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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Dec 2009 - Jan 2010
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted with sorafenib-tosylate according to OECD guideline under GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Principles of method if other than guideline:
not relevant
GLP compliance:

Test material

Constituent 1
Reference substance name:
Cas Number:
Details on test material:
- Name of test material (as cited in study report): Sorafenib tosylate
- Analytical purity: BXA4DZ4
- Lot/batch No.: 99.5%

Sampling and analysis

Analytical monitoring:

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:

Study design

Study type:
laboratory study
Substrate type:
artificial soil
Total exposure duration:
14 d

Results and discussion

Effect concentrations
14 d
Dose descriptor:
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:

Any other information on results incl. tables

On day 14, no mortality was observed in either the controls or the 0.1, 1.0, 10 and 100 mg a.i./kg dry soil treatment levels. The 1000 mg a.i./kg dry soil treatment level showed 10% mortality due to a missing worm. Since missing earthworms, even crawling out of test vessel, were presumed as dead, this mortality was not considered to be test item related.

Applicant's summary and conclusion

No mortality was observed in the controls and the 1000 mg a.i./kg dry soil treatment. Therefore, the 14 day LD50 were empirically estimated to be
> 1000 mg a.i./kg dry soil.
Executive summary:

The objective of this study was to determine the acute toxicity of BAY 54-9085 to the earthworm Eisenia fetida (Oligochaeta: Lumbricidae). In order to estimate an LC50 value the mortality was assessed 7 and 14 days after experimental start.

The test was conducted in a temperature-controlled environmental chamber to maintain the test conditions specified in the study plan: a temperature of 20 ± 2ºC and continuous light intensity of approximately 400 to 800 lux. The concentration tested and the corresponding mortality data derived from the definitive toxicity test were used to estimate the 7- and 14-day median lethal concentrations (LC50) and the No-Observed Effect Concentration (NOEC). The LC50 value is defined as the concentration of test item which caused a 50% reduction in survival. The NOEC is defined as the highest concentration which demonstrated no statistically-significant adverse effect (p ¿ 0.05) when compared to the pooled control data. Since no mortality was observed in the 1000 mg a.i./kg dry soil treatment, the control and the solvent control, no statistical analyses were performed.

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