1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide

Toxicity to terrestrial plants

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to terrestrial plants: long-term

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

24 Sep - 22 Oct 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.4150 (Terrestrial Plant Toxicity Tier I (vegetative vigor))

Version / remarks:

2012

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 227 (Terrestrial Plant Test: Vegetative Vigour Test)

Version / remarks:

2006

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Analytical monitoring:

no

Remarks:

Test item stock solution of 300 g a.s./ha and of deionised water were analyzed via HPLC-UV

Vehicle:

no

Details on preparation and application of test substrate:

- Preparation of test solution: stock solution, with an equivalent rate of 300 g a.s./ha, was prepared by dissolving the test item in deionised water. The stock solution itself was not applied but needed for analytical purposes. The test item rate was prepared by dilution of the test item stock solution with deionised water. The amount of deionised water needed to prepare each test item rate was determined gravimetrically.
- Method of application to soil surface: control solution followed by the test item application rate of the test item, were applied once onto the leaves and above-ground portions of the plants, using a linearcabinet track sprayer (SprayLab SLGH 2500).
- Type of nozzles: Teejet 8001 EVS (one nozzle was used)
- Spray pressure: 3.55 bar
- Application speed: 2 km/h
- Distance (nozzle – target area): 30 cm
- Application rate: 200 L/ha ±10%
- Controls: deionised water only

Species:

Beta vulgaris

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Sugar beet
- Plant family: Chenopodiaceae
- EPPO code: BEAVA
- Variety: 2VK1433
- Source of seed: KWS Saat AG
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 95%

Species:

Brassica napus

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Oilseed rape
- Plant family: Brassicaceae
- EPPO code: BRSNW
- Variety: Fontan
- Source of seed: Schlereth
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 100%

Species:

Cucumis sativus

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Cucumber
- Plant family: Cucurbitatceae
- EPPO code: CUMSA
- Variety: Delikatess
- Source of seed: Enza Zaden
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 100%

Species:

Glycine max (G. soja)

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Soybean
- Plant family: Fabaceae
- EPPO code: GLXMA
- Variety: Sultana
- Source of seed: Schlereth
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 100%

Species:

Helianthus annuus

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Sunflower
- Plant family: Asteraceae
- EPPO code: HELAN
- Variety: Pacino Cola
- Source of seed: Schlereth
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 95%

Species:

Lycopersicon esculentum

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Tomato
- Plant family: Solanacae
- EPPO code: LYPES
- Variety: Balkonstar
- Source of seed: Enza Zaden
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 90%

Species:

Allium cepa

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Onion
- Plant family: Liliacae
- EPPO code: ALLCE
- Variety: Braunschweiger Blutrot
- Source of seed: Enza Zaden
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 90%

Species:

Avena sativa

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Oat
- Plant family: Poacae
- EPPO code: AVESA
- Variety: Flämmingsstern
- Source of seed: Schlereth
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 100%

Species:

Triticum aestivum

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Wheat
- Plant family: Poacae
- EPPO code: TRZAW
- Variety: Flämmingsstern
- Source of seed: Samen Schmitt
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 95%

Species:

Zea mays

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Corn
- Plant family: Poacae
- EPPO code: ZEAMA
- Variety: Aventura
- Source of seed: Schlereth
- Prior seed treatment: The seeds had no chemical treatments or pesticide coatings.
- Historical germination of seed: 100%

Test type:

vegetative vigour test

Study type:

laboratory study

Substrate type:

natural soil

Limit test:

yes

Total exposure duration:

21 d

Test temperature:

19.88°C - 24.85°C

Details on test conditions:

