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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Dec 2009 - Jan 2010
Reliability:
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:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Deviations:
no
Principles of method if other than guideline:
not relevant
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
yes

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:
annelids

Study design

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

Results and discussion

Effect concentrations
Duration:
14 d
Dose descriptor:
LD50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

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

Conclusions:
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.