1,2,3,4-Butanetetracarboxylic acid, tetramethyl ester, reaction products with 1,2,2,6,6-pentamethyl-4-piperidinol and β,β,β',β'-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: Procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002).

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

cascade impaction

Type of particle tested:

primary particle

Mass median aerodynamic diameter:

other:

Remarks on result:

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

Key result

Remarks on result:

not determinable

No.:

#1

Size:

< 100 µm

Distribution:

84.7 %

No.:

#2

Size:

< 10 µm

Distribution:

2.07 %

No.:

#3

Size:

< 5.5 µm

Distribution:

< 1.34 %

Conclusions:

Particle size data acquired for the test item is as follows:
Percentage of test item with an inhalable particle size <100 μm - 84.7%
Percentage of test item with a thoracic particle size <10.0 μm - 2.07%
Percentage of test item with a respirable particle size <5.5 μm - 1.34%

Description of key information

Particle size data acquired for the test item is as follows:

Percentage of test item with an inhalable particle size <100 μm - 84.7%

Percentage of test item with a thoracic particle size <10.0 μm - 2.07%

Percentage of test item with a respirable particle size <5.5 μm - 1.34%