Methyl L-threoninate

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-03-19 to 2013-11-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: L-TME was assessed using particle size apparatus based on laser diffraction

Deviations:

not applicable

Principles of method if other than guideline:

The size distribution of particles was assessed using particle size apparatus based on laser diffraction

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

mass based distribution

Test material

Test material information

Constituent 1

Reference substance name:

Methyl L-threoninate

EC Number:

222-158-1

EC Name:

Methyl L-threoninate

Cas Number:

3373-59-9

Molecular formula:

C5H11NO3

IUPAC Name:

Methyl (2S,3R)-2-amino-3-hydroxy-butanoate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): L-threonine methyl ester
- Physical state: white crystalline powder
- Analytical purity: 99.8%

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: X5UYC99
- Expiration date of the lot/batch: July2014
- Purity test date: 99.8 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Frozen (ca. -20 ̊C)

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Preparation of a nanomaterial dispersion (incl. dilution):
A saturated solution of L-threonine methyl esterin heavydistillate of petroleum
The bulk container of test substance was inverted 10 times and a portion (500 mg) transferred to a vial. The entire contents of the vial were added directly to the sampling tank containing dispersant.

Results and discussion

Mass median aerodynamic diameter:

252 µm

Geometric standard deviation:

0

Remarks on result:

other: L-TME was determined to have d(0.1), d(0.5) and d(0.9) values of 63, 251 and 661 μm respectively. The Mass Median Diameter was determined to be 251 µm. No information on standard deviation.

Particle size

Particle size 1

Key result

Percentile:

D10

Mean:

63 µm

Remarks on result:

other: No information for Standard deviation.

Particle size 2

Key result

Percentile:

D50

Mean:

251 µm

Remarks on result:

other: No information for Standard deviation.

Particle size 3

Key result

Percentile:

D90

Mean:

661 µm

Remarks on result:

other: No information for Standard deviation.

Any other information on results incl. tables

L-TME was determined to have d(0.1), d(0.5) and d(0.9) values of 63, 251 and 661 μm respectively.

Applicant's summary and conclusion

Conclusions:

The particle size distribution of L-TME was determined to have d(0.1), d(0.5) and d(0.9) values of 63, 251 and 661 μm respectively.

Executive summary:

The size distribution of particles present in L-TME was assessed using particle size apparatus based on laser diffraction. L-TME was determined to have d(0.1), d(0.5) and d(0.9) values of 63, 251 and 661 μm respectively. The Mass Median Diameter was determined to be 251 µm