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:
From July to August 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD, EPA, etc)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

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)
Type of distribution:
other: Cascade impactor method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):XP-7866
- Physical state: white powder
- Purity test date: not supplied
- Lot/batch No.: 10188-1 JM
- Expiration date of the lot/batch: 26 February 2015
- Storage condition of test material: room temperature, in the dark

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Too few particles were of a size less than 10.0 IJm to allow accurate assessment of the mass median aerodynamic diameter.(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

Any other information on results incl. tables

* Particle size data acquired for the test item (overall cumulative percentage of test item):

 Measurement  Method  Result
 Proportion of test item having an inhalable particle size < 100 µm  sieve  28.6%
 Proportion of test item having a thoracic particle size < 10.0 µm  Cascade Impactor  8.15%
  Proportion of test item having a respirable particle size <5.5 µm   Cascade Impactor  0.916%

Note: Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes then sampled from the top, middle and bottom.

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.

* Detailed results:

1) Screening test (sieve method)

 Measurement  Result
 Mass of test item transferred to sieve  11.61 g
 Mass of test item passed through sieve  3.32 g
 Proportion of test < 100 µm  28.6%

2) Definitive test (cascade impactor method)

For detailed results on determination 1, 2 & 3, refer to the below attachment.

Applicant's summary and conclusion

Conclusions:
Particle size data of the registered itemwas distributed as followed:
* Proportion of test item having an inhalable particle size < 100 µm - 28.6% (Sieve method)
* Proportion of test item having a thoracic particle size < 10.0 µm - 8.15% (Cascade Impactor method)
* Proportion of test item having a respirable particle size <5.5 µm - 0.916% (Cascade Impactor method)
Executive summary:

Particle size data of the registered item were acquired, using a procedure designed to be compatible 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, 12 May 1981. The results are as follows:

Proportion of test item having an inhalable particle size < 100 µm  sieve method  28.6%
Proportion of test item having a thoracic particle size < 10.0 µm  Cascade Impactor method  8.15%
Proportion of test item having a respirable particle size <5.5 µm   Cascade Impactor method  0.916%