Butanoic acid, 4-[[4-[7-chloro-6-(1,1-dimethylethyl)-3H-pyrazolo[1,5-b][1,2,4]triazol-2-yl]phenyl]amino]-4-oxo-, tetradecyl ester

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 January 2004 to 28 January 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of method:

sieving

Type of particle tested:

primary particle

Type of distribution:

mass based distribution

Mass median aerodynamic diameter:

175 µm

Geometric standard deviation:

8.1

No.:

#1

Size:

< 106 µm

Distribution:

13.2 %

No.:

#2

Size:

< 45 µm

Distribution:

0.05 %

No.:

#3

Size:

> 212 µm

Distribution:

24.3 %

A portion of the test substance was observed under a microscope. The test substance appeared to be irregularly shaped and light brown.

Summary of collected sieve data

Replicate	Mass Median Diameter (µm)	Mass Mean Diameter (µm)	Percent >212 µm	Percent <106 µm	Percent 75 -106 µm	Percent <45 µm
1	183.8	203.6	25.53	10.87	9.77	0.05
2	173.2	197.3	23.88	14.42	13.19	0.01
3	167.9	195.0	23.49	14.35	11.88	0.10
Mean	175	199	24.3	13.2	11.6	0.05
SD	8.1	4.5	1.08	2.03	1.73	0.045

A portion of the test substance was observed under a microscope. The test substance appeared to be irregularly shaped and light brown.

The sieve sizes appeared to be adequate to observe a defined distribution curve (Figure 1). The percent of particles <106 µm was determined to be 13.2 %. Since 11.6 % of those particles were in the size range 75-106 µm, the mass median aerodynamic diameter of the test substance was not determined based on the European Guidance Document (European Commission (1996) 'Particle Size Distribution Fibre Length and Diameter Distribution' Guidance Document).

Conclusions:

Under the conditions of the test, the mass median and median diameters of the test substance were determined to be 175 and 199 µm, respectively. The percent of particles < 106 and 45 µm was determined to be 13.2 and 0.05 % respectively. The percent of particles > 212 µm was determined to be 24.3 %.

Executive summary:

In a GLP compliant particle size study conducted in line with OECD Guideline 110, the particle size distribution of butanoic acid, 4-[[4-[7-chloro-6-(1,1-dimethylethyl)-3H-pyrazolo[1,5-b][1,2,4]triazol-2-yl]phenyl]amino]-4-oxo-, tetradecyl ester was determined using the sieve method. The mass median and mean diameters of the substance were determined to be 175 and 199 µm, respectively. The percent of particles <106 and 45µm was determined to be 13.2 and 0.05 %, respectively. The percent of particles >212 µm was determined to be 24.3 %.

Description of key information

Key study:- Hoffman (2004b) 'Particle size' conducted in line with OECD Guideline 110. The mass median and mean diameters of the test substance were determined to be 175 and 199 µm, respectively.

Additional information

The key study (Hoffman, 2004b) was performed in compliance with GLP and to the OECD Guideline 110 with a sufficient level of detail to assess the quality of the presented data. The study was performed to a good standard in line with an accepted, standardised guideline and was assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch et al. (1997). The mass median and mean diameters of the test substance were determined to be 175 and 199 µm, respectively. The percent of particles of the test substance that were <106 and 45 µm was determined to be 13.2 and 0.05 %, respectively. The percent of particles of the test substance that were >212 µm was determined to be 24.3 %.