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

Toxicity to terrestrial arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to terrestrial arthropods: short-term

Type of information:

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

Adequacy of study:

key study

Study period:

Feb - Mar 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:

ISO 11267 (Inhibition of Reproduction of Collembola by Soil Pollutants)

Deviations:

no

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes (incl. QA statement)

Application method:

soil

Test organisms (species):

Folsomia candida

Animal group:

Collembola (soil-dwelling springtail)

Study type:

laboratory study

Limit test:

yes

Total exposure duration:

28 d

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

After 28 days of exposure, a mortality of 15 and 18% was observed in the control and solvent control, respectively, which met the validity criterion stated in the study plan (i.e., 20% mortality in the control(s)). In the 1000 mg a.i./kg dry soil treatment and the toxic standard a mortality of 4 and 22% was found, respectively.

Validity criteria fulfilled:

yes

Conclusions:

The NOEC for reproduction was determined to be 1000 mg a.i./kg dry soil.

Executive summary:

The objective of this study was to determine the potential effects of BAY 54-9085 on the reproduction of the springtail Folsomia candida (Collembola). The springtails were exposed to a concentration of 1000 g a.i./kg (limit test) in an artificial soil medium for a period of 28 days. After this period, the number of offspring was determined.

The mean numbers of juveniles per vessel in the control and the solvent control were 507 and 392, with a coefficient of variation of 29.6 and 21.9%, respectively, which met the performance criteria stated in the study plan (i.e., 100 juveniles in the control(s) and a coefficient of variation <30). In the 1000 mg a.i./kg dry soil treatment and the toxic standard, the mean numbers of juveniles per vessel were 395 and 42.0, respectively. Statistical analysis demonstrated a significant difference in reproduction among springtails exposed to the toxic standard when compared to the pooled controls (Mann- Whitney Test: p < 0.05). The NOEC for reproduction was determined to be 1000 mg a.i./kg dry soil.

Description of key information

A guideline study according to ISO 11267 (Inhibition of Reproduction of Collembola by Soil Pollutants) was performed under GLP to assess the acute toxicity of BAY 54-9085 to soil terrestrial arthropods Folsomia candida. The springtails Folsomia candida were exposed to a concentration of 1000 g a.i./kg (limit test) and control treatments in an artificial soil medium for a period of 28 days. After this period, the number of offspring was determined. After 28 days of exposure, a mortality of 15 and 18% was observed in the control and solvent control, respectively. In the 1000 mg a.i./kg dry soil treatment and the toxic standard a mortality of 4 and 22% was found, respectively. Statistical analysis demonstrated a significant difference in reproduction among springtails exposed to the toxic standard when compared to the pooled controls (Mann- Whitney Test: p < 0.05). The NOEC for reproduction was determined to be 1000 mg a.i./kg dry soil.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil dwelling arthropods:

1 000 mg/kg soil dw