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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:
19 August 2015 - 25 August 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
Principles of method if other than guideline:
According to REACH Regulation (EC) No 1907/2006 Article 13(3) tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. No particle size distribution test method is laid down in the relevant Regulation (EC) No 440/2008. The international OECD 110 test guideline ‘Particle Size Distribution/FibreLength and Diameter Distributions’ dates from 1981 and describes two methods in detail; both methods have restrictions and are not applicable to the entire size range. ECHA’s document ‘Guidance on information requirements and Chemical SafetyAssessment-Chapter R.7a: Endpoint specific guidance’ stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. ECHA’s guidance mentions the Laser scattering/diffraction as a method suitable for particles of all kind and makes reference to ISO 13320:2009.
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
(2S)-2-(1,3-DIOXO-2,3-DIHYDRO-1H-ISOINDOL-2-YL)PENTANEDIOIC ACID
EC Number:
608-945-6
Cas Number:
340-90-9
Molecular formula:
C13H11NO6
IUPAC Name:
(2S)-2-(1,3-DIOXO-2,3-DIHYDRO-1H-ISOINDOL-2-YL)PENTANEDIOIC ACID
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name (as cited in study report): Phthalyl-L-Glu
- Appearance: white powder
- Storage conditions: room temperature in the dark
- Relative density: 1.53 (see Endpoint 4.4)
- Tested as received (no pre-sieving required)

Results and discussion

Mass median aerodynamic diameter:
>= 20.056 - <= 20.269 µm
Geometric standard deviation:
> 2.001 - < 2.005
Particle sizeopen allclose all
Percentile:
D10
Mean:
5.794 µm
St. dev.:
0.033
Percentile:
D50
Mean:
16.302 µm
St. dev.:
0.061
Percentile:
D90
Mean:
79.859 µm
St. dev.:
1.51
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 5.79 µm
Distribution:
10 %
No.:
#2
Size:
< 10 µm
Distribution:
22.9 %
No.:
#3
Size:
< 16.3 µm
Distribution:
50 %
No.:
#4
Size:
< 80 µm
Distribution:
90 %

Any other information on results incl. tables

Mean (n=5) MMAD: 20.17 µm (population standard deviation: 0.08 µm)

Mode: 15.565 µm

 

The coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320 -1 standard.

Applicant's summary and conclusion

Conclusions:
In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using laser diffraction analysis ('wet' small volume dispersion method), the particle size distribution of the substance was determined: 10% < 5.79 µm; 22.9% < 10.00 µm; 50% < 16.3 µm; 90% < 80 µm. The MMAD is 20.2 µm.

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