2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide

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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 117.6°C, therefore no additional information is required.

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental dates: 21-22 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to an internationally recognized method, and under GLP. No deviation was reported. The test substance is adequately characterised. Therefore full validation applies.

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Version / remarks:

1995

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Version / remarks:

Regulation (EC) No. 440/2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspection 20-21 June 2017, signed on 04 September 2017

Type of method:

differential scanning calorimetry

Specific details on test material used for the study:

Storage conditions: Ambient temperature (10 °C to 30 °C) in original glass bottle.
The sample was tested as received. No further preliminary treatment such as drying or milling was performed.

Key result

Melting / freezing pt.:

117.6 °C

Atm. press.:

1 013.3 hPa

Decomposition:

yes

Decomp. temp.:

>= 280 °C

The measurements showed an endothermal effect (melting) in the temperature range of 110 – 130 °C. The onset temperature was derived from the intersection of the tangent line with the highest slope of the endothermal peak with the baseline.

Test item / mg	Starting temperature / °C	Final test temperature / °C	Temperature range (endo-thermal) / °C	Onset (melting) / °C	Crucible	Observations after the measurement
15.26	25	500	110 –130	117.79	Aluminium with a hole	Test item discoloured to black Mass loss 73 %
12.49	25	200	110 – 130	117.39	Aluminium with a hole	Test item was a solidified melt

Duplicate measurements were within accuracy (±0.5 °C), therefore a mean value was calculated.

The test item had a mean melting point of 117.6 °C.

No endothermal effect was observed after melting occurred; decomposition took place starting at approximately 280°C (peak ca 350°C).

Executive summary:

The melting point of the test substance was determined under GLP according to OECD 102 / EU A1 guidelines, using Differential Scanning Calorimetry method.

The determination was carried out in aluminium pierced crucible, with a heating rate of 10 K/min, under nitrogen flow. Duplicate results were consistent, so the average value was retained.

The mean melting point was measured at 117.6°C.

Further heating led to decomposition, starting from 280°C.