Registration Dossier
Registration Dossier
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EC number: 283-415-1 | CAS number: 84625-40-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Trigonella foenum-graecum, Leguminosae.
Density
Administrative data
Link to relevant study record(s)
- Endpoint:
- relative density
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 and 15 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was conducted according to an internationally recognised method. Test substance is adequately characterised. Therefore full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 109 (Density of Liquids and Solids)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.3 (Relative Density)
- Version / remarks:
- 2008
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected on 20 and 21 June 2017 / signed on 04 September 2017
- Type of method:
- pycnometer method
- Key result
- Type:
- relative density
- Density:
- 1.02 other: unitless
- Temp.:
- 20 °C
- Conclusions:
- The relative density of the test item at 20 °C (compared to water at 4 °C) according to the European Commission Regulation (EC) No. 440/2008 (A.3) and the OECD 109 guidelines, pycnometer method, was determined to be: D420 = 1.02 ± 0.01
- Executive summary:
The study was performed in order to determine the density of test item according to OECD 109, resp. EU A.3 guideline, using a pycnometer.
Reference
Relative density (glaspycnometer)
Two calibrations with water and two tests with test item using different pycnometers were carried out at a temperature of 20°C (see Table 4.4/1).
Table 4.4/1.- Relative density (glaspycnometer)
Pycnometer No. |
|
58 |
76 |
||||
Volume |
cm3 |
49.820 |
50.000 |
||||
Weight of empty pycnometer |
g |
36.7227 |
38.3207 |
||||
Weight of pycnometer filled with water |
g |
86.4477 |
88.2270 |
||||
Weight of water |
g |
49.7250 |
49.9063 |
||||
Relative density of water at 20 °CD420 |
- |
0.9981 |
0.9981 |
||||
Weight of empty pycnometer |
g |
36.7227 |
38.3207 |
||||
Weight of pycnometer filled with test item |
g |
87.3013 |
89.1254 |
||||
Weight of test item |
g |
50.5786 |
50.8047 |
||||
Relative Density at 20 °C D2020: |
- |
1.0151 |
1.0160 |
||||
Mean relative density at 20 °C D2020: |
1.02 ±0.01 |
||||||
Calibration of water and determinations of test item were within accuracy; therefore no additional measurement was needed, and the average value was given as final result.
Final results
The relative density of the test item at 20 °C (compared to water at 4 °C) according to the European Commission Regulation (EC) No. 440/2008 (A.3) and the OECD 109 guidelines, pycnometer method, was determined to be: D420=1.02 ±0.01
Description of key information
The relative density of the test item at 20 °C (compared to water at 4 °C) according to the European Commission Regulation (EC) No. 440/2008 (A.3) and the OECD 109 guidelines, pycnometer method, was determined to be: D420 = 1.02 ± 0.01
Key value for chemical safety assessment
- Relative density at 20C:
- 1.02
Additional information
A fully reliable experimental study, conducted according to OECD 109/ EU A3 guideline is available.
It is considered as a key study, and the result is retained as key data.
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