TEST SYSTEM
- Testing facility: Greenhouses from Bayer CropScience AG
- Test container: plastic flower pots (15 cm diameter)
- Method of seeding: manual introduction to soil, pressing of seeds into surface soil to complete coverage of layer soil (prior to testing)
- Life stage of plants: 2 - 4 leaf stage
- No. of seeds/plants per container: ALLCE, AVESA and TRZAW: 4, BEAVA, BRSNW, CUMSA, GLXMA, HELAN, LYPES and ZEAMA: 2
- No. of replicates per treatment group: ALLCE, AVESA and TRZAW: 8, BEAVA, BRSNW, CUMSA, GLXMA, HELAN, LYPES and ZEAMA: 16
- No. of replicates per control: ALLCE, AVESA and TRZAW: 8, BEAVA, BRSNW, CUMSA, GLXMA, HELAN, LYPES and ZEAMA: 16

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: Riedberg, Frankfurt am Main, Germany
- Composition: “Riedberg” soil, washed sand (ratio 9/1) from Bayer AG, Horticulture und Services, Frankfurt, Germany, sieved to 2 mm
- sand: fine sand: 4.9%, middle sand: 20.3%, coarse sand
- silt: fine silt: 4.9%, middle silt: 17.8%, coarse silt: 28.9%
- clay: 17.1%
- Organic carbon: 0.72%
- pH value: 6.92 (CaCO3)
- Pretreatment of soil: Sterilisation by vapour pressure at 120°C for approximately 30 minutes.

GROWTH CONDITIONS
- Photoperiod: 16 h light and 8 h dark
- Light source: artificial lighting
- Light intensity and quality: Natural daylight, 926.32 - 9613.63 lux
- Day/night temperatures: 19.88°C - 24.85°C
- Relative humidity: 67.25% - 85.12%
- Watering regime and schedules: Bottom watering was performed with saucers standing below each pot throughout the study. Water was given and retained within the saucer according to the need of the plants to maintain an optimal water supply for plant growth.
- Any pest control fertilization: liquid fertilizer (Wuxal Top N)

EFFECT PARAMETERS MEASURED:
- Survival (7, 14 and 21 days after application)
- Phytotoxicity (assessed according to EPPO Standard 135)
- Description of symptoms assessed
- Growth stages (according to BBCH Monograph - Growth stages)
- Shoot length
- Shoot dry weight (Plants were cut directly at the soil surface and put in pre-weighed bags and dried at 60°C and reweighed – considering tare weight – to obtain the shoot dry weight of each replicate.)

- Phytotoxicity rating system: Phytotoxicity was recorded from the living plants at each assessment date following a 0-90% rating system in 10% steps. 0%: no injury or effect, 10, 20%: slight symptom, 30, 40%; moderate symptom, 50, 60%: severe symptom, 70, 80%: total plant symptom, 90%: moribund

Nominal and measured concentrations:

0, 200 g a.s./ha (nominal)
0, 0.2667 g a.s./kg dw (calculated)

Reference substance (positive control):

no

Species:

Lycopersicon esculentum

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

< 200 g/ha

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: shoot dry weight and shoot length

Remarks on result:

other: Statistically significant reduction of 9.8% and 4.7%. However, no adverse effects on survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight above the 25% effect level were observed

Species:

Lycopersicon esculentum

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

< 0.267 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: shoot dry weight and shoot length

Remarks on result:

other: Statistically significant reduction of 9.8% and 4.7%. However, no adverse effects on survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight above the 25% effect level were observed

Species:

other: Beta vulgaris, Brassica napus, Cucumis sativus, Glycine max, Helianthus annus, Allium cepa, Avena sativa, Triticum aestivum, Zea mays

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 200 g/ha

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight

Species:

other: Beta vulgaris, Brassica napus, Cucumis sativus, Glycine max, Helianthus annus, Allium cepa, Avena sativa, Triticum aestivum, Zea mays

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.267 µg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight

Details on results:

No adverse effects on survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight above the 25% effect level. Both the shoot dry weight reduction and the shoot length reduction of Lycopersicon esculentum of 9.8% and 4.7%, respectively, was found to be statistically significant at the tested rate.

