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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Follows a recognised guideline and conforms to GLP standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle size
Percentile:
D50
Mean:
> 100 µm
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 passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
44.4 %
No.:
#2
Size:
< 10 µm
Distribution:
<= 0.638 %
No.:
#3
Size:
< 5.5 µm
Distribution:
<= 0.296 %

Any other information on results incl. tables

Screening test results

 Sieve aperture size (micrometres) 100 
Mass of test material transferred to sieve (g)  11.35 
Mass of test material passed through sieve (g)  5.04 
Test material less than sieve size (%)  44.4 

Definitive test results:

Overall cumulative amounts of trisodium 6,6',6"-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoate with a particle size less than 10.0 micrometres (%) from determinations 1 - 3:

Determination Cumulative amount of test material less than 10.0 micrometres (%) Overall cumulative amount of test material less than 10.0 micrometres (%)
1 0.383 </= 0.638
2 0.601
3 0.638

Overall cumulative amounts of test material with a particle size less than 5.5 micrometres (%) from determinations 1 - 3:

Determination Cumulative amount of test material less than 10.0 micrometres (%) Overall cumulative amount of test material less than 10.0 micrometres (%)
1 8.06E-02 = 0.296
2 0.262
3 0.296

Applicant's summary and conclusion

Conclusions:
Particle size data acquired for trisodium 6,6',6"-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoate is as follows:
Proportion of trisodium 6,6',6"-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoate having an inhalable particle size less than 100 μm (sieve method): 44.4%.
Proportion of test material having a thoracic particle size less than 10.0 μm (Cascader impactor method): Proportion of test material having a respirable particle size less than 5.5 μm (Cascader impactor method):