Barium, 1,4-bis (C13-rich C11-14-isoalkyl) 2-sulfobutanedioate phosphate complex

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 08 February 2008 and 11 March 2008.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Date of inspection: 21/08/2007 Date of signature: 15/10/2007

Type of distribution:

other: not stated

Test material

Test material information

Constituent 1

Reference substance name:

dibarium(2+) bis(1,5-dioxo-1,5-bis(tridecyloxy)pentane-3-sulfonate) hydrogen phosphate

EC Number:

931-037-9

Molecular formula:

Molecular formula for each combination of chain length. C13,13: (C30H57O7S)2 Ba @ BaHOP4 C11,12: (C27H51O7S)2 Ba @ BaHOP4 C12,12: (C28H53O7S)2 Ba @ BaHOP4 C12,13: (C29H55O7S)2 Ba @ BaHOP4 C13,14: (C31H59O7S)2 Ba @ BaHOP4 C14,14: (C32H61O7S)2 Ba @ BaHOP4

IUPAC Name:

dibarium(2+) bis(1,5-dioxo-1,5-bis(tridecyloxy)pentane-3-sulfonate) hydrogen phosphate

Details on test material:

Sponsor's identification: Barium di(bistridecylsulfosuccinate) in mixture with Barium hydrogen phosphate
Description : pale yellow solid
Batch number : Y-T-1
Storage conditions: room temperature, in the dark

Results and discussion

Particle size

Percentile:

D50

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:

< 0.1 %

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)	15.05
Mass of test material passed through sieve (g)	0.01
Test material less than sieve aperture size (%)	<0.1

Applicant's summary and conclusion

Conclusions:

Less than 0.1% of the test material was determined to have a particle size less than 100 µm. Therefore the test material is of a particle size that is essentially non-inhalable.

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. Less than 0.1% of the test material was determined to have a particle size less than 100 µm. Therefore the test material is of a particle size that is essentially non-inhalable.