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EC number: 700-957-0
CAS number: 1141852-17-6
In the study C76471, Harlan Laboratories was supposed to develop a
method to analyze the test item Y-15866 in test water. To conduct the
analytical part of an ecotox study, a sensitive and accurate method is
needed. The test item Y-15866 is highly unstable in water (see Harlan
study C76302, Y-15866: Determination of the Water Solubility)
(Weissenfeld, 2010). This makes it very difficult to develop an
analytical method to analyze Y-15866 in water samples. According to the
sponsor’s information, most of the Y-15866’s degradation products (i.e.
the silanols) are unstable in water, too. They are polymerizing forward
and the resulting polymers seem to precipitate. The exception is the
degradation product 2-methyl-1,3-propanediol (MPD). This could be
analyzed by the sponsor’s gas chromatography method for the neat
substance. However, due to the presence of MPD in the test item it would
not be possible to distinguish between intrinsic MPD and produced MPD,
since the content of MPD in Y-15866 is unknown. The Water Accommodated
Fraction (WAF) samples from pre-experiments using an LC-MS/MS method
were analysed. However, neither traces of the cyclic monomer (m/z=233)
nor of the bridged dimer (m/z= 375) could be detected above LOQ of 0.1 μg/mL.
Thus, for quantification of the test item in the ecotox tests the
sensitivity of this method was not sufficient. Thus, no appropriate
substance specific analytical method could be set up for Y-15866. For
the non-specific determination of the Y-15866, measurement of silicon
(Si) by atomic absorption spectroscopy or total organic carbon content
analysis (TOC-measurements) were discussed. Due to the ubiquitous
presence of Silicon, it was decided in accordance with the sponsor to
analyze the TOC in the test water samples.
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