Registration Dossier

Diss Factsheets

Physical & Chemical properties

Melting point / freezing point

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 Aug - 21 Sep 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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: Room temperature in the dark 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

Cooling data for Determinations 1 and 2 are shown in the Table 1 and Table 2.

Table 1: Determination 1

Time (s)

Temperature (°C)

Time (s)

Temperature (°C)

Time (s)

Temperature (°C)

0

22.5

480

-4.0

930

-16.5

30

20.5

510

-5.0

960

-17.0

60

19.0

540

-6.0

990

-17.5

90

16.5

570

-7.0

1020

-17.5

120

14.5

600

-8.0

1050

-18.0

150

12.5

630

-9.0

1080

-18.5

180

10.5

660

-10.0

1110

-19.0

210

9.0

690

-11.0

1140

-19.5

240

8.0

720

-12.0

1170

-20.0

270

6.5

750

-12.5

1200

-20.0

300

4.5

780

-13.0

1230

-20.0

330

3.0

810

-14.0

1260

-20.5

360

1.5

840

-14.5

1290

-20.5

390

0.0

870

-15.0

1320

-20.5

420

-1.5

900

-16.0

1350

-21.0

450

-2.5

 

Observations: The tet item did not freeze during cooling.

Table 2: Determination 2

Time (s)

Temperature (°C)

Time (s)

Temperature (°C)

Time (s)

Temperature (°C)

0

22.0

510

-6.0

1020

-17.0

30

19.5

540

-7.0

1050

-17.5

60

17.0

570

-8.0

1080

-17.5

90

15.0

600

-9.0

1110

-18.0

120

13.0

630

-9.5

1140

-18.5

150

11.0

660

-10.5

1170

-19.0

180

9.0

690

-11.5

1200

-19.5

210

7.0

720

-12.0

1230

-19.5

240

5.5

750

-12.5

1260

-20.0

270

4.0

780

-13.0

1290

-20.0

300

2.5

810

-13.5

1320

-20.5

330

1.0

840

-14.0

1350

-20.5

360

-0.5

870

-14.5

1380

-20.5

390

-1.5

900

-15.0

1410

-21.0

420

-3.0

930

-15.5

1440

-21.0

450

-4.0

960

-16.0

 

480

-5.0

990

-16.5

 

Observations: The test item did not freeze during cooling.

Overall result: Freezing point <-20 ± 0.5˚C (<253 ± 0.5 K)

Conclusions:
The melting point/ freezing point of the substance has been determined to be <-20 ± 0.5˚C (<253 ± 0.5 K).
Executive summary:

The melting point/ freezing point was determined using a technique designed to be compatible with Method EU A.1 and OECD 102. The freezing point of the substance was observed to be < 21˚C on two occassions.

The melting point/ freezing point of the substance has been determined to be <-20 ± 0.5˚C (<253 ± 0.5 K).

Description of key information

EU Method A.1, 2017 - The melting point/ freezing point was determined using a technique designed to be compatible with Method EU A.1 and OECD 102. The freezing point of the substance was observed to be < 21˚C on two occassions.

The melting point/ freezing point of the substance has been determined to be <-20 ± 0.5˚C (<253 ± 0.5 K).

Key value for chemical safety assessment

Additional information