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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 March 2018 - 9 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
July 27, 1995
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method

Test material

Constituent 1
Chemical structure
Reference substance name:
Octadecyl docosanoate
EC Number:
246-115-1
EC Name:
Octadecyl docosanoate
Cas Number:
24271-12-3
Molecular formula:
C40H80O2
IUPAC Name:
octadecyl docosanoate
Specific details on test material used for the study:
IR spectrum of test item after the completion of experiment was the same as that before the start of experiment, and it indicated that the test item was stable under the storage conditions

Results and discussion

Water solubility
Key result
Water solubility:
< 0.005 mg/L
Temp.:
20 °C
pH:
ca. 6
Remarks on result:
other: below the limit of quantification

Any other information on results incl. tables

Calibration curve of the test item

Concentration

(mg/L)

Peak area

(fA*sec)

0.0502

2515

0.251

14214

0.502

30050

1.00

58770

 

y = 58860 * x

r = 1.0

 

 

Calculation of water solubility

Sample description

A

B

Standard solution 0.502 mg/L µg/L

30838

 

Fraction 1

n.d.

<0.00502

Fraction 2

n.d.

<0.00502

 

A: Peak area

- A(standard): Standard solution

- A(sample): Sample

B: Concentration of test item (mg/L)

- B = (C * A(sample) / A(standard) * D /1000)/ E*1000

C: Concentration of test item in standard solution - 0.502 (mg/L)

D: Final volume (2 mL)

E: Sampling volume (20 mL)

The pH measured for Fractions 1 and 2 was 6.0.

Water solubility

Water solubility of test item <0.00502 mg/L (20ºC)

Discussion

The water solubility was lower than the concentration calculated from the limit of quantification.

However, the method of determination was judged to be valid considering the results of linearity (calibration curve) and recovery test. Therefore, it was concluded that the test results were acceptable.

Applicant's summary and conclusion