Table 1: Effect of test item on survival

Plant species	Control		Test item 200 ga.s./ha)
	Number of survived plants	% survival	Number of survived plants	% survival	% inhibition
Beta vulgaris	32	100	32	100	0
Brassica napus	32	100	32	100	0
Cucumis sativus	32	100	32	100	0
Glycine max	32	100	32	100	0
Helianthus annuus	32	100	32	100	0
Lycopersicon esculentum	32	100	32	100	0
Allium cepa	32	100	32	100	0
Avena sativa	28	100	24	100	0
Triticum aestivum	32	100	32	100	0
Zea mays	32	100	32	100	0

 For Avena sativa, due to an irrigation mistake one control pot and two pots out of the test item group were taken out of the assessment and were not included in the calculation.

Table 2: Effect of test item on shoot length

Shoot Length
Plant Species	Mean control (cm)	Mean test item at 200 g a.s./ha(cm)	% inhibition*	Statistical significance
Beta vulgaris	33.3	33.3	-0.2	-
Brassica napus	43.8	42.8	2.1	-
Cucumis sativus	176.0	181.6	-3.2	-
Glycine max	128.9	130.2	-1.0	-
Helianthus annuus	33.7	33.8	-0.4	-
Lycopersicon esculentum	49.4	47.1	4.7	+
Allium cepa	45.3	45.3	0.0	-
Avena sativa	88.5	92.4	-4.4	-
Triticum aestivum	50.5	49.8	1.4	-
Zea mays	149.9	149.0	0.6	-

*:         Negative values indicate that there was an increase compared to the control

Statistical significance -:Inhibition is statistically not significant (Pairwise Mann-Whitney-U-test, one sided

smaller; p ≤ 0.05).

Statistical significance +:Inhibition is statistically significant (Pairwise Mann-Whitney-U-test, one sided smaller;

p ≤ 0.05).

Table 3: Effect of test item on shoot dry weight

Shoot Dry Weight
Plant Species	Mean control (g)	Mean test item at 200 g a.s./ha(g)	% inhibition*	Statistical significance
Beta vulgaris	4.798	4.887	-1.8	-
Brassica napus	8.797	8.553	2.8	-
Cucumis sativus	15.136	15.201	-0.4	-
Glycine max	7.210	6.971	3.3	-
Helianthus annuus	3.748	3.658	2.4	-
Lycopersicon esculentum	5.107	4.608	9.8	+
Allium cepa	0.405	0.406	-0.2	-
Avena sativa	1.704	1.897	-11.3	-
Triticum aestivum	1.486	1.396	6.1	-
Zea mays	9.484	9.508	-0.3	-

*:         Negative values indicate that there was an increase compared to the control

Statistical significance -:Inhibition is statistically not significant (Pairwise Mann-Whitney-U-test, one sided

smaller; p ≤ 0.05).

Statistical significance +:Inhibition is statistically significant (Pairwise Mann-Whitney-U-test, one sided smaller;

p ≤ 0.05).

Table 4: Growth stage (summary at the final assessment)

BBCH Min-Max at the application rate (200 g a.s./ha) at the final assessment
Species	Control	Test item
Beta vulgaris	18-19	19
Brassica napus	17-19	17-19
Cucumis sativus	67-69	67-69
Glycine max	63	63
Helianthus annuus	51	51
Lycopersicon esculentum	52-62	52-61
Allium cepa	41	41
Avena sativa	32-33	32-33
Triticum aestivum	27-29	27-29
Zea mays	31-32	31-32

Table 5: Phytotoxicity of the test item (summary at final assessment)

Phytotoxicity summary (mean damage in %) at the application rate (200 g a.s./ha) at the final assessment
Species	Control	Test item
Beta vulgaris	0	0
Brassica napus	0	1.9 de
Cucumis sativus	0	0
Glycine max	0	0
Helianthus annuus	0	1.3 b
Lycopersicon esculentum	0	0.6 a
Allium cepa	0	0
Avena sativa	0	0
Triticum aestivum	0	3.8 b
Zea mays	0	6.3 e

  Codes for phytotoxic symptoms:

a:        chlorosis (yellowing of greenshoottissue)

b:        necrosis (brown shoottissue)

c:        bleaching (shoot tissue withoutpigmentation)

d:        deformation (e.g. leaf curl, abnormal leaf shape, abnormalplanthabitus)

e:        stunting (plant height reduced with shorter internodelength)

f:         reddening of green shoottissue

 Any plant considered as being dead was not rated for phytotoxicity

Table 6. Validity criteria defined by OECD guideline 227 and study performance.

