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:
17.01.2018 - 06.02.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DM 13.9.1999 G.U.n°248 del 21/10/1999
Deviations:
no
GLP compliance:
not specified
Other quality assurance:
other: UNI EN ISO 9001:2015
Remarks:
Chemical, technological, sanitary and eco-toxicological analyses. Technical and scientific services, consulting and design of materials for biomedical and technological manufacturing fields (IAF 34)
Type of method:
cascade impaction
Type of particle tested:
aggregate
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
not specified
Details on test material:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 20170710
- Expiration date of the lot/batch: not specified
- Purity test date: not specified

RADIOLABELLING INFORMATION (if applicable)
not applicable


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not relevant
- Final dilution of a dissolved solid, stock liquid or gel: not relevant
- Final preparation of a solid: not relevant

FORM AS APPLIED IN THE TEST: solid (powder).

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
not applicable

OTHER SPECIFICS: not specified

Results and discussion

Geometric standard deviation:
>= 76 - <= 92
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 1 mm
Distribution:
21.38 %
No.:
#2
Size:
> 250 - < 500 µm
Distribution:
58.93 %
No.:
#3
Size:
> 105 - < 249 µm
Distribution:
15.77 %
No.:
#4
Size:
> 50 - < 100 µm
Distribution:
25.23 %

Any other information on results incl. tables

The particle size of the substance was confirmed by electronic microscope scanning

Applicant's summary and conclusion

Conclusions:
The particle size distribution of the substance was:
21,38% m/m (<1mm)
58,93% m/m (500-250μm)
15,77% m/m (249-105μm)
25,23% m/m (100-50μm)