2-Hydroxypropyl-β-cyclodextrine ethers

Particle size distribution (Granulometry)

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of method:

sieving

Type of distribution:

mass based distribution

Test material

Test material information

Constituent 1

Reference substance name:

.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose

IUPAC Name:

.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose

Constituent 2

Reference substance name:

-

EC Number:

420-920-1

EC Name:

-

Cas Number:

128446-35-5

Molecular formula:

Hill formula: (C42H70-nO35)(C3H7O)n; n(mittel)=5,25

IUPAC Name:

5,10,15,25-tetrakis(hydroxymethyl)-40,44,47,49-tetrakis(2-hydroxypropoxy)-20,30,35-tris[(2-hydroxypropoxy)methyl]-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2³,⁶.2⁸,¹¹.2¹³,¹⁶.2¹⁸,²¹.2²³,²⁶.2²⁸,³¹]nonatetracontane-36,37,38,39,41,42,43,45,46,48-decol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Physical Appearance: white powder
Batch No.: 01 (DRD#: SIETS 96.010)
Purity: 89.16%
Water Solubility: >=180 g/L at 20 °C (SLI Report #97 -1 0-7113)
Density: 991 kg/m³ (0.991 g/cm³) at 24.9 °C (SLI Report #97-4-6948)
Storage conditions: room temperature in a dark, ventilated cabinet

Results and discussion

Particle size

Key result

Percentile:

D50

Remarks on result:

other: 0.0745 ± 0.0486 mm (length) by 0.0462 ± 0.0331 mm (width)(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

2 mm

Distribution:

> 0 %

Remarks on result:

other: Representative Particle Size Range: >2.0 mm

Particle size distribution at different passages 2

No.:

#2

Size:

1 mm

Distribution:

< 0.1 %

Remarks on result:

other: Representative Particle Size Range: 1.0-2.0 mm

Particle size distribution at different passages 3

No.:

#3

Size:

0.5 mm

Distribution:

0.4 %

Remarks on result:

other: Representative Particle Size Range: 0.500-1.0mm

Particle size distribution at different passages 4

No.:

#4

Size:

0.212 mm

Distribution:

10.7 %

Remarks on result:

other: Representative Particle Size Range: 0.212-0.500mm

Particle size distribution at different passages 5

No.:

#5

Size:

0.125 mm

Distribution:

23.7 %

Remarks on result:

other: Representative Particle Size Range: 0.125-0.212mm

Particle size distribution at different passages 6

No.:

#6

Size:

0.075 mm

Distribution:

25.3 %

Remarks on result:

other: Representative Particle Size Range: 0.075-0.125 mm

Particle size distribution at different passages 7

No.:

#7

Size:

0.063 mm

Distribution:

9.37 %

Remarks on result:

other: Representative Particle Size Range: 0.063-0.075 mm

Particle size distribution at different passages 8

No.:

#8

Size:

0.045 mm

Distribution:

11.7 %

Remarks on result:

other: Representative Particle Size Range: 0.045-0.063 mm

Particle size distribution at different passages 9

No.:

#9

Size:

other: basin

Distribution:

18.5 %

Remarks on result:

other: Representative Particle Size Range: fines

Any other information on results incl. tables

Microscopic Analysis:

A portion of the test substance was examined under a light microscopic using 40X magnification. The test substance appeared to be a fine, loose powder with no clumping. The test substance was observed to be white with a generally elongated shape. Using a graduated ocular lens, the length and width of 24 particles were measured. The mean ocular length, width and standard deviation (in millimeters) were calculated. The average particle size was calculated to be 0.0745 ± 0.0486 mm (length) by 0.0462 ± 0.0331 mm (width).

Sieve Analysis

Based on the particle size observed in the microscopic analysis, sieve sizes ranging from 2.0 to 0.045 mm were selected.

No hydroxypropylated .beta.-cyclodextrin was retained on the 2.0 -mm sieve. It is recommended in CIPAC Miscellaneous Technique (MT) 58 that personal protective equipment be worn when working with substances with a particle size distribution of this type.

Applicant's summary and conclusion

Executive summary:

This report describes the determination of the particle size of hydroxypropylated .beta.-cyclodextrinusing the dry sieve technique. Particle size between 2.0 to 0.045 mm was measured, and results are reported as the percent of particle retained on each sieve.

Information on the particle size distribution of a chemical in the environment is needed to assess its transport. Test substances with small particle sizes may easily penetrate through soils, whereas large particle sizes may affect the availability of the test substance to terrestrial and aquatic populations as well as affecting the potential biotic and abiotic degradation of the test substance.

The study was initiated on 7 April1997, the day the Study Director signed the protocol, and terminated on the day the Study Director signed the final report. The experimental phase of this study was conducted on 28 April1997 at Springborn Laboratories, Inc. (SLI), located in Wareham, Massachusetts. All original raw data and the final report produced during this study are stored in Springborn's archives at the above location.