N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide

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:

Between 12 February and 30 March 2012.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

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:

agglomerate

Type of distribution:

mass based distribution

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

No.:

#1

Size:

< 100 µm

Distribution:

ca. 7.32 %

Remarks on result:

other: The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 7.32 %. The test item has been considered to be essentially non-inhalable.

No.:

#2

Size:

>= 100 µm

Distribution:

ca. 92.68 %

Results

The results of the sieving procedure are shown in the following table:

Table 3.18

Measurement	Result
Mass of test item transferred to sieve	10.93 g
Mass of test item passed through sieve	0.80 g
Proportion of test item <100 µm	7.32 %

 

Conclusions:

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 7.32 %. The test item has been considered to be essentially non-inhalable.

Executive summary:

The method used was based on a procedure designed to be compatible with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110, 12 May 1981.

Results

The results of the sieving procedure are shown in the following table:

Table 3.18

Measurement	Result
Mass of test item transferred to sieve	10.93 g
Mass of test item passed through sieve	0.80 g
Proportion of test item <100 µm	7.32 %

 

Conclusion

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 7.32 %. The test item has been considered to be essentially non-inhalable.

Description of key information

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 7.32 %. The test item has been considered to be essentially non-inhalable.