Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. The substance is considered to be adequately characterised. Therefore full validation applies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.3 (Relative Density)
Deviations:
no
GLP compliance:
yes
Other quality assurance:
other: quality assurance statement
Type of method:
air comparison pycnometer (for solids)

Test material

Constituent 1
Reference substance name:
Rye, ext.
EC Number:
290-271-3
EC Name:
Rye, ext.
Cas Number:
90106-48-2
IUPAC Name:
Oligosaccharides and polysaccharides of glucose from Rye
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: white powder
- Storage In darkness at room temperature
- Batch: 16 167
- Manufacturing date: June 2016
- Expiry date: June 2018

Results and discussion

Density
Key result
Type:
relative density
Density:
>= 1.204 - <= 1.264 other: no unity
Temp.:
18.6 °C
Remarks on result:
other: A mean of the different measurements

Applicant's summary and conclusion

Conclusions:
The test substance is denser than water. The mean relative density of the test item, using the gas comparison method with the stereopycnometer, was 1.234 ± 0.030 at 18.6 °C ± 0.3 °C
Executive summary:

The density of the test substance was measured under GLP according to OECD 109 / EU A3 guideline, using gas comparison pycnometer method. After calibration, two independent samples were measured in triplicate.

The mean relative density of the test item, using the gas comparison method with the stereopycnometer, was 1.234 ± 0.030 at 18.6 °C ± 0.3 °C