Triazine derivative

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Testing was conducted between 27 March 2007 and 11 June 2007.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

The method used is designed to comply with that given in "Particle Size Distribution, Fibre Length and Diameter Distribution", June 1996 European Commission technical guidance document, which satisfies the requirements of OECD 110.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of distribution:

volumetric distribution

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Sponsor's identification: C-Y9
Description : yellow powder
Lot number : MB-1
Date received : 6 March 2007
Storage conditions: room temperature in the dark, over silica gel

Results and discussion

Particle size

Percentile:

D50

Remarks on result:

other: Too few particles were of a size less than 10.0 µm to allow accurate assessment of mass median aerodynamic diameter.(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

34.3 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

3.18 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

0.505 %

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)	10.50
Mass of test material passed through sieve (g)	3.60
Test material less than sieve aperture size (%)	34.3

 

Definitive test (cascade impactor method)

The overall cumulative amounts of test material with a particle size less than 10.0 µm (%) from Determinations 1 to 3 are shown in the following table:

Determination	Cumulative Amount of Test Material Less Than 10.0 µm (%)	Mean Cumulative Amount of Test Material Less Than 10.2 µm (%)
1	3.862	3.18
2	2.853
3	2.811

 The overall cumulative amounts of test material with a particle size less than 5.5 µm (%) from Determinations 1 to 3 are shown in the following table:

Determination	Cumulative Amount of Test Material Less Than 5.5 µm (%)	Mean Cumulative Amount of Test Material Less Than 5.5 µm (%)
1	0.650	0.505
2	0.488
3	0.378

Discussion

Too few particles were of a size less than 10.0 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:
Proportion of test material having an inhalable particle size less than 100 µm: 34.3%
Proportion of test material having a thoracic particle size less than 10.0 µm: 3.18%
Proportion of test material having a respirable particle size less than 5.5 µm: 0.505%

Executive summary:

Particle Size Distribution. 

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:

Measurement	Method	Result
Proportion of test material having an inhalable particle size less than 100 µm	Sieve	34.3%
Proportion of test material having a thoracic particle size less than 10.0 µm	Cascade Impactor	3.18%
Proportion of test material having a respirable particle size less than 5.5 µm	Cascade Impactor	0.505%