Registration Dossier

Administrative data

Endpoint:
density, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was carried out on the 26 July 2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The density of the substance was determined using a Micromeritics Accu Pyc 1330 He-gas pycnometer.
- Principle of test: Determination of the bulk density of the test material at room temperature
- Short description of test conditions: The test material was determined using a Micromeritics Accu Pyc 1330 He-gas pycnometer.
The test material had the following purity:
all-trans-β-carotene: 89.6%
Β-carotene: 98.2% (Σ cis + trans)
GLP compliance:
not specified
Type of method:
pycnometer method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ß-Carotene crystalline
- Physical state: crystalline solid
- Analytical purity: 97.77%
- Lot/batch No.: WC00504271
- Expiration date of the lot/batch: July 2007 (in an unopened ampoule)
- Stability under test conditions: Light-sensitive
- Storage condition of test material: At room temperature in the unopened ampoule; in the freezer under argon when not stored in the ampoule. As the test item is light-sensitive, all test item handling was performed under red light.

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
ß-Carotene d = 1.001 ± 0.002 g/cm3