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 is totally melted at 80°C, therefore no additional information is required.
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental Dates : 12-13. Feb. 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. The substance is considered to be adequately characterised. Therefore full validation applies.
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
27. July 1995
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
Commission Regulation (EC) No 440/2008 of 30 May 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Landesamt für Umwelt (inspected on 15-16/11/ 2017, signed on 15/05/2018)
Type of method:
differential scanning calorimetry
Specific details on test material used for the study:
Storage conditions: closed original container (metal bottle) under inert gas at 4 – 9 °C
Key result
Melting / freezing pt.:
ca. 25 - ca. 72 °C

Security Pre-test for the DSC instrument

The lid of the crucible was bloated and at the outside the crucible was contaminated with black-brown residue of the test item. The weight was recorded with 35.48 mg after reaching 420 °C. The crucible was opened the residue appeared slightly darker and smelled like a burnt candle. The second crucible was visual unchanged after reaching 100 °C. The weight was recorded with 36.43 mg.

DSC Measurement of the Test Item

In all three performed measurements no event could be detected in the cooling down phase.

In the heating up phase an endothermic behaviour was detected. This event can be identified as a melting range.

 Melting Range  Begin (°C)  End (°C)

 Peak 1

max* (°C)

 Peak 2

onset / max* (°C)

 Mass test item

 Mass crucible (before measurement) Mass crucible (after measurement)

 First determination (fresh sample)

 24.76

 71.54

 53.96

 50.36 / 64.75

 3.23 mg

 61.11 mg  61.09 mg

 Second determination (same sample as 1st det.)

 24.96

 70.07

  52.95

 49.16 / 64.28

 / (repetition)

 61.09 mg

 61.07 mg

The crucible was opened after measurement and the test item was visually unchanged.

 Third determination (fresh sample)

 26.39

 70.11

54.12

  52.19 / 63.80

 4.22 mg

 37.12 mg  37.11 mg

* Due to the shape of the endotherm, onset values could only be determined for the second peak.

As the detected melting peaks were wide and flat, with two discrete tops, and showed no sharp peak like the reference indium, it makes more sense to state a range then using the onset value.

For UVCB substances it is quite usual to have wide and flat peaks, and transition as a range is consistent with the chemical nature.

The retained result is the minimum and maximum of three independent determinations. However, it should be noted that these results may vary slightly with the substance composition.

Conclusions:
The substance is a low melting solid.
Executive summary:

The melting point of the test substance was determined, under GLP, according to OECD 102/EU A1 guideline, DSC method.

The substance was first cooled down to -65°C, to evaluate if the substance is a true solid, or a very viscous liquid. No event could be detected.

In the heating up phase, an endothermic behaviour was detected and attributed to melting. Wide and flat peak were recorded, with two discrete tops, so a melting range was retained, also consistent with the UVCB nature of the substance.

The melting range of the test item was determined to be between ca 25 and 72°C.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion