulk Materials for Classification and Labelling Purposes
Key result
Percentile:
other: SWeRF Petrit T Lot 17100406
Mean:
ca. 0.1 other: SWeRF Cryst. Silica (%)
Remarks on result:
other: Calculation of SWeRF from a Particle Size Distribution
Remarks:
The probability of a particle reaching the alveoli region of the lung is a function of its aerodynamic size (Dae) and the probability specified in the EN481 standard1. The principle behind SWeRF combines the particle size (determined by laser diffraction) and the probability factor, integrated across the complete particle size distribution. It is important to recognise that the EN481 probability is based on aerodynamic size as opposed to the spherical equivalent diameter measured by laser diffraction techniques A size weighting is then applied based on the probability function given in EN481 and expressed as a SWeRF percentage of the bulk. The methodology employed for the calculation of SWeRF is derived from “SWeRF – A Method for Estimating the Relevant Fine Fraction in Bulk Materials for Classification and Labelling Purposes
Key result
Percentile:
other: SWeRF Petrit T Lot 17100411
Mean:
ca. 0.1 other: SWeRF Cryst. Silica (%)
Remarks on result:
other: Calculation of SWeRF from a Particle Size Distribution
Remarks:
The probability of a particle reaching the alveoli region of the lung is a function of its aerodynamic size (Dae) and the probability specified in the EN481 standard1. The principle behind SWeRF combines the particle size (determined by laser diffraction) and the probability factor, integrated across the complete particle size distribution. It is important to recognise that the EN481 probability is based on aerodynamic size as opposed to the spherical equivalent diameter measured by laser diffraction techniques A size weighting is then applied based on the probability function given in EN481 and expressed as a SWeRF percentage of the bulk. The methodology employed for the calculation of SWeRF is derived from “SWeRF – A Method for Estimating the Relevant Fine Fraction in Bulk Materials for Classification and Labelling Purposes
Key result
Percentile:
other: SWeRF Petrit T Lot 17100300
Mean:
ca. 2.7 other: SWeRF Bulk Powder (%)
Remarks on result:
other: Calculation of SWeRF from a Particle Size Distribution
Remarks:
The probability of a particle reaching the alveoli region of the lung is a function of its aerodynamic size (Dae) and the probability specified in the EN481 standard1. The principle behind SWeRF combines the particle size (determined by laser diffraction) and the probability factor, integrated across the complete particle size distribution. It is important to recognise that the EN481 probability is based on aerodynamic size as opposed to the spherical equivalent diameter measured by laser diffraction techniques A size weighting is then applied based on the probability function given in EN481 and expressed as a SWeRF percentage of the bulk. The methodology employed for the calculation of SWeRF is derived from “SWeRF – A Method for Estimating the Relevant Fine Fraction in Bulk Materials for Classification and Labelling Purposes
Key result
Percentile:
other: SWeRF Petrit T Lot 17100406
Mean:
ca. 3.2 other: SWeRF Bulk Powder (%)
Remarks on result:
other: Calculation of SWeRF from a Particle Size Distribution
Remarks:
The probability of a particle reaching the alveoli region of the lung is a function of its aerodynamic size (Dae) and the probability specified in the EN481 standard1. The principle behind SWeRF combines the particle size (determined by laser diffraction) and the probability factor, integrated across the complete particle size distribution. It is important to recognise that the EN481 probability is based on aerodynamic size as opposed to the spherical equivalent diameter measured by laser diffraction techniques A size weighting is then applied based on the probability function given in EN481 and expressed as a SWeRF percentage of the bulk. The methodology employed for the calculation of SWeRF is derived from “SWeRF – A Method for Estimating the Relevant Fine Fraction in Bulk Materials for Classification and Labelling Purposes
Key result
Percentile:
other: SWeRF Petrit T Lot 17100411
Mean:
ca. 2.9 other: SWeRF Bulk Powder (%)
Remarks on result:
other: Calculation of SWeRF from a Particle Size Distribution
Remarks:
Calculation of SWeRF from a Particle Size Distribution

Please see attached for the Result Summary: This contains graphs that can't be added in IUCLID  

Conclusions:
In accordance with the CLP Regulation, industrial minerals producers have conducted a Review and Hazard Assessment of the health effects of respirable crystalline silica and have jointly determined it best and appropriate to classify crystalline silica (fine fraction) (quartz (fine fraction) and cristobalite (fine fraction)) as STOT RE 1 for the silicosis hazard. This is because particles of crystalline silica (fine fraction) may become airborne during handling and use in the workplace, creating respirable crystalline silica (RCS).
STOT refers to Specific Target Organ Toxicity. RE refers to “Repeated Exposure”. Based upon scientific evidence, it is generally necessary to inhale significant quantities of RCS in an occupational setting for prolonged and repeated periods of time before any possible long-term health effect may occur.
This classification applies to the fine fraction of quartz and cristobalite only, because it is scientifically demonstrated that it is only this fraction of crystalline silica, when made airborne, which may cause health effects. It is also in compliance with the CLP Regulation which allows consideration of the physical form(s) or physical state(s) of substance or mixture.
As a consequence of this classification, mixtures and substances containing crystalline silica (fine fraction), whether in the form of an identified impurity, additive or individual constituent, are classified as:
STOT RE 1, if the crystalline silica (fine fraction) concentration is equal to, or greater than 10%;
STOT RE 2, if the crystalline silica (fine fraction) concentration is between 1 and 10%.
If the crystalline silica (fine fraction) content in mixtures and substances is below 1%, no classification is required.

Therefore, no classification for this substance is required
Executive summary:

 

Crystalline Silica* Content (bulk)

 

SWeRF

 

Ref

 

SampleDescription

 

R.I

Density (g/cm3)

 

Quartz(%)

 

Cristobalite(%)

Bulk Powder(%)

Cryst.Silica (%)

1

Petrit T Lot17100300

1.97

2.81

1.4

0.2

2.7

0.0

2

Petrit T Lot17100406

1.97

2.81

2.4

0.2

3.2

0.1

3

Petrit T Lot17100411

1.97

2.81

1.8

0.2

2.9

0.1

Description of key information

The particle size distribution of the test item was assessed in accordance with ISO 4497:1983 ans ISO 13320-1:1999.  Dry sieving of the sample determined that 1.6 % of the particles were > 500 µm.  Laser diffraction determined the mass median diameter was to be 62.39 µm.  With regards to the inhalation potential, laser diffraction determined that 66.05 % of the particles are smaller than 102 µm, 18.76 % are smaller than 10 µmn and 10.40 % are smaller than 4.40 µm.  

Additional information

No additional information.