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EC number: 253-462-2
CAS number: 37321-62-3
Preliminary test results
Test item quantity
Volume of water added
Time of shake (h)
Presence of an oil
Conclusion of the preliminary test: Due to the presence of lots of
suspended particles at the tested solubility 1 g/L, the solubility was
estimated to be < 10 mg/L.
The behaviour of the test item like an oil permitted to anticipate
that the loading of the column was a critical phase. Therefore, an
amendment was signed to realise a slow-stirring method.
An adaptation of the shake flask method was also realised
(non-GLP) to observe the consequence of vigorous agitation on the
kinetic of the solubility.
Adapted flask method results
Only one phase was observed so the flasks were centrifuged at 20
°C and 4500 rpm during 2h
The centrifugation did not permit to separate the phases. Only one
white phase was observed. So the sampling could not be realised.
The solubility could not be measured because only one white phase
Slow-stirring method results
* LOQ = Limit of quantification (available in the last row of the
Water solubility calculation
Using results of the certificate of analysis provided by the
sponsor, equivalent to each substance quantified was calculated:
Peak of Monoester 1
Peak of Diester 1
Area Sum %of the test tiem
Equivalent concentration in test item [mg/L]
The solubility at 20 °C of the test item was measured with the
slow-stirring method after 10 days at 1.28 mg/L with the monoester
quantification and < 0.24 mg/L with the diester quantification.
The sampling difference ((S2-S1/S1) of the at least two last
sampling would not differ by more than the analytical method MBA (30 %).
This criterion was verifed for all flasks.
Equivalent concentration in testitem [mg/L]
Sampling difference [%]
** N/A: Not Applicable calculation because the quantification was
The relative standard deviation (RSD) between the sampling will
not be upper than the analytical method MBA (30%). This criterion was
RSD Validity Criteria
< 30 %
* N/A: Not Applicable calculation because the quantification was <
Using the flask method, the solubility at 20 °C of the test item
could not be measured because only one phase was observed after
centrifugation (4500 rpm ; 2 h ; 20 °C).
By applying the slow-stirring method, the solubility at 20 °C of
the test item was measured after 10 days between < 0.24 mg/L to 1.28
mg/L in function of the ester measured.
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