A mixture of: 2,4 -bis(N'-(4-methylphenyl)ureido)toluene; 2,6 -bis(N'-(4-methylphenyl)ureido)toluene

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 13, 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study has been performed similar to BS ISO 13320-1: 1999, OECD 110 and according to GLP principles. Limited information available to verify the composition of the used test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: BS ISO 13320-1: 1999

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

not specified

Principles of method if other than guideline:

Although these guidelines are not mentioned in the report, it is mentioned that the test equipment and method are recognised by OECD guidelines.

GLP compliance:

yes (incl. QA statement)

Type of method:

determination of fibre length and diameter distributions

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: 2,4 -bis(N'-(4-methylphenyl)ureido)toluene; 2,6 -bis(N'-(4-methylphenyl)ureido)toluene

EC Number:

411-070-0

EC Name:

A mixture of: 2,4 -bis(N'-(4-methylphenyl)ureido)toluene; 2,6 -bis(N'-(4-methylphenyl)ureido)toluene

Molecular formula:

C23H24N4O2

IUPAC Name:

3-(2-methyl-5-{[(4-methylphenyl)carbamoyl]amino}phenyl)-1-(4-methylphenyl)urea

Details on test material:

- Name of test material (as cited in study report): KY-ET
- Appearance: white powder
- Storage condition of test material: at room temperature in the dark

Results and discussion

Particle size

Particle size 1

Percentile:

D50

Remarks on result:

other: MMAD: not determined(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

Particle size 2

Percentile:

D50

Mean:

15.37 µm

St. dev.:

3.69

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

1.437 µm

Distribution:

< 10 %

Remarks on result:

other: Average of 3 runs

Particle size distribution at different passages 2

No.:

#2

Size:

4.945 µm

Distribution:

< 25 %

Remarks on result:

other: Average of 3 runs

Particle size distribution at different passages 3

No.:

#3

Size:

15.37 µm

Distribution:

< 50 %

Remarks on result:

other: Average of 3 runs

Particle size distribution at different passages 4

No.:

#4

Size:

33.95 µm

Distribution:

< 75 %

Remarks on result:

other: Average of 3 runs

Particle size distribution at different passages 5

No.:

#5

Size:

51.71 µm

Distribution:

< 90 %

Remarks on result:

other: Average of 3 runs

Any other information on results incl. tables

Optical Microscope Analysis

- Standard visual observation: Sample observed to be a free-flowing, fine, white powder which forms clusters

- Observation at 100 x magnification: The particles appeared to be amorphous crystals of irregular shape.The smallest particle size was approx. 7.5 μm and the largest size was approx. 103 μm. The particle size distribution was approx. 80% < 80 μm and 20% ≥ 80 μm.

- Observation at 400 x magnification: The sample was observed to be made up of single crystalline particles.

Manual sieve analysis

Not used. The sample was analysed as received.

Laser diffraction particle size analysis

- Run 1 failed to meet the Coulter obscuration requirements and is therefore excluded from the results;

	RUN 2	RUN 3	RUN 4	Average
Volume %	100.0	100.0	100.0	100.0
Mean (µm)	12.42	12.47	10.08	11.60
Median (µm)	17.16	16.39	13.00	15.37
Mode (µm)	51.12	55.99	42.61	51.12
95% Conf. Limit (µm)	0.943 -164	0.936 -166	0.842 -121	0.899 -150
S.D.	3.73	3.75	3.55	3.69

Applicant's summary and conclusion

Conclusions:

According to GLP principles the particle size distribution of the substance was determined using laser diffraction analysis. The median (D50) of the analysed sample was 15.37 µm.