### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 1 of 20 Data Requirement: PMRA Data Code: 9.8.4 (TGAI) or 9.8.6 (EP)

EPA DP Barcode: 416757

OECD Data Point: IIA 8.12 (TGAI) and IIIA 10.8.1.1 (EP)

EPA Guideline: 850. 41 50

Test material: Nicosulfuron 75 WG Purity: 75.1 %

Common name :

Chemical name: I UPAC :

CAS name : 2

- [[[[(4,6

- Dimethoxy

- 2

- pyrimidinyl)amino]carbonyl]amino]sulfonyl]

- N,N

- dimethyl

- 3

- pyridinecarboxamide

CAS No. : 111991

- 09

- 4

Synonyms : DPX

- V9360 75WG, DPX

- V9360

- 119, Nicosulfuron (DPX

- V9360) 75WG

Primary Reviewer: Teresa Nelis Signatu re: Senior Scientist, CDM Smith Date: 12 / 13 /1 4

Secondary Reviewer: Teri S. Myers Signature:

Senior Scientist, CDM Smith Date: 04 / 03 /1 5

Primary Reviewer: Hannah Yingling Date: 10/14/2015

Biologist, EPA

CITA TION : Aufderheide, J.A. 2004. Nicosulfuron (DPX

- V9360) 75WG plus Isodecylalcohol Ethoxylated (IN

- KG691)

Surfactant: A Greenhouse Study to Investigate the Effects on Vegetative Vigor of Ten Terrestrial Plant Species

Following Foliar Exposure

. Unpublished st udy performed by ABC Laboratories, Inc., Columbia, MO. Performing

Laboratory Study Number: 48283 . Study sponsored by E.I. du Pont de Nemours and Company, Wilmington,

Delaware . Study completed November 15, 2004.

DISCLAIMER : This document provides guidance for EPA and PMRA reviewers on how to complete a data

evaluation record after reviewing a scientific study concerning the acute toxicity of a pesticide to terrestrial vascular

plants. It is not intended to prescribe conditions to any external party for co nducting this study nor to establish

absolute criteria regarding the assessment of whether the study is scientifically sound and whether the study satisfies

any applicable data requirements. Reviewers are expected to review and to determine for each study , on a case

- by

case basis, whether it is scientifically sound and provides sufficient information to satisfy applicable data

requirements. Studies that fail to meet any of the conditions may be accepted, if appropriate; similarly, studies that

meet all of the conditions may be rejected, if appropriate. In sum, the reviewer is to take into account the totality of

factors related to the test methodology and results in determining the acceptability of the study.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 2 of 20 EXECUTIVE SUMMARY :

The effect of Nicosulfu ron , ( DPX

- V9360, 75WG )

, on the vegetative vigor of monocot crops ( oat, Avena sativa ;
onion, Allium cepa ; sorghum, Sorghum bicol or ; wheat, Triti cum aesti vum ) and dicot crops ( cucumber, Cucumis

sativa; oilseed rape, Brassica napus ; pea, Pisum sativum

, s oybea n, Glycine max ; sugarbeet, Beta vulgaris ; and

tomato, Lycopersicon esculentum ) was studied at nominal concentration s of 0 (negative), 0.000 10, 0.00021,

0.00042

, 0.000 83, 0.0017 , 0.00 33 , 0.00 67 , 0.0 13 , 0.0 27

, a nd 0.053 lb as/ A. Measured application rate fo r the

highest concentration was reported and ranged from 0.0 47 to 0.055 lb as/A

.

The growth medium used in the vegetative vigor test was an artificial greenhouse soil mixture for oat, onion,

sorghum, cucumber, oilseed rape, sugarbeet, and tomato (loamy s and, pH 7.0, organic matter 2.7% ) and for pea,

soybean, and wheat (loamy sand, pH 7.0, organic matter 2.7%) . On day 21 the surviving plants per pot were

recorded, and plant height and dry weight were measured.

Negative control survival was 100 % for all species . Based on the study author results, there was significant inhibition

in survival of cucumber and oat at the highest treat ment level , 0.055 lb as/A ( p<0.05; Dunnett’s test ). The reviewer

found that the 35% inhibition in survival of cucumber at the h ighest treatment level was significant, but the 2 0%

inhibition in survival of oat at the highest treatment level was not significant (p<0.05 ; Mann

- Whitney U Two

- Sample

test )

.

The reviewer found an inhibition in height for all s pecies except soybean . The r e were signif icant inhibitions in height

at maximum inhibitions of 53, 68, 65, 37 , 56, 47, 20, and 42% for cucumber, oat, oilseed rape, onion, sorghum,

sugarbeet, tomato and wheat , respectively compared to the negative control and responses were dose

- depen dent

(p<0.05; Williams test). The reviewer also found significant inhibition in height of up to 40% for pea at the highest

treatment level, 0.55 lb as/A, however the response was not dose

- dependent (p<0.0 5; Dunnett’s test).

The reviewer also found si gnificant inhibitions in dry weight in all species except soybean . Th ere were significant

inhibitions in dry weight w ith maximums of up to 75, 86, 93, 49, 58, 71, 69 and 87% for cucumber, oat, oilseed rape,

onion, sorghum, sugarbeet, tomato and wheat, res pectively

, compared to the negative control and responses were

dose

- dependent (p<0.05; Williams test). T he reviewer also found significant inhi bition in dry weight of 32% for pea

at the highest treatment level, 0.055 lb as/A, however, the effect was not do se

- dependent (p <0.05; Dunnett’s test).

