Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

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
GLP compliance:
no
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Storage conditions: Room Temperature (20 ± 5 °C)
- Expiry date: 16. Dec. 2019

Results and discussion

Densityopen allclose all
Type:
density
Density:
1.111 g/cm³
Temp.:
20 °C
Type:
relative density
Density:
1.111 other: unitless
Temp.:
20 °C

Applicant's summary and conclusion

Conclusions:
The density of the test item has been determined to be 1.111 g/cm3 at 20 °C.
The study was performed according to the OECD TG109 and EU Method A.3 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1).
Executive summary:

The density of the test item was determined in a study according to OECD 109 resp. EU Method A.3 (pycnometer).

All procedures involving the pycnometer from wiping with the buckskin cloth to weighing were performed wearing cotton gloves. At all weighings, the corresponding temperature was recorded. All weighings were performed at 20.0 ± 0.2 °C. The determination was performed in duplicate.

The pycnometer was meticulously cleaned and dried. Pycnometer, test item, replacement liquid and water were tempered till room temperature. The test item was ground with mortar and pestle.

The pycnometer was rinsed with the ambient air, the outside was wiped with a clean buckskin cloth. After at least 10 minutes further standing, the dead weight was recorded (M1).

In order to determine the volume of the pycnometer, it was filled with water, wiped again and, after at least 10 minutes, weighed (M2).

The (cleaned) pycnometer was filled with replacement liquid, wiped again, and, after at least 10 minutes, weighed (M3). The pycnometer was then emptied, cleaned, and dried through rinsing with acetone and aeration with filtered air. Approx. 9 g of the ground test substance were filled into the pycnometer, the weight was recorded (M4). Then, replacement liquid was added to the mark and the pycnometer was weighed again (M5).

Before recording of the final weight, the pycnometer was set into an ultrasonic bath in order to remove any bubbles.

A density of 1.1110 ± 0.0011 g/cm3 at 20.0 ± 0.2 °C was measured. This value is the mean of two independent determinations with the maxi-mum error of a single determination. Standard deviation was 0.0011 g/cm3, showing good correlation of the two determinations. Therefore, the study is considered valid.