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:
20 October 2017 - 23 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
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:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid: particulate/powder
Details on test material:
Batch No.: 10004539
Storage at room temperature approx. 20°C
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:
11.8 µm
St. dev.:
0.31
Remarks on result:
other: Average result calculated from the results of two test series (12.1 µm; 11.4 µm)
Key result
Percentile:
D50
Mean:
39.9 µm
St. dev.:
0.9
Remarks on result:
other: Average result calculated from the results of two test series (40.8 µm; 39.0 µm)
Key result
Percentile:
D90
Mean:
93.9 µm
St. dev.:
5.59
Remarks on result:
other: Average result calculated from the results of two test series (99.5 µm; 88.3 µm)

Any other information on results incl. tables

Visual Microscope Analysis

(1) under a microscope with 5x magnification no bigger particles or agglomerates can be observed.

(2) under a microscope with 20x magnification no bigger particles or agglomerates can be observed.

(3) under a microscope with 50x magnification the test item primarily consists of rectangular crystalline particles.

Particle Size Distribution

The test item shows a unimodal particle size distribution with one peak at approx. 40 µm.

Test series 1:

 Percentile  Particle size (µm)  Standard deviation
 D10  12.1  0.07
 D50  40.8  0.56
 D90  99.5 6.88

Test series 2:

 Percentile  Particle size (µm)  Standard deviation
 D10  11.4  0.13
 D50  39.0  0.29
 D90  88.3 1.78

Applicant's summary and conclusion

Conclusions:
The test item Adenosine (CAS 58-61-7) has a median particle size D50= 39.9 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 Adenosine (CAS 58-61-7) has a median particle size D50= 39.9 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).