The occurrence of phytotoxic effects increased in severity and prevalence with increasing test concentrations;

symptoms included discoloration, leaf deformation, compressed growth and necrosis . Mean effects were max imums

of 18 to 100% over all the species tested; oilseed rape and cucumber had the most significant effects of 18 and 20%,

respectively (100 indicates normal seedling, 0 indicates complete mortality). Effects were dose

- related.

T he most sensitive monoco t species was sorghum based on dry weight, with NOEC and IC 25 values of 0.0033 and

0.00613 lb as /A, respectively

. The most sensitive dicot species was oilseed rape based on dry weight , with NOEC

and I C 25 values of 0.00083 and 0.00208 lb as /A, respectively

.

Maximum Labeled Rate: 0.053 lb as /A (equivalent to 60 g as /ha).

Most sensitive monocot: Sorghum, based on dry weight

EC 50 /IC 50 : 0.0249 lb as /A 95% C.I.: 0.0196

- 0.0315 lb as /A

EC 25 /IC 25 : 0.00613 lb as /A 95% C.I.: 0.00417

- 0.00862 lb as /A

EC 05 /IC 05 : 0.000817 lb as /A 95% C.I.: 0.000133

- 0.00162 lb as /A

NOEC: 0.0033 lb as /A

Slope: N/A 95% C.I.: N/A

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 3 of 20 Most sensitive dicot: Oilseed Rape, based on dry weight

EC 50 /IC 50 : 0.00495 lb as A 95% C.I.: 0.00424

- 0.00579 lb as /A

EC 25 /IC 25 : 0.0 0208 lb as /A 95% C.I.: 0.00163

- 0.00258 lb as /A

EC 05 /IC 05 : 0.000595 lb as /A 95% C.I.: 0.000154

- 0.000925 lb as /A

NOEC: 0.00083 lb as /A

Slope: N/A 95% C.I.: N/A

Table 1 (Tier II studies). Summary of most sensiti ve parameters by species (l bs as /A).

Species Endpoint NOEC EC 05 / I C 05 EC 25 / I C 25 EC 50 / I C 50

Cucumber Dry weight 0.00 17 0.000 369 0.00 262 0.0102

Oat Dry weight 0.0 067 0. 00537 0. 0114 0. 0192

Oil seed Rape Dry weight 0.00 083 0.00 0595 0.00 208 0 .00495

Onion Dry weight 0.0067 0. 00645 0. 0235 0.0577

Pea Height 0.0 27 0.0 247 0. 0439 0.0655

Sorghum Dry weight 0. 00 33 0.000817 0.00613 0.0249

Soybean None 0. 055 >0.055 >0.055 >0.055

Sugarbeet Dry weight 0.00 33 0.00 186 0.00 764 0.0 204

Tomato Dry weight 0.0017 0.00 0532 0.00 384 0.0152

Wheat Dry weig ht 0.0067 0.00433 0.0105 0.0194

This study is scientifically sound and is classified as acceptable

.

I. MATERIALS AND METHODS

GUIDELINE FOLLOWED: The methods used in conducting this study were based on procedures

specified in the U.S. EPA Series 850

– Ecological Effects Test Guidelines

OPPTS Number 850.4 2 50 (1996) . Deviations from OPPTS 850.4 2 50 were

noted

.

1. The physico

- chemical properties of the test material were not reported

.

The deficiency and d eviations did not have an impact on the acceptabi lity of this study.

COMPLIANCE: Signed and dated GLP, Quality Assurance and No Data Confidentiality

statements were provided. This study was conducted in compliance with

FIFRA Good Laboratory Practice Standards as published by the U .S. EPA,

40 CFR Par t 160 (1989) and the OECD Principles of Good Laboratory

Practice (ENV/MC/CHEM (98)17).

A. MATERIALS:

1. Test Material Nicosulfuron ( DPX

- V9360) 75WG plus Isodecylalcohol Ethoxylated

(IN

- KG691) Surfactant; formulation containing 75.1% as

Description : Solid powder

Lot No./Batch No. : APR02EL025 / DPX

- V9630

- 119

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 4 of 20 Purity: 75.1 %

Stability of compound

under test conditions: Analytical recovery of test substance from the spray solution s used in the

four test application dates of November 5, No vember 20, December 16 and

February 12 was 99.4

- 103.8%, 78.1

- 97.5%, 106.3

- 111.9% and 101.9

- 103.1%, respectively, (n=8) at a nominal concentration of 0.053 lb as/A.

The certificat e of analysis reported that 100 % of the test material remains in

the delivery vehicle after 1 hour under agitation.

(OECD recommends chemical stability in water and light )

Storage conditions of

test chemicals: T he test material was stored under ambient conditions

.

Table 2. Physical/chemical properties of Nicosulfuron (DPX

- V9360)

.

Parameter Values Comments

Water solubility at 20  ̊ C Not reported

Vapor pressure Not reported

UV absorption Not reported

pKa Not reported

Kow Not reported

2. Test organism :

Monocotyledon ous species: O at ( Avena sativa

, Gramineae ; Ogle ) , O nion ( Allium cepa

, Liliaceae; Yellow

Granex Hybrid ) , S orghum ( Sorghum bicolor

, Gramineae ; Pioneer 8313

- 2103 ) , and W heat ( Triticum

aesti vum

, Gramineae ; Sisson )

. EPA recommends four monocots in two families, including corn.

Dicotyledonous species: Cucumber ( