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 the 15th May 2018 and the 18th May 2018.
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: compatible with 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
Type of particle tested:
primary particle
Type of distribution:
mass based distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 4,4'-methylenediphenol and 2,2'-methylenediphenol and o-[(4-hydroxyphenyl)methyl]phenol
EC Number:
908-912-9
Cas Number:
1333-16-0
Molecular formula:
C39H36O6
IUPAC Name:
Reaction mass of 4,4'-methylenediphenol and 2,2'-methylenediphenol and o-[(4-hydroxyphenyl)methyl]phenol
Test material form:
solid
Specific details on test material used for the study:
Identification: Dihydroxydiphenylmethane (Bisphenol-F)
CAS#: 1333-16-0
Appearance/Physical state: pale pink lumps
Lot No: C817
Purity: 91.41%
Expiry date: 01 November 2018
Storage conditions: room temperature, in the dark

Results and discussion

Particle size distribution at different passages
No.:
#1
Size:
> 100 µm
Distribution:
0.16 %

Any other information on results incl. tables

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.

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 0.16%. The test item has been considered to be essentially non-inhalable.
Executive summary:

Particle Size Distribution: The proportion of test item having an inhalable particle size of less than 100 μm was determined by a sieve method to be 0.16%, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).