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:
February 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Principles of method if other than guideline:
Laser diffraction method - The test was conducted according to the guidance of the apparatus used. A short description is given below:
The dry test substance is dispersed and passes a laser in form of an aerosol. In dependence on the particle size the laser is diffracted. The resulting so called “Fraunhofer” diffraction spectrum is bundled using a converging lens in a multi-element photo detector. In dependence of the particle size distribution a radial symmetric intensity distribution is generated. The measured intensity is analysed by a computer and converted into a particle size distribution.
GLP compliance:
yes
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
solid: bulk

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D25
Mean:
ca. 1 µm
Remarks on result:
not measured/tested
Key result
Percentile:
D50
Mean:
ca. 1.8 µm
Remarks on result:
not measured/tested
Key result
Percentile:
D90
Mean:
ca. 5 µm
Remarks on result:
not measured/tested
Key result
Percentile:
D99
Mean:
ca. 10.5 µm
Remarks on result:
not measured/tested

Any other information on results incl. tables

Parameter

Result

Method

25 % of the sample

Particle size

≤ 1.0 µm

Laser Difffraction

50 % of the sample

Particle size

≤ 1.8 µm

Laser Difffraction

90 % of the sample

Particle size

≤ 5.0 µm

Laser Difffraction

99% of the sample

Particle size

≤ 10.5 µm

Laser Difffraction

Applicant's summary and conclusion

Conclusions:
The median value of particle size of MDI urone is 1.8 µm.
Executive summary:

The granulometric properties of MDI urone were analysed with the laser diffraction method according to guideline ISO 13320 -1. The particle size distribution was determined using the particle size analysator HELOS KF (H0119) from Sympatec with a Sympatec RODOS dry dispersing unit. The test material was dried via dispersing and run in form of an aerosol fluent through a laser beam. The median value of particle size is 1.8 µm.