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Physical & Chemical properties

Melting point / freezing point

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Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 October - 21 December 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted in accordance with international guidelines and in acordance with GLP. All guideline validity criteria were met.
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
method to determine freezing temperature
Specific details on test material used for the study:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ca. 4 ºC in the dark and under nitrogen.
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: n/a
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: n/a

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: n/a
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: n/a
- Final preparation of a solid: n/a

FORM AS APPLIED IN THE TEST (if different from that of starting material): n/a

OTHER SPECIFICS: n/a
Key result
Melting / freezing pt.:
< -20 °C
Decomposition:
no
Sublimation:
no

Table 1       Cooling data (determination 1)

Time

(s)

Temperature

(ºC)

Time

(s)

Temperature

(ºC)

Time

(s)

Temperature

(ºC)

0

20.0

390

-1.5

780

-14.0

30

19.0

420

-2.5

810

-15.0

60

17.0

450

-4.0

840

-16.0

90

15.0

480

-5.0

870

-16.5

120

13.5

510

-6.0

900

-17.0

150

12.5

540

-7.5

930

-18.0

180

9.5

570

-8.5

960

-18.5

210

8.0

600

-9.0

990

-19.0

240

6.0

630

-10.0

1020

-19.5

270

4.5

660

-11.0

1050

-20.0

300

2.5

690

-12.0

1080

-20.5

330

1.0

720

-13.0

1110

-21.0

360

0.0

750

-13.5

1140

-21.5

Result: freezing temperature < -20 ºC

Table 2       Cooling data (determination 2)

Time

(s)

Temperature

(ºC)

Time

(s)

Temperature

(ºC)

Time

(s)

Temperature

(ºC)

0

20.5

390

-2.5

750

-15.0

30

19.5

420

-4.0

780

-16.0

60

17.5

450

-6.0

810

-16.5

90

14.0

480

-6.5

840

-17.5

120

11.0

510

-7.5

870

-18.0

150

10.0

540

-9.0

900

-18.5

180

8.0

570

-10.0

930

-19.5

210

7.5

600

-11.0

960

-20.0

240

5.5

630

-12.0

990

-20.0

270

4.0

660

-13.0

1020

-20.5

300

1.5

690

-13.5

1050

-21.0

330

0.5

720

-14.5

1080

-21.0

360

-1.0

 

Result: freezing temperature < -20 ºC

Conclusions:
The freezing temperature of the test item was < - 20 ºC.
Executive summary:

EU Method A.1 (2017) - An aliquot (approximately 15 mL) of test item was placed into a test tube containing a thermometer. A wire loop with which the sample could be agitated was placed inside the tube to ensure sample homogeneity during cooling. The test tube was surrounded by a glass jacket and then placed into a large beaker containing a dry ice/acetone mixture. The temperature and observations of the test item were recorded approximately every 30 seconds. The dry ice/acetone bath was maintained until the sample temperature had reached below -20 °C or until the test item solidified. The determination was carried out in duplicate.

The freezing temperature of the test item was established as being < - 20 ºC.

Description of key information

Melting Point = < - 20 ºC; EU Method A.1; Anon. (2017)

Key value for chemical safety assessment

Melting / freezing point at 101 325 Pa:
-20 °C

Additional information

In a study conducted in accordance with EU Method A.1, an aliquot (approximately 15 mL) of test item was placed into a test tube containing a thermometer. A wire loop with which the sample could be agitated was placed inside the tube to ensure sample homogeneity during cooling. The test tube was surrounded by a glass jacket and then placed into a large beaker containing a dry ice/acetone mixture. The temperature and observations of the test item were recorded approximately every 30 seconds. The dry ice/acetone bath was maintained until the sample temperature had reached below -20 °C or until the test item solidified. The determination was carried out in duplicate.

The freezing temperature of the test item was established as being < - 20 ºC.