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BAY 43-9006 (sorafenib) was tested in an acute immobilization and chronic reproduction test in Daphnia magna, in the green algae groth inhibition test with Desmodesmus subspicatus, in the acute fish test in the zebrafish, in the ELS test in the fish fathead minnow, and in the actvated sludge respiration inhibition test. All tests except the acute Daphnia and fish tests were performed with the tosylate salt. Since the methylbenzenesulfonate (tosylate) part of the molecule is not assumed to influence the toxicity of sorafenib, the results from these studies can be used to determine the aquatic toxicity of BAY 43 -9006.

No immobilization was observed in the acute immobilization test with D.magna after a test period of 48h at a measured concentration of <0.031 mg/L.No influence on reproduction as observed up to the saturation limit og 0.00086 mg/L in the chronic Daphnia test.

No growth inhibition was observed in the algal growth inhibition test after a test period of 72 h.

No effect in fish was observed in the acute toxicity test with the zebrafish Danio rerio over a test period of 96h. The test concentration (limit test) was a saturated solution of BAY 43 -9006. Therefore, ist was established that BAY 43 -9006 is not acutely toxic to fish up to the solubility limit. The results of the chronic fish study showed that sorafenibtosylate has effects on growth and survival of fish (fathead minnow) at concentrations from 0.0001 mg/L onwards. Thus, the overall no observed effect concentration (NOEC) was <0.0001 mg/L, the lowest observable effect concentration (LOEC) was 0.0001 mg/L. The EC10 was 0.00017 mg/L (survival). Activated sludge was not inhibited by a saturated solution of the tosylate of BAY 43-9006.

Since there were no acute effects of BAY 43 -9006, it has to belabeled accordingly. However, the studies with the tosyltae of BAY 43 -9006 showed a chronic toxicity in fish. Due to the lack of ready biodegradability and a log Pow >3, the compound should be labeled for its chronic aquatic toxicity.