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Endpoint:
hydrolysis
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

In accordance with column 2 of REACH Annex VIII, hydrolysis as a function of pH study (required in section 9.2.2.1) does not need to be conducted if the substance is highly insoluble in water. The substance's water solubility is <0.51 µg/L at 20 °C as determined in the Water Solubility test for the sodium form. Similarly, the water solubility of the sodium/hydrogen form is determined to be less than or equal to 7.43 µg/L at 20 °C. The substance is therefore highly insoluble in water.
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Flask method: water solubility <0.51 µg/L at 20 °C (EU Method A6 and OECD 105 with slight deviations, GLP) 
Water solubility:
0.51 µg/L
at the temperature of:
20 °C

During the preliminary study the water solubility of the sodium form test item was estimated to be < 0.005 mg/L. Method A6 Water solubility (440/2008/EC) recommends that the column elution method should be used if the water solubility is < 1x10^-2 g/L. However, since the substance is insoluble in organic solvents, the column elution method could not be applied.

 

Using the flask method, the sample solution signals in the main test with the sodium form were below the limit of detection (LOD = 5.10 x 10^-7 g/L). Similarly, the water solubility of the sodium/hydrogen form was determined to be less than or equal to 7.43 x 10^-6 g/L. The substance is therefore very poorly soluble in water.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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