Performance criteria	Outcome	Criterion fulfilled
Seedling emergence is ≥ 70%.	The germination rate of the seeds used in this study was ≥ 70%.	Yes
In the controls, the plants do not exhibit phytotoxic effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and only normal variation in growth and morphology for that particular species.	The control plants of each species showed normal variation in growth, plant development and morphology.	Yes
In the controls, the mean plant survival is ≥ 90% for the duration of the study.	All plant species showed a survival of ≥ 90% in the control.	Yes
The environmental conditions for a particular species are identical and growing media contain the same amount of soil matrix, support media, or substrate from the same source.	The environmental conditions during the test were identical within each species. The pots used for all species were filled in equal manner with the same soil.	Yes

Analytical results: The analysis of tetraniliprole content in the test item stock solution revealed measured concentrations of 100.5% of nominal.

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.

Reference 2

Endpoint:

toxicity to terrestrial plants: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Sep - 21 Dec 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.4100 (Terrestrial Plant Toxicity Tier I (seedling emergence))

Version / remarks:

2012

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)

Version / remarks:

2006

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Analytical monitoring:

no

Remarks:

Samples of the test item stock solution (300 g a.s./ha) and of deionised water were analyzed

Vehicle:

no

Details on preparation and application of test substrate:

- Preparation of the test substrate: A stock solution, with an equivalent rate of 300 g a.s./ha, was prepared by dissolving the test item in deionised water. The test item rate was prepared by dilution of the test item stock solution with deionised water. The amount of deionised water needed to prepare each test item rate was determined gravimetrically.
- Method of application to soil surface: control solution application rate followed by the test item application rate of the test item. Solutions were applied once onto the soil surface, using a linear cabinet track sprayer (SprayLab SLGH 2500, Schachtner, Ludwigsburg, Germany).
- Type of nozzles: Teejet 8001 EVS (one nozzle was used)
- Spray pressure: 3 bar
- Application speed: 2 km/h
- Distance (nozzle – target area): 30 cm
- Application rate: 200 L/ha ±10%
- Controls: deionised water only

Species:

Beta vulgaris

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Sugar beet
- Plant family: Chenopodiaceae
- EPPO code: BEAVA
- Variety: 2VK 1433
- Source of seed: KWS Saat AG (24 Jun 2014)
- Prior seed treatment: no
- Historical germination of seed: 95%

Species:

Brassica napus

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Oilseed rape
- Plant family: Brassicaceae
- EPPO code:BRSNW
- Variety: Fontan
- Source of seed: Schlereth (10 Oct 2014)
- Prior seed treatment: no
- Historical germination of seed: 100%

Species:

Cucumis sativus

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Cucumber
- Plant family: Cucurbitatceae
- EPPO code: CUMSA
- Variety: Delikatess
- Source of seed: Schlereth (06 Sep 2013)
- Prior seed treatment: no
- Historical germination of seed: 100%

Species:

Glycine max (G. soja)

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Soybean
- Plant family: Fabaceae
- EPPO code: GLXMA
- Variety: Sultana
- Source of seed: Schlereth (27 Jan 2015)
- Prior seed treatment: no
- Historical germination of seed: 100%

Species:

Helianthus annuus

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Sunflower
- Plant family: Asteraceae
- EPPO code: HELAN
- Variety: Pacino Cola
- Source of seed: Schlereth (25 Nov 2013)
- Prior seed treatment: no
- Historical germination of seed: 95%

Species:

other: Solanum lycopersicum

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Tomato
- Plant family: Solanacae
- EPPO code: LYPES
- Variety: Balkonstar
- Source of seed: Schlereth (24 Jul 2015)
- Prior seed treatment: no
- Historical germination of seed: 90%

Species:

