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EC number: 213-561-3
CAS number: 980-26-7
The intended hydrolysis determination of the test item at different pH
values was based an the OECD Guideline No. 111, "Hydrolysis as a
Function of pH"; adopted May 12, 1981 and an the EEC Directive 92/69,
Section C.7, "Abiotic Degradation: Hydrolysis as a Function of pH", L383
A, December 1992.
The solubility of the test item in the buffer solutions pH 4.0, pH 7.0
and pH 9.0 was very low. lt was not possible to increase the solubility
of the test item with the use of different solubilizers (Acetonitrile,
dimethyl formamide, methanol and tetrahydrofurane). Peaks obtained, if
any, were too small to allow quantification or even to follow a
According to the EEC Directive 92/69, Section C.7, the method is
applicable only to water soluble substances. The test item shows no
significant solubility in the different solvent systems. Therefore, no
further testing could be performed with the test item at pH 4.0, pH 7.0
and pH 9.0.
The abiotic degradation of the substance cannot be determined, because there are no functional groups present in the molecule which could undergo hydrolytic cleavage in aqueous media (e.g. ester, ether or amide functions). Therefore, the study is scientifically not necessary.
In addition, the pigment is practically not soluble in water (water solubility: 5.6 µg/L)
Nevertheless, for the test item, the potential for hydrolytic degradation had been tested according to OECD-guideline for testing of chemicals no. 111 and E.U-method C.7 according to GLP (reliability category 1).
The test could not proceed further as to the first recovery-experiments after preparation of the buffered solutions of the test substance. In spite of trying 4 different co-solvents to increase dissolution of the test item in the buffer solutions all the resulting solutions were too dilute to be detectable by analytics based on HPLC/UV-Vis-spectroscopy after chemical derivatization (LOQ about 0.007 µg/mL).
Therefore, solubility of the test item in buffered solutions is far too low to allow for testing of the potential for hydroyltic degradation.
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