Registration Dossier

Physical & Chemical properties

Water solubility

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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Ethyl Ascorbic acid
Physical state: White to very pale yellow crystalline powder
Test item storage: In freezer (≤ -15°C) desiccated
Stability: Stable under storage conditions until 21 April 2018 (retest date)

Results and discussion

Water solubility
Water solubility:
>= 1 000 <= g/L
Temp.:
20 °C
pH:
>= 2.1 - <= 2.2

Any other information on results incl. tables

Results

Preliminary test

The content of test item dissolved in water was estimated to be 124 g/l during the first test. It was observed visually that test material was sticking to the stirrer bar. During the second test, the content of test item dissolved in water was 698 g/l. Based on this it was decided to perform a main study at a nominal concentration just above 1000 g/l and to shake the mixtures to prevent the test item from sticking to the stirrer bar.

Main study

The results for the samples taken at 24, 48 and 72 hours are given in the table. After stirring, no undissolved material was observed. The maximum difference (MD) of the concentrations determined in the 24, 48 and 72 hour test samples was ≤ 15%. Based on this, the water solubility of the test item is given as the mean value of the analysed concentrations. In the chromatogram of the pretreated sample from the blank water mixture, a small response was observed. Concentration calculated by extrapolation was 0.0002 g/l which was considered negligible.

Stirring time

[hours]

Analysed

concentration

[g/l]

Mean

[g/l]

MD

[%]

pH

24

1031

1039

8.8

2.2

48

1088

2.1

72

996

2.1

 

The results show that concentration was comparable to the nominal concentration of 1.04 -1.07E+03 g/l. It demonstrated that all test item had dissolved and that water solubility is ≥ 1E+03 g/l.

Conclusion

The flask method was applied for the determination of the water solubility of Ethyl Ascorbic acid.

The water solubility of the test item at 20°C was ≥ 1E+03 g/l.

The pH of the aqueous samples was 2.1 – 2.2.

Applicant's summary and conclusion