Allium cepa

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Onion
- Plant family: Amaryllidaceae
- EPPO code: ALLCE
- Variety: Braunschweiger Blutrot
- Source of seed: Enza Zaden (06 Aug 2015)
- Prior seed treatment: no
- Historical germination of seed: 90%

Species:

Avena sativa

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Oat
- Plant family: Poacae
- EPPO code: AVESA
- Variety: Flämingsstern
- Source of seed: Schlereth (14 Mar 2011)
- Prior seed treatment: no
- Historical germination of seed: 100%

Species:

other: Triticum aestivum

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Wheat
- Plant family: Poacae
- EPPO code: TRZAW
- Variety: Dekan
- Source of seed: Schlereth (04 May 2012)
- Prior seed treatment: no
- Historical germination of seed: 95%

Species:

Zea mays

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Corn
- Plant family: Poacae
- EPPO code: ZEAMA
- Variety: Aventura
- Source of seed: Schlereth (13 Nov 2014)
- Prior seed treatment: no
- Historical germination of seed: 95%

Test type:

seedling emergence and seedling growth test

Study type:

laboratory study

Substrate type:

natural soil

Limit test:

yes

Total exposure duration:

21 d

Test temperature:

19.48°C - 24.98°C

Moisture:

Relative humidity: 62.31% - 85.57%

Details on test conditions:

TEST SYSTEM
- Testing facility: Greenhouse conditions Bayer AG
- Test container: plastic flower pots (15 cm diameter)
- Method of seeding: manual introduction to soil, pressing of seeds into surface soil to complete coverage of layer soil (at the day of application)
- No. of seeds per container: BEAVA, BRSNW, CUMSA, GLXMA, HELAN, LYPES and ZEAMA: 2, ALLCE, AVESA and TRZAW: 4
- No. of replicates per treatment group: BEAVA, BRSNW, CUMSA, GLXMA, HELAN, LYPES and ZEAMA: 20, ALLCE, AVESA and TRZAW: 10
- No. of replicates per control: BEAVA, BRSNW, CUMSA, GLXMA, HELAN, LYPES and ZEAMA: 20, ALLCE, AVESA and TRZAW: 10

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: Riedberg, Frankfurt am Main, Germany
- Composition: “Riedberg” soil, washed sand (ratio 9/1) from Bayer AG, Horticulture und Services, Frankfurt, Germany and sieved to 2 mm
- sand: fine sand: 4.9%, middle sand: 20.3%, coarse sand: 6.1%
- silt: fine silt: 4.9%, middle silt: 17.8%, coarse silt: 28.9%
- clay: 17.1%
- Organic carbon: 0.72%
- Pretreatment of soil: Sterilisation by vapour pressure at 120°C for approximately 30 minutes

GROWTH CONDITIONS
- Photoperiod: 16 h light and 8 h dark
- Light source: artificial lighting
- Light intensity and quality: Natural daylight, 80.08 - 8883.55 lux
- Day/night temperatures: 19.48°C - 24.98°C
- Relative humidity: 62.31% - 85.57%
- Watering regime and schedules: Water was given and retained according to the need of the plants to maintain an optimal water supply for plant growth. The top soil was kept moist until the controls reached 50% of seedling emergence. The top soil was kept moist until the controls reached 50% of seedling emergence.
- Water source/type: Bottom watering with saucers standing below each pot
- Volume applied: 200 L/ha ±10%
- Method of application: One application at the beginning of the test by means of a linear cabinet track sprayer
- Any pest control mertilization: 2.4 g Blaukorn per liter

EFFECT PARAMETERS MEASURED:
- Emergence (day 0, 7, 15 and 21 post emergence of 50% of control seedlings)
- Survival ( (day 0, 7, 15 and 21 post emergence of 50% of control seedlings)
- Phytotoxicity (assessed according to EPPO Standard 135 on day 0, 7, 15 and 21 post emergence of 50% of control seedlings)
- Growth Stages (final assessment)
- Shoot length (final assessment)
- Shoot dry weight (final assessment)

