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Physical & Chemical properties

Particle size distribution (Granulometry)

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Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-04-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
A guideline study with GLP.
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 distribution:
mass based distribution
Specific details on test material used for the study:
L.A.E.
Appearance: White solid
Batch: 2625
Expiry date: April 2001
Purity: 92-94%
No.:
#1
Size:
> 400 µm
Distribution:
59 %
No.:
#2
Size:
125 - 400 µm
Distribution:
33.1 %
No.:
#3
Size:
75 - 125 µm
Distribution:
5.5 %
No.:
#4
Size:
30 - 75 µm
Distribution:
2.3 %
No.:
#5
Size:
10 - 30 µm
Distribution:
0.1 %
No.:
#6
Size:
< 10 µm
Distribution:
0 %

As 2.3% of the test material was less than 75 µm in diameter, image analysis was not performed.

Conclusions:
The result indicates that 0% by mass of Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) is smaller than 10 µm.
Executive summary:

The determination of particle size distribution of Nα-Lauroyl-L-arginine ethyl ester monohydrochloride was realized using sieve analysis:

Particle size (µm)

% by weight

>400

59.0

400-125

33.1

125-75  

5.5

75-30 

2.3

30 -10

0.1

<10

0

The results indicates that 0% by mass of LAE is smaller than 10 µm.

Description of key information

Key study: Test method OECD 110. GLP Study. The result indicates that 0% by mass of Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) is smaller than 10 micrometers.

Additional information

Key study 1: The determination of particle size distribution of Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) was realized using sieve analysis:

Particle size (µm)

% by weight

>400

59.0

400-125

33.1

125-75  

5.5

75-30 

2.3

30 -10

0.1

<10

0