Registration Dossier

Administrative data

Endpoint:
relative density
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 109 (Density of Liquids and Solids)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7300 (Density / Relative Density / Bulk Density)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Type of method:
other: gas comparison pycnometer

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: 09 April 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

Density
Type:
relative density
Density:
1.01 g/cm³
Temp.:
20 °C
Remarks on result:
other: None

Any other information on results incl. tables

See appended PDF under 'Attached background material' for details on results

Applicant's summary and conclusion

Conclusions:
The relative density of the substance was found to be 1.010 at 20°C.

Executive summary:

The relative density of 12-hydroxystearic acid was determined using the gas comparison pycnometer method according to OECD Guideline 109, EU Method A.3 and EPA OPPTS 830.7300.

The volume of the reference and sample cells was determined using calibration balls. The density was determined by weighing the cells before and after filling with substance. The test procedure was repeated until a repeatability of <± 0.02 g/cm3 was reached. The determination of the relative density was performed by threefold measurements of two independent samples.

The relative density of the substance was found to be 1.010 at 20°C.