Reaction product of {Sulfonic acid derivatives of [4-(aminoalkylamino)-6-substituted-1,3,5-triazin-2-ylamino]benzene}, ammonia water, sodium chloride and [poly(1~4)chlorosulfonyl(poly(1~4) benzo-poly(3~0)pyrido-5,10,15,20-tetraazaporphyrinato- N21,N22,N23,N24)]copper(II)

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Phys chem testing was conducted between 10 March 2011 and 12 April 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: TM10-099
Description: dark blue powder
Batch number: MB-1
Date received: 4 March 2011
Expiry date: 4 March 2012
Storage conditions: room temperature in the dark

Results and discussion

Particle size

Percentile:

D50

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

37.5 %

Remarks on result:

other: Screening test

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

0.098 %

Remarks on result:

other: Definitive test

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

0.078 %

Remarks on result:

other: Definitive test

Particle size distribution at different passages 4

No.:

#4

Size:

< 2.4 µm

Distribution:

0.06 %

Remarks on result:

other: Definitive test

Particle size distribution at different passages 5

No.:

#5

Size:

< 1.61 µm

Distribution:

0.041 %

Remarks on result:

other: Definitive test

Particle size distribution at different passages 6

No.:

#6

Size:

< 0.307 µm

Distribution:

0.021 %

Remarks on result:

other: Definitive test

Any other information on results incl. tables

Measurement	Method	Result (%)
Proportion of test item having an inhalable particle size <100 µm	Sieve	37.5
Proportion of test item having a thoracic particle size <10.0 µm	Cascade Impactor	0.0982
Proportion of test item having a respirable particle size <5.5 µm	Cascade Impactor	0.0783

Discussion:

Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.

Applicant's summary and conclusion

Conclusions:

37.5 %, 0.0982 % and 0.0783 % of the particles were determined to have a diameter smaller than 100 µm, 10 µm and 5.5 µm, respectively.

Executive summary:

The particle size distribution of the test item TM10-099 was determined in a valid GLP study in accordance with OECD TG No. 110.

In a screening study, the percentage of particles with a diameter smaller than 100 µm was determined to be 37.5% by the sieve method. In the definitive study, the cascade impactor method was used and the percentage of particles with a diameter smaller than 10 µm and 5.5 µm was determined to be 0.0982 and 0.0783 %, respectively