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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental starting date: 17 July 2017. Experimental completion date: 23 August 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Specific details on test material used for the study:
Identification: Ethylglycol dibenzoate CAS 94-49-5
Description off-white solid flakes
Batch number: 10000005282
Purity 99.4%
Expiry date: 31 December 2021
Storage conditions room temperature, in the dark
Key result
Water solubility:
0.002 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 6.8 - <= 7.1
Details on results:
Preliminary Test
The preliminary estimate of the water solubility at 20.0 ± 0.5 °C was 1.65 x 10-3 g/L. The solution had a pH of 7.2.

Validation
The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 1 to 10 mg/L. The results were satisfactory with a correlation coefficient (r) of 0.9999 being obtained.

Discussion
As the water solubility was determined during the preliminary test to be below 10-2 g/L and the test item was a solid, the column elution method was performed.
The analysis for the 39 and 44 hours samples was run with a 72:28 v/v methanol:water mobile phase in error. The linearity validation was for the intended 65:35 v/v ratio only. It was considered that this difference had negligible effect on the results as the response factor for the standards in both mobile phase ratios was essentially the same.
For both systems, all the sample results were within ± 30 % of the system’s mean result of 1.62 x 10-3 to 3.00 x 10-3 g/L for System A and 1.60 x 10-3 to 2.96 x 10-3 g/L for System B. Therefore, the test fulfilled the requirement of the test guidelines.

The overall results are shown in the following table

System Mean Concentration Standard Deviation
A 2.31 x 10-3 4.06 x 10-2
B 2.28 x 10-3 0.111

Overal result: 2.3 x 10 -3 g/L at 20.0 ± 0.5 °C.

Conclusions:
The water solubility of the test item has been determined to be 2.3 x 10-3 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

Water Solubility. 2.3 x 10-3 g/L of solution at 20.0 ± 0.5 °C, using the column elution method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

Description of key information

The water solubility of the test item has been determined to be 2.3 x 10-3 g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

Water solubility:
2.3 mg/L
at the temperature of:
20 °C

Additional information