Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
relative self-ignition temperature (solids)
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:
EU Method A.16 (Relative Self-Ignition Temperature for Solids)
GLP compliance:
yes

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 g/L at 20 °C (SLI Report #97-10-7113)
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

Relative self-ignition temperature (solids)
Relative self-ignition temperature:
> 400 °C
Remarks on result:
no self ignition observed under the test conditions
Remarks:
at atm. press. of 1013.0 hPa

Any other information on results incl. tables

During this study, the test substance heating rate was calculated to be 21 °C/hour.

Hydroxypropylated .beta.-cyclodextrin did not self-ignite, therefore, the auto-flammability is reported to be greater than 400 °C.

However, the sample did appear to decompose to a black foam/ash-like residue. This decomposition was confirmed in the boiling point experiment with hydroxypropylated .beta.-cyclodextrin (SLI Report #97 -5 -6964), where the test substance began to decompose at 300 °C and completely decomposed at 400 °C.

Applicant's summary and conclusion

Conclusions:
Hydroxypropylated .beta.-cyclodextrin did not self-ignite during this experiment. The sample appeared to decompose to a black foam/ash-like residue. Therefore, the auto-flammability of sample hydroxypropylated .beta.-cyclodextrin is reported to be greater than 400 °C.
Executive summary:

Autoignition or auto-flammability is defined as the minimum temperature at which a certain amount of substance will produce a hot flame without the aid of an external flame or spark. Selfignition occurs when the rate of heat produced through oxidation processes, commonly in air, exceeds the heat loss to the surroundings. When the net energy increase reaches a characteristic point, spontaneous combustion occurs. This process of self-ignition is also referred to as autoignition, auto-flammability or by the acronyms AIT (autoignition temperature) or SIT (self-ignition temperature).

Autoignition is dependent on the chemical and physical properties of the test substance and the method and apparatus used to determine it. The volume of the vessel used to determine the auto ignition temperature is important, as lower autoignition temperatures will occur in vessels of larger volume. The vessel substance can also be important. Environmental conditions under which the experiment is performed may also affect the autoignition temperature. Therefore, the autoignition temperature determined by a particular method is not necessarily the minimum temperature at which a substance will self-ignite in air. In view of the complex nature of the ignition and combustion of substances, the self-ignition temperature of the test substance determined by this method should be used for comparison purposes only.

The study was initiated on 1 May 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 1 to 13 May 1997 at Springborn Laboratories, Inc. (SLI), located in Wareham, Massachusetts.