Registration Dossier
Registration Dossier
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EC number: 922-178-7 | 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:
- 2011-11-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: even if the study is only based on a visually assessment, we stated ist is reliable as it is scientifically justifiable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
- Principles of method if other than guideline:
- this study is based on a visual assessment of the particle size distribution
- GLP compliance:
- yes
- Remarks:
- no certificate
- Type of distribution:
- other: visual assessment
Test material
- Reference substance name:
- LCE11049
- IUPAC Name:
- LCE11049
- Details on test material:
- - Name of test material (as cited in study report): LCE11049- distilled acetalization products between glucose and C12/18 alcoholà
- Substance type: UVCB
- Physical state: solid
- Analytical purity:100%
- Lot/batch No.:TO4211
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- other: 100%
- Mean:
- > 4 - <= 5 mm
- Remarks on result:
- other: visual assessment show s only diameter approximately 4 to 5 mm. No dust or finer fraction was observed
Applicant's summary and conclusion
- Conclusions:
- the test item was observed to be cream coloured, opaque disk shaped pellets, with one flat side and one convex side. the test item was of a uniform particle size distribution , with individual pellets having a diameter of approximately 4 to 5 mm . no finer fraction (for example dust ) was observed in the sample.
- Executive summary:
The visual assessment was performed in preference of the sieving procedure referenced in OECD guideline 110, 12 may 1981; however the observations confirmed the absence of any fraction with a particle size below 100µm, defined as the "inhalable fraction" in the european commission technical guidance document "particle size distribution, fibre length an,d diameter distribution"(june 1996), which satisfies the requirement of OECD guideline 110, 12 may 1981.
The test item was visually assessed to be a cream coloured, opaque disk shaped pellets, with one flat side and one convex side. the test item was of a uniform particle size distribution, with individual pellets having a diameter of approximately 4 to 5 mm. no finer fraction (for example dust) was observed in the sample.
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