Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 May 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
OECD Guideline 109 (Density of Liquids and Solids)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.3 (Relative Density)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
air comparison pycnometer (for solids)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SZ-380-STM-16
- Expiration date of the lot/batch: 04 March 2017
- Purity: > 98%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions of test material: room temperature (15-25 ºC, below 70% relative humidity), protected from light and humidity

OTHER SPECIFICS:
- Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personal health and safety.

Results and discussion

Density
Key result
Type:
relative density
Density:
5.316
Temp.:
19.75 °C
Remarks on result:
other: Mean relative density and mean temperature based on 2 assays.

Any other information on results incl. tables

Detailed results of the two assays are given below:

Assay No. 1:

Test item sample weight: 8.3527 g

Reference volume: 79.250 cm³

Volume of the sample holder: 27.636 cm³

Temperature during the assay: 20.2°C

 Data

 P2

(PSIG)

 P3

(PSIG)

 VP

(cm³)

 Density

(g/cm³)

 Relative

density

 Mean relative

density

 Run no. 5  17.558  4.345  1.575  5.303  5.303       5.304  ± 0.002
 Run no. 6  17.388  4.303  1.575  5.304  5.305
 Run no. 7

 17.210

 4.259  1.574  5.306  5.306

Runs 1-4 were not taken into account because they did not comply with the quality criterion.

The relative density of the test item based on assay no. 1 was 5.304 ± 0.002 at 20.2°C.

Assay No. 2:

Test item sample weight: 8.4749 g

Reference volume: 79.250 cm³

Volume of the sample holder: 27.636 cm³

Temperature during the assay: 19.3°C

 Data

 P2

(PSIG)

 P3

(PSIG)

 VP

(cm³)

 Density

(g/cm³)

 Relative

density

 Mean relative

density

 Run no. 3  17.113  4.233  1.591  5.328  5.328       5.328  ± 0.001
 Run no. 4  17.190  4.252  1.591  5.327  5.327
 Run no. 5

 17.117

 4.234  1.590  5.329  5.329

Runs 1-2 were not taken into account because they did not comply with the quality criterion.

The relative density of the test item based on assay no. 1 was 5.328 ± 0.001 at 19.3°C.

Applicant's summary and conclusion

Conclusions:
The mean relative density of the test item was determined to be 5.316 ± 0.013 at 19.8°C.