- Phytotoxicity rating system: Phytotoxicity was recorded from the living plants at each assessment date following a 0-90% rating system in 10% steps. 0%: no injury or effect, 10, 20%: slight symptom, 30, 40%; moderate symptom, 50, 60%: severe symptom, 70, 80%: total plant symptom, 90%: moribund

Nominal and measured concentrations:

0, 200 g a.s./ha (nominal)
0, 0.2667 mg a.s./kg soil dw

Reference substance (positive control):

no

Species:

other: Beta vulgaris, Brassica napus, Cucumis sativus, Glycine max, Helianthus annuus, Solanum lycopersicum, Allium cepa, Avena sativa, Triticum aestivum, Zea mays

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 200 g/ha

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: emergence, survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight

Remarks on result:

other: Statistically significant reduction of 9.8% and 4.7%. However, no adverse effects on survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight above the 25% effect level were observed

Species:

other: Beta vulgaris, Brassica napus, Cucumis sativus, Glycine max, Helianthus annuus, Solanum lycopersicum, Allium cepa, Avena sativa, Triticum aestivum, Zea mays

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.267 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: emergence, survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight

Remarks on result:

other: Statistically significant reduction of 9.8% and 4.7%. However, no adverse effects on survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight above the 25% effect level were observed

Details on results:

200 g a.s./ha resulted in no adverse effects on emergence, survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight above the 25% effect level at the test item rate of 200 g a.s/ha.

Table 1: Effects of test item on emergence

Plant species	Control		Test item (200 ga.s./ha)
	Number of emerged plants	% emergence	Number of emerged plants	% emergence	% inhibition*	Statisticalsignificance
Beta vulgaris	35	87.5	37	92.5	-5.7	-
Brassica napus	39	97.5	35	87.5	10.3	-
Cucumis sativus	40	100	39	97.5	2.5	-
Glycine max	39	97.5	39	97.5	0.0	-
Helianthus annuus	38	95.0	38	95.0	0.0	-
Lycopersicon esculentum	39	97.5	38	95	2.6	-
Allium cepa	32	80.0	34	85.0	-6.3	-
Avena sativa	39	97.5	38	95.0	2.6	-
Triticum aestivum	38	95.0	40	100	-5.3	-
Zea mays	39	97.5	40	100	-2.6	-

*                Negative values indicate that there was an increase compared to the control

Statistical significance -:Inhibition is statistically not significant (Pairwise Mann-Whitney-U-test, one sided

smaller; p ≤ 0.05).

Table 2: Effects of test item on survival:

Plant species	Control		Test item (200 ga.s./ha)
	Number of survived plants	% survival	Number of survived plants	% survival	% inhibition*	Statisticalsignificance
Beta vulgaris	35	100	37	100	0.0	-
Brassica napus	39	100	35	100	0.0	-
Cucumis sativus	40	100	39	100	0.0	-
Glycine max	39	100	39	100	0.0	-
Helianthus annuus	38	100	38	100	0.0	-
Lycopersicon esculentum	38	97.4	38	100	-2.6	-
Allium cepa	29	90.6	34	100	-10.3	-
Avena sativa	39	100	38	100	0.0	-
Triticum aestivum	37	97.4	40	100	-2.7	-
Zea mays	39	100	39	97.5	2.5	-

*                Negative values indicate that there was an increase compared to the control

Statistical significance -:Inhibition is statistically not significant (Pairwise Mann-Whitney-U-test, one sided smaller; p ≤ 0.05).

Table 3: Effects of the test item on shoot length

Shoot Length
Plant Species	Mean control (cm)	Mean test item at200 g a.s./ha(cm)	% inhibition*	Statistical significance
Beta vulgaris	18.8	19.6	-4.2	-
Brassica napus	25.2	24.2	3.9	-
Cucumis sativus	23.1	22.6	2.1	-
Glycine max	40.3	40.8	-1.2	-
Helianthus annuus	12.3	13.2	-7.3	-
Lycopersicon esculentum	25.2	26.7	-6.1	-
Allium cepa	18.8	19.9	-6.3	-
Avena sativa	44.1	44.8	-1.8	-
Triticum aestivum	41.0	41.1	-0.1	-
Zea mays	104.7	104.1	0.6	-

*:         Negative values indicate that there was an increase compared to the control

Statistical significance -:Inhibition is statistically not significant (Pairwise Mann-Whitney-U-test, one sided smaller; p ≤ 0.05).

