Yucca schidigera, ext.

Boiling point

Administrative data

Endpoint:

boiling point

Data waiving:

study technically not feasible

Justification for data waiving:

the study does not need to be conducted because the substance is a solid which decomposes before boiling

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VII column 2, the study does i.a. not need to be conducted for substances which decompose before boiling (e.g. auto- oxidation, rearrangement, degradation, decomposition, etc.). There is a study according to OECD 102 and 103 available, using DSC measurements. In the relevant measurements, an endothermic event with sunken baseline afterwards was detected. Additionally an exothermic event in the endothermic event was detected during the second measurement. The endothermic event should be identified as melting under decomposition. This conclusion also includes the observations made in the pre-test. Here, melting with signs of decomposition was observed. As the substance is an UVCB, so the observation of a large and wide peak ranging over approx. 150 K is plausible and due to the nature of the test item. This is caused by the different components which are reacting in an individual way and hence possibly producing overlaying events.
Therefore the melting point is given in a range of: 112.57°C (385.72 K) to 262.70°C (535.85 K)
The determination of the boiling point of the test item Yucca schidigera, ext. is technically not feasible as the test item decomposed before boiling. Hence, boiling point determination can be omitted.

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:

2019-01-15 - -2019-03-26 (experimental phase: 2019-01-22 - 2019-02-06)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Version / remarks:

OECD Guideline for the Testing of Chemicals No. 102 dated 27. July 1995 “Melting Point / Melting Range“

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Version / remarks:

Commission Regulation (EC) No 440/2008 of 30 May 2008, published on 31. May 2008, Method A.1, “Melting/Freezing Temperature”

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: OECD TG 103

Version / remarks:

OECD Guideline for the Testing of Chemicals No. 103 “Boiling Point“, dated 27. Jul. 1995

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EU method A.2

Version / remarks:

Commission Regulation (EC) No 440/2008 of 30 May 2008, published on 31. May 2008, EU-Method A.2, “Boiling Temperature“

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany

Type of method:

differential scanning calorimetry

Specific details on test material used for the study:

The test item was stored in the test facility in a tightly closed vessel at room temperature (16.2 – 22.6 °C).

Key result

Melting / freezing pt.:

>= 112.57 - <= 262.7 °C

Decomposition:

yes

Remarks on result:

other: melting under decomposition

Conclusions:

The study was performed according to OECD TG 102/103 without deviations under GLP and therefore, the results can be considered as reliable.
Three DSC measurements were performed. In the first measurement no event could be detected, therefore a larger amount of the test item was weighted into the crucible and a second and third measurement was performed.
In the second and third measurement an endothermic event with sunken baseline afterwards was detected. Additionally an exothermic event in the endothermic event was detected during the second measurement. The endothermic event should be identified as melting under decomposition. This conclusion also includes the observations made in the pre-test. Here, melting with signs of decomposition was observed. As the substance is an UVCB, so the observation of a large and wide peak ranging over approx. 150 K is plausible and due to the nature of the test item. This is caused by the different components which are reacting in an individual way and hence possibly producing overlaying events.
Therefore the melting point is given in a range of: 112.57°C (385.72 K) to 262.70°C (535.85 K)
The determination of the boiling point of the test item Yucca schidigera, ext. is technically not feasible as the test item decomposed before boiling.

Executive summary:

The melting point and boiling point study was performed via DSC (differential scanning calorimetry) according to OECD TG 102 and 103 under GLP.

Three DSC measurements were performed. In the first measurement no event could be detected, therefore a larger amount of the test item was weighed into the crucible and a second and third measurement was performed.

In the second and third measurement an endothermic event with sunken baseline afterwards was detected. Additionally an exothermic event in the endothermic event was detected during the second measurement. The endothermic event should be identified as melting under decomposition.

Therefore the melting point under decomposition is given in a range of: 112.57°C (385.72 K) to 262.70°C (535.85 K)

The determination of the boiling point of the test item Yucca schidigera, ext. is technically not feasible as the test item decomposed before boiling.