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:
25/09/2006 = 12/10/2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No guideline is specified within the text of the report.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Remarks:
Given the use of a Mastersizer 2000, the method must have been laser diffraction as this is how this equipment measures particle size.

Test material

Constituent 1
Chemical structure
Reference substance name:
Pidolic acid
EC Number:
202-700-3
EC Name:
Pidolic acid
Cas Number:
98-79-3
Molecular formula:
C5H7NO3
IUPAC Name:
(2S)-5-oxopyrrolidine-2-carboxylic acid
Test material form:
solid: particulate/powder
Details on test material:
white solid crystalline powder

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
15.629 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
The standard deviation is not provided in the results
Percentile:
D50
Mean:
146.172 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
The standard deviation is not provided in the results
Percentile:
D90
Mean:
571.592 µm
St. dev.:
0
Remarks on result:
other:
Remarks:
The standard deviation is not provided in the results

Applicant's summary and conclusion

Conclusions:
Less than 10% of the substance has a particle size below 15.629 µm.
Executive summary:

Using a Malvern Mastersizer 2000, the particle size has been determined. Less than 10% of the test material has a particle size below 15.629 µm.