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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:
16 August 2010-16 August 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction

Test material

Constituent 1
Chemical structure
Reference substance name:
Lysine hydrochloride
EC Number:
211-519-9
EC Name:
Lysine hydrochloride
Cas Number:
657-27-2
Molecular formula:
C6H14N2O2.ClH
IUPAC Name:
lysine hydrochloride
Details on test material:
- Identification: L-Lysine Monohydrochloride
- Molecular formula: C6H14N2O2HCl
- Molecular weight: 182.65
- CAS Number: 657-27-2
- Description: Beige powder with lumps (determined at NOTOX B.V.)
- Batch: 0148
- Purity: 99.72%
- Impurities (identity and concentrations): -
- Composition of test material, percentage of components: -
- Isomers composition: -
- Purity test date: -
- Test substance storage: At room temperature in the dark.
- Stability under storage conditions: Stable
- Expiry date: 28 May 2012
- Sample Density: 1.28 g/cm3 (supplied by NOTOX B.V.)

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
616.757 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
< 243.412 µm
St. dev.:
11.06
Percentile:
D50
Mean:
< 545.142 µm
St. dev.:
7.67
Percentile:
D90
Mean:
< 982.119 µm
St. dev.:
12.85

Any other information on results incl. tables

0.86 % by volume of sample was seen to be < 10.00 μm

Applicant's summary and conclusion

Conclusions:
Using the laser diffraction test (‘wet’, small volume dispersion system), the Mass Median Aerodynamic Diameter (MMAD) of L-Lysine Monohydrochloride was determined to be 616.757 µm. It was also determined that 0.86 % by volume of the sample was seen to be < 10.00 μm.