Registration Dossier

Physical & Chemical properties

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

Reference
Name:
Unnamed
Type:
Constituent
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.