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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 May 2012 - 03 September 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Experimental study conducted in GLP compliant lab according to EC and OECD test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate
EC Number:
700-792-4
Molecular formula:
C26H51NO2, C28H55NO2
IUPAC Name:
Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate
Test material form:
other: white to pale yellow solid
Details on test material:
- Name of test material (as cited in study report): T-1640L
- Physical state: white to pale yellow solid
- Analytical purity: 98.74%
- Purity test date:
- Lot/batch No.: 10121
- Expiration date of the lot/batch: 12 April 2013
- Stability under test conditions: stable
- Storage condition of test material: refrigerated in the dark under dry conditions

Results and discussion

Water solubility
Water solubility:
< 0.05 mg/L
Temp.:
20 °C
pH:
>= 6.4 - <= 7
Details on results:
The detector calibration was found to be linear over the range 0 to 5 mg/l of standard
solutions in chloroform with a regression coefficient of 0.9981.
A summary of the results of the test and shows that the water solubility of
T-1640L is less than 0.05 mg/l. The primary data for this test is also presented.
A mean recovery of approximately 117% of T-1640L from fortified control samples was
achieved and deemed to be acceptable at the low solubility level, whilst no significant
interfering peaks were evident in blank control solutions.

Applicant's summary and conclusion

Conclusions:
T-1640L was found to have a water solubility of less than 0.05 mg/l at 20°C.