Registration Dossier
Registration Dossier
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EC number: 627-199-2 | CAS number: 120728-10-1
Density
Administrative data
- Endpoint:
- relative density
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Aug 2020 to 25 Sep 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.3 (Relative Density)
- Version / remarks:
- March 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 109 (Density of Liquids and Solids)
- Version / remarks:
- October 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7300 (Density / Relative Density / Bulk Density)
- Version / remarks:
- June 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- air comparison pycnometer (for solids)
Test material
- Reference substance name:
- 1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid
- EC Number:
- 627-199-2
- Cas Number:
- 120728-10-1
- Molecular formula:
- C10H17NO4
- IUPAC Name:
- 1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- Physical state: powder
Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch number of test material: AC07N1912008
- Expiry date: 02 January 2021 (retest date)
- Physical Description: Almost white powder
- Purity: 98.9%
- Purity correction factor: no correction factor required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under storage conditions: not indicated
- Stability under test conditions: not applicable
- Solubility and stability of the test item in the solvent/vehicle: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: prior to use in the study, the test item was dried in a desiccator under vacuum using silicagel as the drying agent at 21.8 ± 3.3°C protected from light for 96 hours.
Results and discussion
Densityopen allclose all
- Key result
- Type:
- density
- Density:
- 1.19 g/cm³
- Temp.:
- 20 °C
- Remarks on result:
- other: The individual measurements were obtained with an accuracy of < 0.02 g/cm3. According to the guideline, the density of the test item is given as the mean value.
- Key result
- Type:
- relative density
- Density:
- 1.19
- Temp.:
- 20 °C
Applicant's summary and conclusion
- Conclusions:
- A gas comparison stereopycnometer was used for the determination of the density and relative density of JNJ-63543883-AAA (T003661).
The density of the test item at 20ºC was 1.19 g/cm3 (1.19E3 kg/m3). The relative density was 1.19
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