Registration Dossier

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a solid having a melting point <= 160°C
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACh Annex VII, the study does not need to be conducted for solids, if the substance has a melting point ≤ 160 °C, or if preliminary results exclude self-heating of the substance up to 400 °C.
As presented under IUCLID Section 4.2, the substance has a melting point of ca 79°C, therefore no additional information is required.
For the same reason, self-heating does not apply, and self-heating, under IU section 4.13, is recommended by ECHA R7a guidance (v6.0, July 2017, §R7.1.10.7), instead of relative self-ignition of solids based on EU A16 guideline under the present IU section 4.12, because the new UN N4 test is the standard used for CLP classification purpose.
Therefore, the experimental study (A16) was deemed unnecessary.
Cross-referenceopen allclose all
Reason / purpose:
data waiving: supporting information
Reference

Melting range : 78 - 80°C (from literature)

Melting / freezing point at 101 325 Pa:
79 °C

No experimental study is available. However, a melting range is cited in an opinion from scientific authority, therefore considered as reliable information. The average value is retained as key data.

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
self-heating substances / mixtures
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is completely molten at 160°C
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to the Guidance on the Application of the CLP Criteria (v5.0, July 2017, §2.11.4.2.):
"the phenomenon of self-heating applies only to solids. The surface of liquids is not large enough for reaction with air, and the test method (UN N4) is not applicable to liquids. Therefore, liquids are not classified as self-heating…
(similarly) substances or mixtures with a low melting point (< 160 °C) should not be considered for classification in this class (either) since the melting process is endothermic and the substance-air surface is drastically reduced. However, this criterion is only applicable if the substance or mixture is completely molten up to this temperature."
Considering that the test item has a melting point of ca 79°C (see IU Section 4.2) the test is considered as NOT necessary.
Moreover, the chemical structure does not contain metals or metalloïds, which are typically self-heating substances.
Reason / purpose:
data waiving: supporting information

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion