Menadione

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental starting date: 05 July 2017. Experimental completion date: 23 August 2017

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 guideline

Qualifier:

according to guideline

Guideline:

other:

Version / remarks:

European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

Deviations:

no

Principles of method if other than guideline:

The determination was carried out using a procedure designed to be compatible with European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

Menadione

EC Number:

200-372-6

EC Name:

Menadione

Cas Number:

58-27-5

Molecular formula:

C11H8O2

IUPAC Name:

2-methyl-1,4-dihydronaphthalene-1,4-dione

Specific details on test material used for the study:

Identification: Beta-Menadione
CAS No: 58-27-5
Description: light yellow powder
Batch number: J16090701
Purity: 99.2%
Expiry date: 06 September 2017
Storage conditions: room temperature, in the dark

Results and discussion

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 10 µm

Distribution:

>= 0.452 - <= 0.869 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 5.5 µm

Distribution:

>= 0.046 - <= 0.12 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 2.4 µm

Distribution:

>= 0.003 - <= 0.045 %

Particle size distribution at different passages 4

No.:

#4

Size:

< 1.61 µm

Distribution:

>= 0 - <= 0.003 %

Particle size distribution at different passages 5

No.:

#5

Size:

< 0.307 µm

Distribution:

>= 0 - <= 0.003 %

Any other information on results incl. tables

Sieve Screening Test

The results of the sieving procedure are shown in the following table:

Measurement	Result
Mass of test item transferred to sieve (W1)	14.75 g
Mass of test item passed through sieve (W3 – W2)	8.35 g
Percentage of test item less than 100 μm	56.60%

Cascade Impactor

The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table:

Particle Size Cut Points (μm)	Cumulative Mass (g)			Cumulative Percentage (%)
	Determination 1	Determination 2	Determination 3	Determination 1	Determination 2	Determination 3
<10.0	0.0189	0.026	0.0138	0.611	0.869	0.452
<5.5	0.0037	0.0021	0.0014	0.12	0.07	0.046
<2.4	0.0014	0.0001	0.0002	0.045	0.003	0.007
<1.61	0.0001	0	0	0.003	0	0
<0.307	0.0001	0	0	0.003	0	0

Mean cumulative percentage with a particle size less than 10.0 μm : 0.644% Mean cumulative percentage with a particle size less than 5.5 μm : 0.079%

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes then sampled from the top, middle and bottom.

Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Applicant's summary and conclusion

Conclusions:

Particle size data acquired for the test item is:
Percentage of test item with an inhalable particle size <100 μm: 56.6 % (Sieve Method)
Percentage of test item with a thoracic particle size <10.0 μm: 0.644 % (Cascade impactor method)
Percentage of test item with a respirable particle size <5.5 μm: 0.079 % (Cascade impactor method)

Executive summary:

Particle Size Distribution.. Particle size data was acquired, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002). The results are as follows:

Measurement	Method	Result
Proportion of test item having an inhalable particle size <100 μm	Sieve	56.60%
Proportion of test item having a thoracic particle size <10.0 μm	Cascade Impactor	0.64%
Proportion of test item having a respirable particle size <5.5 μm	Cascade Impactor	0.08%