Registration Dossier

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 June 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
appearance / physical state / colour
Type of information:
other: Visual inspection
Adequacy of study:
weight of evidence
Study period:
10 June 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Visual inspection upon receipt in the laboratory.
GLP compliance:
yes (incl. certificate)
Physical state at 20°C and 1013 hPa:
solid
Form:
solid: particulate/powder
Colour:
pink
Odour:
other: no data
Substance type:
inorganic
Conclusions:
Upon receipt in the laboratory, the test material used for the physicochemical property testing was described as a pink powder.

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: PEGYZ-23
- Expiration date of the lot/batch: 31 March 2021
- Purity: 100%

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

OTHER SPECIFICS
Description: pink powder (the colour was determined by visual inspection upon arrival at test facility)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personal health and safety. Possibly irritative.

Results and discussion

Density
Key result
Type:
relative density
Density:
5.985
Temp.:
20.5 °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. Note that Assay No. 1 was not taken into account, as the pressure values obtained were not stable and not reliable.

Assay No. 2:

Test item sample weight: 17.6691 g

Reference volume: 79.250 cm³

Volume of the sample holder: 27.636 cm³

Temperature during the assay: 20.7°C

 Data

 P2

(PSIG)

 P3

(PSIG)

 VP

(cm³)

 Density

(g/cm³)

 Relative

density

 Mean relative

density

 Run no. 6  17.039  4.047  2.9497  5.9902  5.9903       5.987 ± 0.005
 Run no. 6  17.035  4.046  2.9501  5.9894  5.9895
 Run no. 7

 17.037

 4.046  2.9539  5.9817  5.9818

Runs 1-5 were not taken into account because they did not comply with the quality criterion.

The relative density of the test item in assay No. 2 was 5.987 ± 0.005 at 20.7 °C.

Assay No. 3

Test item sample weight: 17.4810 g

Reference volume: 79.250 cm³

Volume of the sample holder: 27.636 cm³

Temperature during the assay: 20.3°C

 Data

 P2

(PSIG)

 P3

(PSIG)

 VP

(cm³)

 Density

(g/cm³)

 Relative

density

 Mean relative

density

 Run no. 3  17.248  4.100  2.9231  5.9803  5.9804      5.983 ± 0.002
 Run no. 4  17.104  4.066  2.9213  5.9840  5.9842
 Run no. 5

 17.024

 4.047  2.9211  5.9843  5.9845

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

The relative density of the test item in assay No. 3 was 5.983 ± 0.002 at 20.3 °C.

Based on the results of assay No. 2 and 3, the mean relative density was calculated to be 5.985 +/- 0.004 at 20.5°C.

Applicant's summary and conclusion

Conclusions:
The mean relative density of the test item was determined to be 5.985 ± 0.004 at 20.5°C.