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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

BAY 43-9006 (sorafenib) was tested in an acute immobilization and chronic reproduction test with Daphnia magna, in the green algae groth inhibition test with Desmodesmus subspicatus, in the acute fish test with 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 Daphnia magna after a test period of 48h at a measured concentration of <0.031 mg/L.

No influence on reproduction was observed up to the saturation limit of 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, it 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 sorafenib tosylate 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.