Registration Dossier
Registration Dossier
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EC number: 445-910-2 | CAS number: 1388152-30-4
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2005 - April 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted using a method which complies with that specified in "Particle Size Distribution, Fibre Lenght and Diameter Distribution" (june 1996 European Commission technical guidance document), which satifies the requirements of OECD Guideline 110. Carries out in accordance with GLP. Study material is well characterized.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- sieving
- Remarks:
- Screening test was carried out with sieving
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- -
- EC Number:
- 445-910-2
- EC Name:
- -
- Cas Number:
- 1388152-30-4
- Molecular formula:
- Hill formula: C24 H32 N2 O7 Si CAS formula: C15 H20 O3 Si . C9 H12 N2 O4
- IUPAC Name:
- (1R,2R)-1,3-Dihydroxy-1-(4-nitrophenyl)propyl-2-ammonium (1R, 5S)-5-(dimethylphenylsilyl)-2-(hydroxymethyl)cyclopent-2-ene-1-carboxylate
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 passages
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- 5.38 %
Any other information on results incl. tables
The results of the sieving procedure are shown in the following table:
| Sieve Aperature Size (um) | 100 |
| Massof test material transferred to sieve (g) | 10.08 |
| Masss of test material passed through sieve (g) | 0.54 |
| Test material less than sieve aperature size (%) | 5.38 |
Applicant's summary and conclusion
- Conclusions:
- The test material is considered to be of a particle size that is essentially non-inhalable
- Executive summary:
The Proportion of the test material having an inhalable particle size less than 100 um is 5.38%. The test material is considered to be of a particle size that is essentially non-inhalable.
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