Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
Yucca schidigera, ext.
EC Number:
607-033-5
Cas Number:
223749-05-1
IUPAC Name:
Yucca schidigera, ext.
Test material form:
solid: particulate/powder
Remarks:
fine beige
Details on test material:
Storage: Room Temperature (20 ± 5 °C)
Homogeneity: homogeneous
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).

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
>= 112.57 - <= 262.7 °C
Decomposition:
yes
Remarks on result:
other: melting under decomposition

Applicant's summary and conclusion

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.