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EC number: 417-560-0 | CAS number: 67881-98-5
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 November 2008 to 19 March 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was conducted in accordance with the relevant international Guideline (CIPAC MT58.2). The study report provided all relevant information confirming the validity of the test and the description of the methodology was sufficient for the test to be wholly reproduceable.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 58.2
- Deviations:
- yes
- Remarks:
- See Further information on methods.
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Regulation (1999)
- Type of distribution:
- counted distribution
Test material
- Reference substance name:
- -
- EC Number:
- 417-560-0
- EC Name:
- -
- Cas Number:
- 67881-98-5
- Molecular formula:
- C11H22NO6P
- IUPAC Name:
- trimethyl[2-({2-[(2-methylprop-2-enoyl)oxy]ethyl phosphonato}oxy)ethyl]azanium
- Details on test material:
- - Name of test material (as cited in study report): HEMA-PC (2-Methacryloyloxyethyl-2'-(trimethylammoniumethyl) phosphate
- Substance type: Pure Active Substance
- Physical state: Solid
- Analytical purity: 99 % (98-101 %)
- Impurities (identity and concentrations): 0.1 % by area (HPLC)
- Purity test date: 29 September 2008
- Lot/batch No.: SS148076
- Expiration date of the lot/batch: 27 October 2009 (lab default)
- Stability under test conditions: Stable
- Storage condition of test material: Under nitrogen at -20 degrees celsius in the dark.
- Other: N/A
Constituent 1
Results and discussion
Particle size
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 150 µm
- Distribution:
- 1.8 %
- No.:
- #2
- Size:
- >= 150 - < 250 µm
- Distribution:
- 3.4 %
- No.:
- #3
- Size:
- >= 250 - < 355 µm
- Distribution:
- 1 %
- No.:
- #4
- Size:
- >= 355 - < 420 µm
- Distribution:
- 0.7 %
- No.:
- #5
- Size:
- >= 420 - < 500 µm
- Distribution:
- 7 %
- No.:
- #6
- Size:
- >= 500 - < 710 µm
- Distribution:
- 3.8 %
- No.:
- #7
- Size:
- >= 710 - < 850 µm
- Distribution:
- 6.1 %
- No.:
- #8
- Size:
- >= 850 µm
- Distribution:
- 76.1 %
Any other information on results incl. tables
N/A
Applicant's summary and conclusion
- Conclusions:
- Determination of granulometry was conducted successfully according to CIPAC Guideline MT58.2.
76.1 % of the test item was determined to exist in the >850 μm fraction. A full breakdown of the test item granulometry is provided in the particle size distribution section of this study summary. - Executive summary:
Determination of granulometry was conducted successfully according to CIPAC Guideline MT58.2.
76.1 % of the test item was determined to exist in the >850 μm fraction. A full breakdown of the test item granulometry is provided in the particle size distribution section of this study summary.
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