Registration Dossier

Administrative data

Endpoint:
flash point of flammable liquids
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids
the study does not need to be conducted because decomposition occurred during the melting point study
Cross-referenceopen allclose all
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December, 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Appearance based on observations from other testing endpoints conducted for this substance
Reason / purpose:
reference to other study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
Observations based on the observations made during testing for other endpoints
Physical state at 20°C and 1013 hPa:
solid
Key result
Form:
solid: pellets
Remarks:
white waxy solid pellets or white pastilles
Colour:
White
Substance type:
organic
Conclusions:
The substance was identified to be white waxy solid pellets or pastilles.
Executive summary:

The physical state and appearance of the test substance, 'mono- and di- C16 PSE, K+ and C16-OH and isostearyl isostearate', were visually observed during testing of other endpoints. The purified form of the test substance is a white waxy solid pellets or pastilles (XCellR8, 2019).

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
boiling point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 19 December 2018 to 22 February 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 103 (Boiling Point)
Deviations:
not specified
GLP compliance:
no
Remarks:
The study was conducted in a facility which operates in accordance with Good Laboratory Practice principles; however no claim of GLP compliance was intended nor is made for this study
Type of method:
differential scanning calorimetry
Key result
Atm. press.:
ca. 100 kPa
Decomposition:
yes
Decomp. temp.:
>= 280 °C
Remarks on result:
other: decomposition before boiling

Results

For the thermograms and thermographic data for Determinations 1 and 2, kindly refer the attached background material section of the IUCLID.

Thermographic Data

Thermal Event

Interpretation

Temperature (°C)

Determination 1

Determination 2

Exotherm

Onset of decomposition

279.55

281.00

Atmospheric pressure:  100 kPa

After heating to 400 °C, the samples had lost approximately 88% and 81% of their original weight for Determinations 1 and 2 respectively.

Boiling temperature: decomposition from approximately 280 °C (553 K)

Discussion

The test substance softened gradually over a broad temperature range with apparently 3 or 4 observable phases in the thermograms. This may have been due to not only the test substance being a mixture of components, but also components having different organic functional groups. Therefore, each component or group of components could have their own melting temperature resulting in the test substance not completely melting until 121 °C. This effect resulted in the test substance gradually softening rather than a sudden complete melt over a short temperature range. As a result of the low rate of enthalpy change during decomposition, the onset temperature could only be approximated.

Conclusion

The test substance has been determined to decompose from approximately 280 °C (553 K) at 100 kPa. As the test substance decomposed, no value for boiling temperature could be determined.

Conclusions:
Under the study conditions, the test substance has been determined to decompose from approximately 280°C at 100 kPa. As the test substance decomposed, no value for boiling temperature could be determined.

Executive summary:

A study was conducted to determine the boiling point of test substance using the differential scanning calorimetry method, according to OECD Guideline 103. Under the study conditions, the test substance has been determined to decompose from approximately 280°C at 100 kPa. As the test substance decomposed, no value for boiling temperature could be determined (Envigo, 2019).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion