Registration Dossier

Administrative data

Endpoint:
toxicity to terrestrial arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb - Mar 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted with sorafenib tosylate according to ISO 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
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
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. certificate)
Application method:
soil

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sorafenib tosylate BAY 54-9085
- Analytical purity: 99.5%
- Lot/batch No.: BXA4DZ4

Test organisms

Test organisms (species):
Folsomia candida
Animal group:
Collembola (soil-dwelling springtail)

Study design

Study type:
laboratory study
Limit test:
yes
Total exposure duration:
28 d

Results and discussion

Effect concentrations
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.