Registration Dossier
Registration Dossier
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EC number: 608-209-4 | CAS number: 284461-73-0
Endpoint summary
Administrative data
Description of key information
Additional information
The test substance BAY 43-9006 (sorafenib) was tested in an acute toxicity test with earthworm Eisenia fetida (OECD Guideline 207), in an reproduction test with Collembola (ISO 11267), in an acute toxicity test with terrestrial plants Hordeum vulgare (barley), Beta vulgaris (sugar beet), and Lactuca sativa (lettuce) (OECD Guideline 208), and in an nitrogen transformation test (OECD Guideline 216) to asses toxicity to soil microorganisms. All 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 mortality was observed within the acute toxicity test with earthworm after a period of 14 days at 1000 mg a.i./kg dry soil treatment.
No influence on the reproduction of collembola was observed within the limit test after a period of 28 days at 1000 mg a.i./kg dry soil.
No effects on plant development were observed during the test with terrestrial plants and also no phytotoxic effects were observed after a period of 21 days at 100 mg a.i./kg dry soil for all species.
No inhibitory effect of the test item on soil microorganisms concerning nitrate production was found after a period of 28 days at 250 mg a.i./kg.
The LD50 is > 1000 mg a.i./kg dry soil (earthworm).
The NOEC for reproduction was determined to be 1000 mg a.i./kg dry soil (collembola).
The NOEC and LOEC for shoot dry weight are 10 and 100 mg a.i./kg dry soil for all species, respectively (plants).
The the NOEC and LOEC for seedling emergence are 100 and >100 mg a.i./kg dry soil for all species, respectively (plants).
The NOEC is 250 mg a.i./kg (soil microorganisms).
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