Registration Dossier

Administrative data

Endpoint:
density, other
Remarks:
density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 September - 17 December 2015
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
Qualifier:
according to
Guideline:
EPA OPPTS 830.7300 (Density / Relative Density / Bulk Density)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as stated in study reports): JNJ-4508530-AAA (T002707)
- Physical state: solid (powder)
- Appearance: white, beige powder
Specific details on test material used for the study:
Batch n°: I15BB0573
Analytical purity: > 97.0%
Expiration date: 08 February 2017
Storage condition: at room temperature

Results and discussion

Density
Key result
Type:
density
Density:
1.36 g/cm³
Temp.:
20 °C

Any other information on results incl. tables

The density (ρ) of a substance is the quotient of its mass and its volume and is expressed in SI units of kg/m³.

The individual measurements were obtained with an accuracy of <0.02 g/cm³.

The individual density measurements were 1.365 g/cm³ (test 1) and 1.357 g/cm³ (test 2).

Applicant's summary and conclusion

Conclusions:
A gas comparison stereopycnometer was used for the determination of the density of JNJ-4508530-AAA (T002707).
The density of the test item at 20ºC was 1.36 g/cm3.