Adenosine

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 guideline

Test guideline 1

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Test guideline 3

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

Test material information

Constituent 1

Reference substance name:

Adenosine

EC Number:

200-389-9

EC Name:

Adenosine

Cas Number:

58-61-7

Molecular formula:

C10H13N5O4

IUPAC Name:

adenosine

impurity 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Oxidane

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 size

Particle size 1

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)

Particle size 2

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)

Particle size 3

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).