Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
water solubility
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 105 (Water Solubility)
GLP compliance:
yes
Type of method:
flask method

Test material

Constituent 1
Reference substance name:
.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
IUPAC Name:
.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
Constituent 2
Chemical structure
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:
2-Hydroxypropyl-.beta.-cyclodextrine ethers
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%
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

Water solubility
Water solubility:
>= 180 g/L
Temp.:
20 °C
pH:
> 1 - < 10
Details on results:
Based on the results, it was determined that the water solubility of hydroxypropylated .beta.-cyclodextrin was greater than or equal to 180 g/L at room temperature in the pH range of 1 to 10. The measured pH for the pH 1, 7, and 10 samples were 1.00, 7.08, and 9.77 in a representative sample at each pH. The density of the test solutions at all three pH values was 1.05 g/ml. Analysis of the QC samples prepared at Springborn (n=3) resulted in recoveries that ranged from 102 to 112% of nominal.
Analysis of the QC samples prepared by Midwest Research Institute (n=6), resulted in recoveries which ranged from 87.4 to 106% of nominal.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
It can be concluded that the water solubility of hydroxypropylated .beta.-cyclodextrin is greater than or equal to 180 g/L at room temperature (20 °C) in the pH range of 1 to 10.
Executive summary:

Information on physical and chemical characteristics is required to support registration of products in OECD, European Union countries, and Canada. This report describes the determination of the solubility of hydroxypropylated .beta.-cyclodextrin in buffered water at pH 1, 7 and 10. The solubility of a solid or liquid chemical can be defined as the maximum amount of the chemical (the solute) in solution and at equilibrium with excess chemical in a solvent at specified ambient conditions (temperature, atmospheric pressure, and pH). Water solubility is an important property governing the mobility and distribution of a chemical within the environment. Generally, highly water soluble chemicals are more likely to be transported and distributed by the hydrologic cycle than relatively water-insoluble chemicals. The degree of water solubility influences the extent to which a chemical may sorb to particulate matter or cross a lipid/water interface. The water solubility of a substance is specified by the saturation mass concentration of the substance in water and is a function of temperature. Knowledge of a chemical's water solubility is also used to determine appropriate experimental design in ecological fate and effects tests.

The study was initiated on 8 April 1997, the day the Study Director signed the protocol, and was completed on the day the Study Director signed the final report. The experimental phase of this study was conducted from 11 to 21 May 1997, at Springborn Laboratories, Inc. (SLI), located in Wareham, Massachusetts.