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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:
15 Mar 17 - 27 Feb 18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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
Guideline:
other: EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).
Version / remarks:
compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving

Test material

1
Chemical structure
Reference substance name:
2-(2H-benzotriazol-2-yl)-4-tert-butylphenol
EC Number:
221-574-0
EC Name:
2-(2H-benzotriazol-2-yl)-4-tert-butylphenol
Cas Number:
3147-76-0
Molecular formula:
C16H17N3O
IUPAC Name:
2-(5-tert-Butyl-2-hydroxyphenyl)benzotriazole
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: 02002IX3
- Expiration date of the lot/batch: 28 February 2018
- Purity: 99.9 %
- Physical appearance: White powder.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark

Results and discussion

Remarks on result:
not measured/tested
Remarks:
Based on the limited proportion of the test item determined to be in the inhalable particle size range (<100 µm), further evaluation of the test item by the cascade impactor method was not considered necessary or meaningful.
Particle size
Key result
Remarks on result:
not measured/tested
Remarks:
Based on the limited proportion of the test item determined to be in the inhalable particle size range (<100 µm), further evaluation of the test item by the cascade impactor method was not considered necessary or meaningful.

Any other information on results incl. tables

Significantly greater than 50% of test item (by mass) must present an aerodynamic equivalent diameter of 10 µm or less in order to generate validmass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) datafor the thoracic and respirable fractions.

Applicant's summary and conclusion

Conclusions:
The percentage of test item having an inhalable particle size of less than 100 µm was determined to be 7.47%.