Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
GLP compliance:
yes (incl. certificate)
Type of method:
capillary method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Batch/Lot number: 3300/004/A17
Appearance: White to yellowish powder
EC number: 272-296-1
CAS number: 68797-35-3
Chemical name: α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11- oxo-30-norolen-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
Purity: 95% (TIDS)
Expiry (Retest) date: 25 October 2019
Storage conditions: Protected from humidity at controlled room temperature
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.

Results and discussion

Melting / freezing point
Key result
Atm. press.:
ca. 101.325 kPa
Decomposition:
yes
Decomp. temp.:
ca. 265 °C
Remarks on result:
not determinable

Applicant's summary and conclusion

Executive summary:

The melting point study was performed according to the OECD 102 guideline.

Using a linear heating rate of 0.5°C/min, the test item was black by about 265°C (it can be considered as decomposition temperature) without melting. The test item appeared

to be charred. No melting point was observed, before the significant changes of consistency and colour of test item, which indicates degradation before the melting.

There was no melting point before degradation of test item (until approximately 265°C as estimated decomposition). Therefore, the melting point of test item was not interpretable.