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: Study report by GLP compliant laboratory

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: laser diffraction method
GLP compliance:
yes
Type of distribution:
counted distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
ca. 56.5 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
other: 20%
Mean:
< 11.3 µm
Remarks on result:
other: No standard deviation applicable.

Applicant's summary and conclusion

Conclusions:
The median particle diameter is ca 56.5µm
Executive summary:

Particle size analysis performed on a 2009 batch of the substance from the non-EU source suggests a mean particle size that is a possible risk of inhalation and risk management measures will include precautions to prevent generation or dust and recommendations to wear dust masks and work in good areas of ventilation. There was considered to be insufficient risk of exposure to perfomr an inhaltion toxicity study.