N-(1-oxooctyl)glycine

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February to June 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

sedimentation (gravitational settling)

Type of distribution:

other: gravitational liquid sedimentation methods – Part 2: Fixed pipette method”, vom 15. Apr.2001

Test material

Test material information

Constituent 1

Reference substance name:

N-(1-oxooctyl)glycine

EC Number:

238-122-3

EC Name:

N-(1-oxooctyl)glycine

Cas Number:

14246-53-8

Molecular formula:

C10H19NO3

IUPAC Name:

N-(1-oxooctyl)glycine

Details on test material:

Name LCA07012
Batch 716300006
Appearance white powder
Composition N-n-octanoyl amino acetic acid
Molecular formula C10H19NO3
Molecular weight 201.3 g/Mol
Purity 99 %
Homogeneity homogeneous
Solubility H2O 1g/L; acetone, CH3CN unknown
Production date 30. Jun. 2007
Expiry date 11. Jun. 2010
Storage room temperature (20 ± 5 °C)
Hazard information none
R-phrases R36/38: Irritating to eyes and skin.
S-phrases none
Note: Water solubility of the test item was determined with 1.55 g/L in a separate study
(07080601G910). Density was determined within this study with 1.1233 g/mL.
Storage
The test item was stored in a closed vessel dry at room temperature

Results and discussion

Particle size

Particle size 1

Percentile:

D50

Mean:

> 57.64 µm

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size 2

Percentile:

D50

Mean:

> 84 µm

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size 3

Percentile:

D10

Mean:

> 32 µm

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Any other information on results incl. tables

All measured values show good reproducibility, giving deviations of less than 20%. Variations were observed when measuring at sampling times below 2 minutes. At the highest Stokes diameter which was measured within this study (167 μm in the pre-test), a lower residue than at the next lower size (104 μm, pre-test) was found. At particle size 80 μm and lower, correlation was very good, though. From the measured values, it can be assumed, that approx. 30% of the particles are larger than 100 μm. No particles smaller than 10 μm were detected, therefore, it can be assumed that the inhalative toxicity doesn’t have to be tested. The result of the test can be considered valid.

Applicant's summary and conclusion

Executive summary:

The particle distribution of LCA07012 was determined by sedimentation following ISO 13317-2 – Fixed Pipette Method For the test item LCA07012, the following particle size distribution was found in two independent studies:

Experiment 1		Experiment 2
Stokes-diameter in μm	% mass under particle size	Stokes-diameter in μm	% mass under particle size
82.37	82.37%	84.26	53.45%
57.64	40.74%	58.69	39.66%
46.56	29.88%	47.56	29.31%
39.78	22.96%	40.54	22.41%
35.09	15.56%	35.68	13.55%
31.39	11.60%	32.12	10.59%
28.54	5.19%	29.14	3.20%
26.20	3.70%	26.69	2.22%
24.22	0.74%	24.78	0.00%
22.52	0.74%	23.13	1.23%

The determination was performed in duplicate, using H2O, saturated with the test item and with a very low concentration of detergent (Synperonic PE/L 101) as suspending medium.