Attachment 10



# TF~T Di A7O -ipany Sanititid



# p_ oy- 366 f_~ ~.p. 2 Attachment 10

While small concentrations of test itemare not completely soluble in water (e.g. 16.6 mg/I), the test itemis, on the other hand, able to form homogeneous mixtures at high concentrations. Due to this behavior, it is not possible to determine a defined water solubility of the test item . 1 Water Solubility Summary The test itemis partly miscible with/soluble in water, depending on the ratios of test itemto water applied. While small concentrations of test itemare not completely soluble in water (e.g. 16.6 mg/I), the test itemis, on the other hand, able to formhomogeneous mixtures at high concentrations. Due to this behavior, it is not possible to determine a defined water solubility of the test item . Physical State At roomtemperature the test itemis a clear viscous darkyellowcolored liquid. General Remark The test itemconsists of a mixture of homologues with different molecular weights and, in addition to this, probably of different secondary components. Every constituent of this mixture contributes to a different degree to overall solubility, depending on its own individual solubility and its mass fraction in the test item . For determination of the water solubility, the preparation of saturated solutions of the test item in water is required. Since this is not possible for this test item, the solubility in water can only be investigated by a visual method using different proportions of test itemand water . Pre-testing 16.9 mg of the test itemwere mixed with 10 ml, 13.6 mg of the test itemwere mixed with 100 ml and 16.6 mg of the test item were mixed with 1000 ml of water at 23°C . After the addition of water, the test itemwas floating on the surface of the water and after stirring overnight at 23°C, the test itemwas finely dispersed in the water phases, resulting in turbid solutions. Thus, the water solubility of the test itemwas estimated to be < 16.6 mg/I . Remark: This pre-testing merely shows that 16.6 mg of the test itemare not completely soluble in one liter of water. As the test itemis not a pure compound but a mixture of compounds with possibly different properties, it may be that the water solubility of fractions of the test itemis higher than 16.6 mg/I . Method The determinations were done according to OECDGuideline for the Testing of Chemicals, 105, flask method .p. 3 Attachment 10

Although the water solubility was estimated to be < 16.6 mg/l, the flask method was carried out instead of the column elution method, because the test itemis not a defined single compound. As it was not possible to produce saturated solutions without undissolved amounts of test itemaccording to the flask method, additional preparations of the test itemwith different amounts of water were carried out to investigate the miscibility and the solubility behavior of the test item . Reagent Deminerafized water (Milli-Q System) Analytical Method Preparations according to the flask method (OECD 105) : About 100 mg and about 1000 mg of the test itemwere each mixed with 100 ml of water and then stirred at roomtemperature (23°C) for 24h . Other preparations with the same concentrations were stirred for 48 h and for 72 h . Afterwards the mixtures were conditioned at 20.0°C ± 0.5 °C for 24 h. After that, the mixtures were strongly turbid. The undissolved amounts of the test itemcould not be removed, neither by filtration nor by centrifugation. Thus, it was not possible to achieve defined saturated solutions of test item in water . Preparations for visual investigation: The test itemand water were mixed in different ratios and agitated on a roller mixer at roomtemperature (T = 23°C) to investigate the solubility / miscibility behaviour of the test item . The following mixtures were prepared : 

### ratio m

test item m

water I m

ti / m mixture ~ Observations 191 f9] i [9 / 100 g] i 1 :9 1 .01 ~ 9 .02 ' 10.1 i After agitating overnight, the homogeneous yellowish and jelly-like mixture was turbid with inclusions of air . 1 :1 2.07 ~ 2.17 I 48.8 After agitating overnight, the homogeneous yellow ~ andjelly-like mixture was turbid with inclusions of air. 9:1 j 4.51 , 0.54 89.3 After agitating overnight, the homogeneous yellowbrown and jelly-like mixture was slightly turbid with inclusions of air . Result The test item is partly miscible with/soluble in water, depending on the ratios of test itemto water applied. While small concentrations of the test itemare not completely soluble in water (e.g . 16.6 mg/I, see pre-testing), the test item is, on the other hand, able to form homogeneous mixtures atp. 4 Attachment 10

high concentrations . Due to this behavior, it is not possible to determine a defined water solubility of the test item . 

### Date of testp. 5 Attachment 10p. 6 Attachment 10

GLP Comnliance Statementp. 7 Attachment 10



# I