[No public or meaningful name is available]

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 16 May 2008 and 02 July 2008.

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:

2008

Report date:

2008

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)

Remarks:

The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).

Test material

Test material information

Constituent 1

Results and discussion

Particle size

Percentile:

D50

Mean:

other: Not determined.

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size distribution at different passages

No.:

#1

Size:

< 100 µm

Distribution:

4.04 %

Any other information on results incl. tables

Results

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)	15.36
Mass of test material passed through sieve (g)	0.62
Test material less than sieve aperture size (%)	4.04

Discussion

Due to the physical appearance of the test material, i.e. relatively large irregular-shaped clumps of aggregated material which do not break up easily, definitive testing was considered impractical.

Therefore, on review, the screening test result is considered to significantly overestimate the percentage less than 100 µm due to mechanical breakdown of these clumps during the 30 minute shaking period.  A visual observation of the test material indicated very little fine material.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth.

Conclusion

The proportion of test material having an inhalable particle size less than 100µm was determined to be 4.04%.

Applicant's summary and conclusion

Conclusions:

The proportion of test material having an inhalable particle size less than 100µm was determined to be 4.04%.

Executive summary:

For substance NDS-Li in project number 1307 -0447, 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 Guideline 110. The proportion of test material having an inhalable particle size less than 100µm was determined to be 4.04%.