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 26 October 2009 and 19 November 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 do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Version / remarks:
The method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 19-08-2008 Date of Signature: 04-09-2009
Type of distribution:
other: The method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: DMH
Description: white crystalline solid
Batch number: N5439431
Date received: 24 February 2006
Storage conditions: room temperature in the dark

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
other: As only a small amount passed through the 100µm sieve, the test material was considered to be essentially non-inhalable.
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Mean:
other: Not applicable
Particle size distribution at different passages
No.:
#1
Size:
> 100 µm
Distribution:
4.09 %

Any other information on results incl. tables

Results

 Screening test (sieve method)

The results of the sieving procedure are shown in the following table:

Table 10.1

Measurement

Result

Mass of test material transferred to sieve

12.22g

Mass of test material passed through sieve

0.50g

Percentage of test material less than 100 µm

4.09%

Applicant's summary and conclusion

Conclusions:
The proportion of test material having a particle size less than 100µm has been determined to be 4.09%. The test material is essentially non-inhalable.
Executive summary:

Method

The method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.

Procedure

Screening test (sieve method)

Test material (12.22 g) was sieved for approximately 30 minutes on an Inclyno sieve shaker using a 100 µm sieve. The mass of test material passing through the sieve was measured.

Conclusion

The proportion of test material having a particle size less than 100µm has been determined to be 4.09%. The test material is essentially non-inhalable.