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EC number: 926-197-1 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 September 2015-02 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 13320:2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Deviations:
- no
- 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.
The analysis is conducted initially using a visual microscope and is then undertaken more formally using a Laser Diffraction Particle Size Analyser. - GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- 5-[(S)-4-Carboxy-4-(1,3-dioxo-1,3-dihydro-isoindol-2-yl)-butyrylamino]-2-nitro-benzoic acid
- EC Number:
- 926-197-1
- Cas Number:
- 2561176-48-3
- Molecular formula:
- C20 H15 N3 O9
- IUPAC Name:
- 5-[(S)-4-Carboxy-4-(1,3-dioxo-1,3-dihydro-isoindol-2-yl)-butyrylamino]-2-nitro-benzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name (as cited in study report): P-Glupa-C
- Appearance: yellow powder containing agglomerations and lumps of > 200 µm. It was difficult to break up these lumps.
- Relative density at 20°C: 1.51 (see endpoint 4.4)
-Test material was manually sieved through 250 µm prior to laser diffraction analysis.
Constituent 1
Results and discussion
- Mass median aerodynamic diameter:
- >= 158.725 - <= 161.762 µm
- Geometric standard deviation:
- >= 2.382 - <= 2.393
Particle sizeopen allclose all
- Percentile:
- D10
- Mean:
- 41.646 µm
- St. dev.:
- 0.28
- Percentile:
- D50
- Mean:
- 129.782 µm
- St. dev.:
- 0.933
- Percentile:
- D90
- Mean:
- 270.315 µm
- St. dev.:
- 1.502
Particle size distribution at different passages
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- 1.04 %
Any other information on results incl. tables
Mean MMAD: 159 µm (St.dev.= 1.15 µm)
Mean mode: 166 µm
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 are within the acceptable limits as per the ISO 13320 standard.
The values shown above (including the MMAD) are for the sieved sample only i.e. the fraction of sample which was < 250 µm. Although the sample was sieved through a 250 µm sieve, the laser analysis did observe some particles > 250 µm. This occurs because larger particles can pass through the sieve due to their orientation.
Applicant's summary and conclusion
- Conclusions:
- The particle size distribution of the substance was determined by manual sieve analysis (250 µm) followed by laser diffraction analysis-dry powder module. The study was GLP-compliant and in accordance with ISO 13320 and CIPAC MT 187. The substance fraction < 250 µm was 32.3% by weight. Result of the laser diffraction analysis on the < 250 µm fraction: 1.0% < 10.00 µm, 10% < 41.6 µm, 50% < 130 µm and 90% < 270 µm. The MMAD= 159 µm.
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