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EC number: 642-902-2 | CAS number: 163802-53-7
- Life Cycle description
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- Appearance / physical state / colour
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Solubility in organic solvents / fat solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- solubility in organic solvents / fat solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-08 to 2012-11-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The homogeneity and stability of the test substance in corn was determined. Standards were made by diluting the test substance in hexanes and a calibration curve was constructed. Two solutions of the test article (1o mg/ml and 400 mg/ml) in corn oil were prepared. They were each sampled initially from the top, middle and bottom and analysed using GC/FID to determine the homogeneity of the test solution. Aliquots of the two solutions were taken at timed intervals and anlysed using GC-FID to determine their stability.
- GLP compliance:
- yes
- Key result
- Medium:
- standard fat
- Remarks:
- corn oil
- Solubility:
- 400 g/L
- Remarks on result:
- other: stable for 11 days
- Test substance stable:
- yes
- Conclusions:
- The solutions were determined to be stable for eleven days.
- Executive summary:
The object of this study was to determine the homogeneity and stability of the test article in com oil. Standards were made by diluting the test article in hexanes and constructing a calibration curve. Two solutions of the test article (10 mg/mL and 400 mg/mL) in com oil were prepared. They were each sampled initially from the top, middle, and bottom and analyzed via GC/FID to determine the homogeneity of the solution. The samples were determined to be homogeneous. Aliquots of the two solutions were taken at timed invervals and analyzed via GC/FID to detennine their stability. Both concentrations were determined to be stable for eleven days.
Reference
The results of the homogeneity analysis of the 10 mg/ml concentration test substance in corn oil solution are summarised in Table 1. The mean observed concentrations of the dosing solution prepared on 2012 -11 -08 were determined to be 9.42 ±0.40 mg/ml - top; 9.47 ±0.45 mg/ml - middle; 9.330 ±0.439 mg/ml-bottom. The relative standard deviation was 4.0%. The averages of all samples are shown in Table 2.
The results of the stability testing of the 10 mg/ml test substance in corn oil solution are summarised in Table 3. The solutions were determined to be stable for 11 days.
The results of the homogeneity analysis of the 400 mg/ml concentration of the test substance in corn oil solution are summarised in Table 1. The mean observed concentration of the dosing solution prepared on 2012 -11 -08 were determined to be 390.471 ± 10.427 mg/l - bottom; 408.65 ± 8.80 mg/ml - middle; 391.14 ± 6.22 mg/ml - top. The relative standard deviation was 2.9%. The averages of all the samples are shown in Table 2.
The results of the stability testing of the 400 mg/ml concentration of the test substance in corn oil solution are summarised in Table 3. The solutions were determined to be stable for 11 days.
Table 1: Homogeneity of test substance in corn oil solutions
Target concentration (mg/ml) |
Preparation date |
Aliquot ID |
Observed concentration (mg/ml)* |
Standard deviation |
Relative standard deviation (%) |
Percent of target (%) |
0 |
2012-11-08 |
Control corn oil |
Not detected (limit of detection 0.8 mg/ml) |
- |
- |
- |
10 |
2012-11-08 |
Top Middle Bottom |
9.423 9.470 9.330 |
0.395 0.448 0.439 |
4.2 4.7 4.7 |
94.2 94.1 92.7 |
400 |
2012-11-08 |
Top Middle Bottom |
391.140 408.652 390.471 |
6.221 8.804 10.427 |
1.6 2.2 2.7 |
97.7 102.1 97.5 |
|
|
|
|
|
|
|
*Determined form the mean observed concentration, n = 3
Table 2: Concentration summary of test substance in corn oil solutions
Target concentration (mg/ml) |
Mean observed concentration (mg/ml)* |
Standard deviation |
% RSD |
Percent of target (%) |
10 |
9.408 |
0.376 |
4.0 |
94.1 |
400 |
396.754 |
11.659 |
2.9 |
99.2 |
*Determined form the mean observed concentration, n = 3
Table 3: Stability of test substance in corn oil solutions
Sampling date |
Sample identifier |
Nominal concentration (mg/ml) |
Mean observed concentration (mg/ml)* |
Percent initial concentration (%) |
2012-11-08 |
Day 0 |
10 |
9.408* |
- |
2012-11-12 |
Day 4 |
10 |
9.164** |
91.6 |
2012-11-15 |
Day 7 |
10 |
9.794*** |
104.1 |
2012-11-19 |
Day 11 |
10 |
9.313*** |
99.0 |
2012-11-8 |
Day 0 |
400 |
394.745* |
- |
2012-11-12 |
Day 4 |
400 |
391.281* |
97.8 |
2012-11-15 |
Day 7 |
400 |
393.241*** |
99.1 |
2012-11-19 |
Day 11 |
400 |
383.282*** |
96.6 |
*Determined form the mean observed concentration, n = 3
**Determined from the mean of the mean observed concentration, n = 9
***Determined from the mean of the mean observed concentration, n = 6
Description of key information
Solubility in corn oil = stable for 11 days
Key value for chemical safety assessment
Additional information
The homogeneity and stability of the submission substance was determined in corn oil using two solutions with concentrations of 10 mg/ml and 400 mg/ml. Sampling was performed from top, middle and bottom and analysis was made by the use of GC-FID to determine the homogeneity of the test solution. The test samples were determined to be homogeneous. Furthermore, aliquots of the two solutions were taken at timed intervals and analysed using GC-FID to determine their stability. The test substance was determined to be stable for 11 days in the two concentrations.
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