Registration Dossier
Registration Dossier
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EC number: 619-217-2 | CAS number: 96487-85-3
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08/04/2016 - 17/02/2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 (Particle size analysis by laser diffraction)
- Principles of method if other than guideline:
- According to REACH Regulation (EC) No 1907/2006 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 the relevant Regulation (EC) No 440/2008. The international OECD 110 test guideline ‘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 document ‘Guidance on information requirements and Chemical SafetyAssessment-Chapter R.7a: Endpoint specific guidance’ stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. ECHA’s guidance mentions the Laser scattering/diffraction as a method suitable for particles of all kind and makes reference to ISO 13320:2009.
- 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:
- (17alpha)-3-ethoxy-19-norpregna-3,5-dien-20-yn-17-ol
- EC Number:
- 619-217-2
- Cas Number:
- 96487-85-3
- Molecular formula:
- C22H30O2
- IUPAC Name:
- (17alpha)-3-ethoxy-19-norpregna-3,5-dien-20-yn-17-ol
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: off-white powder
Test item storage: at room temperature
Constituent 1
- Specific details on test material used for the study:
- Relative density: 1.15
Results and discussion
- Mass median aerodynamic diameter:
- 326.202 µm
- Geometric standard deviation:
- >= 1.677 - <= 1.704
- Remarks on result:
- other: Mass median aerodynamic diameter (MMAD) is the mean of 5 measurements.
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 146.565 µm
- St. dev.:
- 3.248
- Remarks on result:
- other: St.dev.= population standard deviation [µm]
- Key result
- Percentile:
- D50
- Mean:
- 304.185 µm
- St. dev.:
- 3.004
- Key result
- Percentile:
- D90
- Mean:
- 523.495 µm
- St. dev.:
- 4.319
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- 0.81 other: % by volume
- No.:
- #2
- Size:
- < 100 µm
- Distribution:
- ca. 7 other: % by volume
Any other information on results incl. tables
Coefficient of variation for D50 is < 3% and for D10 and D90 < 5%; repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320 standard.
Applicant's summary and conclusion
- Conclusions:
- Particle size distribution of the substance: D10= 147 µm, D50= 304 µm and D90= 523 µm. 0.81% by volume is smaller than 10 µm. ca. 7% by volume is smaller than 100 µm. MMAD= 326 µm.
- Executive summary:
The particle size distribution of the substance was determined using laser diffraction analysis (dry powder module) in a GLP study according to ISO 13320 and CIPAC MT 187. Each result is the average of five runs. Particle size distribution of the substance: D10= 147 µm, D50= 304 µm and D90= 523 µm. 0.81% by volume is smaller than 10 µm. ca. 7% by volume is smaller than 100 µm. MMAD= 326 µm.
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