(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21st August 2006 to 24th August 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Details on test material:

Sponsor's identification: Experimental 20105-68

Results and discussion

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

13.2 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10.2 µm

Distribution:

9.72 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.4 µm

Distribution:

1.4 %

Any other information on results incl. tables

Screening test (sieve method)

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

Sieve aperture size (µm)	100
Mass of test material transferred to sieve (g)	17.13
Mass of test material pass through sieve (g)	2.26
Test material less than sieve aperture size (%)	13.2

 

The overall cumulative amounts of test material with a particle size less than 10.2 µm (%) from Determinations 1 to 3 are shown in the following table:

Determination	Cumulative amount of test material with a particle size less than 10.2 µm (%)	Mean cumulative amount of test material with a particle size less than 10.2 µm (%)
1	9.48	9.72
2	9.80
3	9.89

 

The overall cumulative amounts of test material with a particle size less than 5.4 µm (%) from Determinations 1 to 3 are shown in the following table:

Determination	Cumulative amount of test material with a particle size less than 5.4 µm (%)	Mean cumulative amount of test material with a particle size less than 5.4 µm (%)
1	1.50	1.40
2	1.31
3	1.38

 

Too few particles were of a size less than 10.2 µm to allow accurate assessment of mass median aerodynamic diameter.

Representative sampling was ensured by rolling the sample container for approximately 10 minutes and sampling from the top, middle and bottom prior to definitive testing.

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 material are as follows:

Proportion of the test material having an inhalable particle size less than 100 µm: 13.2%
Proportion of the test material having a thoracic particle size less than 10.2 µm: 9.72%
Proportion of the test material having a respirable particle size less than 5.4 µm: 1.40%

Executive summary:

Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance document "Particle Size Distribution, Fibre Length and Diameter Distribution" (June 1996), which satisfies the requirements of OECD Guideline 110. The results are as follows:

Proportion of test material having an inhalable particle size less than 100 µm: 13.2% (sieve method)

Proportion of test material having a thoracic particle size less than 10.2 µm: 9.72% (Cascade Impactor method)       

Proportion of test material having a respirable particle size less than 5.4 µm: 1.40% (Cascade Impactor method)