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Solubility in organic solvents / fat solubility

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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

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

 

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.

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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