Urea, N,N''-(methylenedi-4,1-phenylene)bis[N',N'-dimethyl-

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

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

Test material information

Constituent 1

Reference substance name:

-

EC Number:

423-370-9

EC Name:

-

Cas Number:

10097-09-3

Molecular formula:

C19H24N4O2

IUPAC Name:

1-[4-({4-[(dimethylcarbamoyl)amino]phenyl}methyl)phenyl]-3,3-dimethylurea

impurity 1

Reference substance name:

unknown

IUPAC Name:

unknown

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Water

Test material form:

solid: bulk

Results and discussion

Particle size

Particle size 1

Key result

Percentile:

D25

Mean:

ca. 1 µm

Remarks on result:

not measured/tested

Particle size 2

Key result

Percentile:

D50

Mean:

ca. 1.8 µm

Remarks on result:

not measured/tested

Particle size 3

Key result

Percentile:

D90

Mean:

ca. 5 µm

Remarks on result:

not measured/tested

Particle size 4

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.