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

Toxicity to terrestrial plants

Link to relevant study record(s)

Reference

Endpoint:

toxicity to terrestrial plants: long-term

Type of information:

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

Adequacy of study:

key study

Study period:

Jul - Aug 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 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. QA statement)

Analytical monitoring:

yes

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

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.

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

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%.

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.

Description of key information

A guideline study according to OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test) was performed under GLP to assess the acute toxicity of BAY 54-9085 to terrestrial plants Hordeum vulgare (barley), Beta vulgaris (sugar beet), and Lactuca sativa (lettuce) over 21 days. The test substance was applied at 1.0, 10 and 100 mg a.i./kg dry soil. Additionally, an untreated control was performed. 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%. Any variations in colouring etc were deemed to be within the normal ranges for the plant species tested. 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 mg a.i./kg dry soil for all species, respectively. The the NOEC and LOEC for seedling emergence were 100 and >100 mg a.i./kg dry soil for all species, respectively.

 

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for terrestrial plants:

100 mg/kg soil dw