Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
boiling point
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 103 (Boiling point/boiling range)
GLP compliance:
yes
Type of method:
other: Five methods for the determination of boiling point are described. These methods indude Ebuiiiometric method; Dynamic Method; Distillation Method; Siwoloboff Method; Photocell Detection 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%
Water Solubility: >=180 giL at 20 oc (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

Boiling point
Boiling pt.:
> 400 °C
Decomposition:
yes
Decomp. temp.:
400 °C

Applicant's summary and conclusion

Conclusions:
During this study, as the sample of hydroxypropylated .beta.-cyclodextrin was heated to approximately 200°C, moisture began to collect on the upper surface of the boiling flask. The test substance never melted. Above 300 °C, the sample began to cake-up and discolor (e.g. yellowing) on the bottom surface of the flask. At 400°C, the entire sample decomposed and turned brown. It was concluded that hydroxypropylated .beta.-cyclodextrin decomposed before boiling, even at reduced pressures of 1 torr. Testing was conducted at various pressures with no difference in the temperature of decomposition.
Executive summary:

Information on physical and chemical characterization of a test substance is required in support of product registration in OECD and EC countries. This report describes the boiling point ofhydroxypropylated .beta.-cyclodextrin. Boiling point is the temperature at which the equilibrium vapor pressure of a liquid equals the external atmospheric pressure. The boiling point provides information on the physical state of a substance in the environment, as solid, liquid, or gas as a function of temperature. This parameter helps to assess the movement and fate of the test substance in addition to human and environmental exposure to the substance.

The study was initiated on 7 April 1997, 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 from 18 to 21 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.