Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-09-23 2011-10-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: this study was conducted in a testing lab holding a GLP statement

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The test item was visually assessed
GLP compliance:
yes
Type of distribution:
other: visual assessement

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):LCE11051 acetalization product between glucose and C12/18(even numbered)alcohol
- Substance type: UVCB
- Physical state: solid pellets
- Analytical purity:100%
- Lot/batch No.:T12825

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
ca. 5 mm
Remarks on result:
other: based on visual assessment(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Percentile:
other: 100%
Mean:
ca. 5 mm
Remarks on result:
other: based on avisual assessment
Particle size distribution at different passages
Remarks on result:
other: this not possible to determined as the results are based on a visual assessment

Any other information on results incl. tables

as the particle size distribution is based on a visual assessment, it is not possible to fill out the fiels "particle size at differnt passages"

Applicant's summary and conclusion

Conclusions:
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 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. no finer fraction (for example dust) was observed in the sample.