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EC number: 213-126-8 | CAS number: 925-83-7
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 July 2018 - 5 September 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- relative density
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 August 2018 - 19 October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.3 (Relative Density)
- Version / remarks:
- 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 109 (Density of Liquids and Solids)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7300 (Density / Relative Density / Bulk Density)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- air comparison pycnometer (for solids)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was dried in a desiccator under vacuum using silica gel as the drying agent at 20.7 ± 0.8°C protected from light for 50 hours. - Dynamic viscosity of test material:
- not applicable (substance is a solid)
- Key result
- Type:
- relative density
- Density:
- 1.26 other: dimensionless
- Temp.:
- 20 °C
- Remarks on result:
- other: D 20 /4
- Key result
- Type:
- density
- Density:
- 1.26 g/cm³
- Temp.:
- 20 °C
- Conclusions:
- The relative density D20/4 of the substance was determined to be 1.26.
Experiment 1: 1.263 g/cm3
Experiment 2: 1.262 g/cm3
The individual measurements were obtained with an accuracy of < 0.02 g/cm3.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 (Particle size analysis by laser diffraction)
- Version / remarks:
- Handbook K, 2007
- Deviations:
- no
- Principles of method if other than guideline:
- According to REACH Article 13(3) tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. No particle size distribution test method is laid down in regulation (EC) No 440/2008. OECD 110 TG ‘Particle Size Distribution/FibreLength and Diameter Distributions’ dates from 1981 and describes two methods in detail; both methods have restrictions and are not applicable to the entire size range. ECHA’s Guidance on information requirements and Chemical Safety Assessment-Chapter R.7a stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. The guidance mentions Laser scattering/diffraction as a method for particles of all kinds and makes reference to ISO 13320:2009.
According to Guidance document EUR 20268 (2002), the laser diffraction technique is applicable to particles of respirable and inhalable size. The MMAD can be calculated when the density is known. - GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- Sebacohydrazide
- EC Number:
- 213-126-8
- EC Name:
- Sebacohydrazide
- Cas Number:
- 925-83-7
- Molecular formula:
- C10H22N4O2
- IUPAC Name:
- sebacohydrazide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test item name (as stated in report): SDH
Test item storage: at room temperature protected from light
Constituent 1
- Specific details on test material used for the study:
- Relative density: 1.26
Test item was tested as received.
Results and discussion
- Mass median aerodynamic diameter:
- 4.78 µm
- Geometric standard deviation:
- >= 2.125 - <= 2.16
- Remarks on result:
- other: The MMAD above is the average of 5 runs. GSD was calculated from d50/d15.78. The min. and max. GSD values of 5 runs are provided above. The St.dev. in the table below is the population standard deviation [µm].
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 1.41 µm
- St. dev.:
- 0.015
- Remarks on result:
- other: std. dev. of the population
- Key result
- Percentile:
- D50
- Mean:
- 4.26 µm
- St. dev.:
- 0.031
- Remarks on result:
- other: std. dev. of the population
- Key result
- Percentile:
- D90
- Mean:
- 10.7 µm
- St. dev.:
- 0.178
- Remarks on result:
- other: std. dev. of the population
Particle size distribution at different passages
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- 88.01 %
- Remarks on result:
- other: volume of sample
Any other information on results incl. tables
Conclusion of visual and microscopic evaluation:
- visual observation: very fine, white crystalline powder with clusters
- 100 x magnification: irregular shaped crystals; smallest individual particle size was approximately 3 μm and the largest individual size was approximately 13 μm
- 400 x magnification: single crystalline particles
Laser Diffraction Particle Size Analysis:
The coefficient of variation for d50 is less than 3 %; d10 and d90 are less than 5 %.
Thus repeatability of the characteristic particles in the size distribution is within the acceptable limits as per the ISO 13320-1 test standard.
Applicant's summary and conclusion
- Conclusions:
- The particle size distribution of the substance was determined as follows: D10 = 1.41 µm, D50 = 4.26 µm and D90 = 10.7 µm.
88.01% of the sample volume was determined to be smaller than 10 µm. The MMAD was calculated to be 4.78 µm.
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