Registration Dossier

Administrative data

Endpoint:
toxicity to terrestrial plants: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jul - Aug 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
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes (incl. certificate)

Test material

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

Sampling and analysis

Analytical monitoring:
yes

Test organisms

open allclose all
Species:
Lactuca sativa
Plant group:
Monocotyledonae (monocots)
Details on test organisms:
- Common name: lettuce
- Variety: Attraktion
- Source of seed:
Species:
Beta vulgaris
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: sugar beet
- Variety: Evelina
- Source of seed: Landi, Goldach, Switzerland
Species:
Hordeum vulgare
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: barley
- Variety: Eunova
- Source of seed: Landi, Goldach, Switzerland

Study design

Test type:
seedling emergence toxicity test
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
21 d
Remarks:
after 50% control emergence.

Results and discussion

Effect concentrationsopen allclose all
Species:
Hordeum vulgare
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
100 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Hordeum vulgare
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Species:
Beta vulgaris
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
100 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Beta vulgaris
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Species:
Lactuca sativa
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
100 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
seedling emergence
Species:
Lactuca sativa
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth

Any other information on results incl. tables

No effects on plant development were observed during the test. No phytotoxic effects were observed, the mean survival of the emerged plants was more than 90%.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
For all species, effects on the shoot dry weight data were statistically significant at the 100 mg/kg dry soil treatment level. The NOEC and LOEC for shoot dry weight were 10 and 100 mga.i./kg dry soil for all species, respectively. For all species, the NOEC and LOEC values were calculated to be 100 and >100 mg a.i./kg dry soil for percent emergence, respectively.
Executive summary:

The purpose of this study was to estimate the potential effects of BAY 54-9085 on the emergence and seedling growth of three non-target plants species. The methods described in this study plan meet the requirements specified in the OECD Guideline for Testing of Chemicals #208, Terrestrial plant test, Seedling emergence and seedling growth test (OECD, 2006).

Barley ¿ Hordeum vulgare Seedling emergence: Fourteen and twenty-one days after at least 50% of the seedlings emerged, 90.0, 83.3, 91.7 and 87.5% emergence was observed in the control, the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively. This was equivalent to 7.4, -1.9 and 2.8% in the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively, compared to the control. No statistically significant effects compared to the control were observed at any of the treatment levels (Dunn¿s multiple comparison-Kruskal-Wallis, p > 0.05) Survival was 100% in the control and the three test item treatments. Dry weight: Mean dry weight was 127, 127, 131 and 98.1 mg in the control, the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively. This was equivalent to a reduction when compared to the control of 0, -2.99 and 22.9% in the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively. Statistically significant effects compared to the control were observed at 100 mg a.i./kg dry soil (Bonferroni t-test, p <0.05). No effects on plant development (e.g. growth stage) were observed during the test. Any variations in colouring etc were deemed to be within the normal ranges for the plant species tested.

Sugar beet ¿ Beta vulgaris Seedling emergence: Twenty-one days after at least 50% of the seedlings emerged, 87.5, 100, 91.7 and 100% emergence was observed in the control, the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively. This was equivalent to -14.3, -4.8 and -14.3% in the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively, compared to the control.. No statistically significant effects compared to the control were observed at any of the treatment levels (Dunn¿s multiple comparison-Kruskal-Wallis, p > 0.05) Survival was 100% in the control and the three test item treatments Dry weight: Mean dry weight was 73.7, 57.1, 64.2 and 34.6 mg in the control, the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively. This was equivalent to a reduction when compared to the control of 22.5, 12.9 and 53.1% in the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively.

Statistically significant effects compared to the control were observed at 100 mg a.i./kg dry soil (Bonferroni t-test, p < 0.05). No effects on plant development (e.g. growth stage) were observed during the test. Any variations in colouring etc were deemed to be within the normal ranges for the plant species tested.

Lettuce ¿ Lactuca sativa Seedling emergence: Twenty-one days after at least 50% of the seedlings emerged, 60.0, 50.0, 75.0 and 85.0% emergence was observed in the control, the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively. This was equivalent to 16.7, -25.0 and -41.7% in the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively, compared to the control. No statistically significant effects compared to the control were observed at any of the treatment levels (Bonferroni ttest, p > 0.05) Survival was 100% in the control and the three test item treatments. Dry weight: Mean dry weight was 72.4, 63.5, 53.8 and 47.3 mg in the control, the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively. This was equivalent to a reduction when compared to the control of 12.3, 28.6 and 34.7% in the 1.0, 10 and 100 mg a.i./kg dry soil treatments respectively.

Statistically significant effects compared to the control were observed at 100 mg a.i./kg dry soil (Bonferroni t-test, p < 0.05). No effects on plant development (e.g. growth stage) were observed during the test. Any variations in colouring etc were deemed to be within the normal ranges for the plant species tested.