L-Lysine, N2,N6-bis[N-(1-oxododecyl)glutamyl]-, sodium salt (1:?)

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 13th July 2009 and 30 July 2009.

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 did not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of signature: 04/03/2009 Date of inspection: 19/08/2008

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

Pellicer

IUPAC Name:

Pellicer

Details on test material:

Sponsors identification: Pellicer
Description : white solid
Batch number : 01_09_17
Date received : 26 June 2009
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:

16 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

0.022 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

0.008 %

Any other information on results incl. tables

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:

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

Executive summary:

Particle size data has been acquired using a procedure designed to comply with the European Comission technical guidance document Particle Size Distribution, Fibre Length and Diameter Distribution: (June 1996),which Satisfies the requirements of OECD Guideline 110.

The results show that 16% of particles are at a size < 100µm.