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Environmental fate & pathways

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A guideline study on the test substance according to 92/69/EEC Method C.4-D was conducted under GLP conditions to assess the biodegradation of BAY 43-9006 in water over 28 days. During this study on ready biodegradability a degradation rate of 2% after 28 days was determined at nominal test concentration of 100 mg/L. In a further study according to the OECD 301F, sorafenib tosylate was used as an analogue of the test substance. Sorafenib tosylate was degraded to 0 % after 28 days (at a concentration of 200 mg ThOD) and it was not toxic to the microbes of activated sludge. Therefore, the test substance has to be classified as "Not Readily Biodegradable". A guideline study according to OECD 308 was conducted to assess the biodegradation of [14C]-sorafenib tosylate (as an analogue of the test substance) in an aerobic water/sediment system over 100 days. Test vessels were exposed to a start concentration of 0.22 mg/L in water phase (nominal concentration). [14C]-sorafenib tosylate was removed rapidly from the water fraction and bound to the sediment in both sediment-systems (DT50 for water was <1 d at 22°C corresponding to <2.5 d at 12°C). Ultimate biodegradation was low and accounted for 0.7 and 1.1 % of the radioactivity in sediment 1 and 2, respectively. Because of the lack of relevant biodegradation, the test substance is assumed to accumulate in the sediment. A guideline study according to OECD 307 under GLP was conducted to assess the biodegradation of [14C]BAY 54-9085 (also named sorafenib tosylate which is an analogue of the test substance) in soil. The soil was exposed to a nominal test concentration of 1000 µg/kg soil (dw). No major metabolites were detected and only minor mineralization to CO2 was observed throughout the study. The degradation of the sorafenib tosylate is accompanied by increasing levels of non-extractable residues in soil. The DT50 of the test substance in aerobic sandy loam soil Sevelen were calculated to be 187d at 20°C (corresponding to 397d at 12°C). Therefore, the test substance is only slowly degraded in soil under aerobic conditions. Overall, under aerobic conditions the test substance is not readily biodegradable, get rapidly removed from water and accumulate in the sediment and soil compartment.