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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:
05 December 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Version / remarks:
1996
Deviations:
no
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:
Adenosine 5'-(tetrahydrogen triphosphate), disodium salt
EC Number:
213-579-1
EC Name:
Adenosine 5'-(tetrahydrogen triphosphate), disodium salt
Cas Number:
987-65-5
Molecular formula:
C10H14N5O13P3.2Na
IUPAC Name:
disodium 9-{5-O-[hydroxy({[(hydroxyphosphinato)oxy]phosphinato}oxy)phosphoryl]pentofuranosyl}-9H-purin-6-amine
impurity 1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Oxidane
impurity 2
Reference substance name:
Unknown impurities.
Molecular formula:
Not available as unknown impurities.
IUPAC Name:
Unknown impurities.
Test material form:
solid: crystalline
Details on test material:
Storage conditions: 2-8°C
Batch No: 11678500
Specific details on test material used for the study:
Since the test item contains no lager particles, sieving < 2000 µm was not necessary and the test item was used as delivered.

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
1.1 µm
St. dev.:
0.018
Remarks on result:
other: Average result calculated from the results of two test series
Key result
Percentile:
D50
Mean:
12.8 µm
St. dev.:
0.58
Remarks on result:
other: Average result calculated from the results of two test series
Key result
Percentile:
D90
Mean:
199.3 µm
St. dev.:
0.9
Remarks on result:
other: Average result calculated from the results of two test series

Any other information on results incl. tables

Visual Microscope Analysis

(1) under a microscope with 5x magnification agglomerates can be observed

(2) under a microscope with 20x magnification agglomerates can be observed

(3) under a microscope with 50x magnification, the test item consists of almost spherical particles at lower particle sizes

Particle Size Distribution

The test item shows a bimodal particle size distribution with two peaks at approx. 4 µm and 90 µm.

Test series 1:

 Percentile  Particle size (µm)  Standard deviation
 D10  1.1  0.003
 D50  13.4  0.58
 D90  198.4 5.91

Test series 2:

 Percentile  Particle size (µm)  Standard deviation
 D10  1.1  0.015
 D50  12.3  0.40
 D90  200.2 12.26

Applicant's summary and conclusion

Conclusions:
The test item ATP, Di-Na (CAS 987-65-5) has a median particle size D50 = 12.8 µm, which was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Guideline OPPTS 830.7520 (1996).
Executive summary:

The test item ATP, Di-Na (CAS 987 -65 -5) has a median particle size D50= 12.8 µm, which was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Guideline OPPTS 830.7520 (1996).

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