Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Aug. 17, 2010 to Sept. 29, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to standard guidelines in compliance with GLP.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
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
Qualifier:
according to
Guideline:
EPA OPPTS 830.7200 (Melting Point / Melting Range)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Type of method:
capillary method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 12-hydroxystearic acid
- Physical state: Solid / white to yellowish
- Certificate of analysis date: April 09, 2010
- Expiration date of the lot/batch: 09 April 2011
- Storage condition of test material: In original container, at room temperature (15 - 25°C), in the dark

Results and discussion

Melting / freezing point
Melting / freezing pt.:
75 - 78 °C
Atm. press.:
ca. 1 atm
Decomposition:
no
Remarks on result:
other: The melting started at 75.2 °C. At 78.0 °C the final stage of melting was reached. No solid particles were left.

Any other information on results incl. tables

Table 1. Results for the determination of the melting range of 12-hydroxystearic acid

Experiment No. Stage A [°C] Stage B [°C] Stage C [°C] Stage D [°C] Stage E [°C]
1 75.2 75.8 76.5 77 78.1
2 75.1 76 76.7 77.4 77.8
3 75.4 76.2 76.8 77.2 78.1
mean value (n=3): 75.2°C 76.0°C 76.7°C 77.2°C 78.0°C
  348.4 K 349.2 K 349.8 K 350.4 K 351.2 K

Stage A: Beginning of melting / wet point

Stage B: Shrinking point

Stage C: Collapse point

Stage D: Liquefying point

Stage E: Final stage of melting

Applicant's summary and conclusion

Conclusions:
The melting point of test substance was found to be in the range of 75 to 78°C.

Executive summary:

The melting point of 12-hydroxystearic acid was determined by the capillary method using an electronically-controlled heating system according to OECD Guideline 102, EU Method A.1 and EPA OPPTS 830.7200.

In the preliminary test, a sample of the test material in a capillary glass tube was heated from room temperature with a rate of approximately 10ºC/min. to estimate phase transition temperature. For the actual determination of the melting point, the temperature rise was adjusted to a maximum of 1ºC/min. at about 15 ºC before and after the predetermined phase transition temperature.

The melting point of the test substance was found to be in the range of 75 to 78°C.