Table 4: Effects of the test item on shoot dry weight

Shoot Dry Weight
Plant Species	Mean control (g)	Mean test item at 200 g a.s./ha(g)	% inhibition*	Statistical significance
Beta vulgaris	0.715	0.701	2.0	-
Brassica napus	0.687	0.662	3.6	-
Cucumis sativus	0.944	0.932	1.2	-
Glycine max	1.402	1.366	2.6	-
Helianthus annuus	0.331	0.348	-5.4	-
Lycopersicon esculentum	0.943	1.066	-13.1	-
Allium cepa	0.029	0.040	-37.6	-
Avena sativa	0.241	0.246	-1.8	-
Triticum aestivum	0.385	0.376	2.3	-
Zea mays	3.260	3.304	-1.3	-

*:         Negative values indicate that there was an increase compared to the control

Statistical significance -:Inhibition is statistically not significant (Pairwise Mann-Whitney-U-test, one sided

smaller; p ≤ 0.05).

Validity criteria:

Table 3: Validity criteria for OECD 208.

Criterion	Outcome	Criterion fulfilled
Seedling emergence in the controls is ≥ 70%.	Emergence in the controls is ≥ 70% in each plant species	yes
No visible phytotoxic effects (e.g. chlorosis, necrosis, wilting, deformatons) in control seedlings and the plants of every particular species exhibit normal variation in growth and morphology.	No visible phytotoxic effects and normal variation in growth, plant development and morphology in control plants.	yes
The environmental conditions for a particular species are identical and the growing media contain the same amount of soil matrix, support media or substrate from the same source.	The environmental conditions during the test were identical within species. The pots were filled in equal manner with the same soil.	yes

Analytical results: The analysis of tetraniliprole content in the test item stock solution revealed measured concentrations of 100.1% - 100.5% of nominal.

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.

Description of key information

NOEC (21 d) ≥ 0.2667 mg/kg soil dw nominal (Beta vulgaris, Brassica napus, Cucumis sativus, Glycine max, Helianthus annuus, Solanum lycopersicum, Allium cepa, Avena sativa, Triticum aestivum, Zea mays, OECD 208 limit test)

Key value for chemical safety assessment

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

0.267 mg/kg soil dw

Additional information

Two GLP studies investigating the long-term toxicity of the substance are available. Both studies were conducted under controlled greenhouse conditions with ten crop plants species (6 dicotyledonous and 4 monocotyledonous species from 8 plant families) as limit tests with a single application rate of 200 g a.s./ha (corresponding to 0.267 mg a.s./kg soil dw).

In the key study (M-559339 -01 -1, according to OECD 208) seeds were sown in 15 cm pots on the day of the application of the test item to the soil surface by means of a laboratory track sprayer. Assessments were made individually for each species until 50% of the seedlings had emerged (= day 0) and after further 7, 14 and 21 days. In the controls of the ten species tested, growth was normal and no visible phytotoxicity occurred. Final assessment revealed no adverse or statistically significant effects on emergence, survival, visual phytotoxicity, growth stage development, shoot length and shoot dry weight.

In the second study (M-552710-01-1), a Vegetative Vigour Test according to OECD guideline 227 was performed. Seedlings were sown in silt loam and treated at the 2 – 4 leaf stage using a laboratory track sprayer. Final assessments were made for plant survival, visual phytotoxicity, plant growth stage shoot length and shoot dry weight after 21 days. No adverse effects above the 25% effect level were observed.Slight growth retardation and significant shoot dry weight and length reductions were observed in Lycopersicon esculentum only. All other plant species tested exhibited normal variation in the growth stage development as well as in shoot dry weight and length.