2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Dec 2009 - Jan 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Sorafenib tosylate was used as an analogue.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

Principles of method if other than guideline:

not relevant

GLP compliance:

yes

Analytical monitoring:

yes

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Study type:

laboratory study

Substrate type:

artificial soil

Total exposure duration:

14 d

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

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.

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.

Description of key information

A guideline study according to OECD Guideline 207 (Earthworm, Acute Toxicity Test) was performed under GLP to assess the acute toxicity of BAY 54-9085 to earthworm Eisenia fetida. The earthworms were exposed to test concentrations of 0.1, 1.0, 10, 100, and 1000 mg a.i./kg dry soil and a control treatments over 14 days. 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). In order to estimate an LC50 value the mortality was assessed 7 and 14 days after experimental start. On day 14, no mortality was observed, neither in the controls nor at 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. 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.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw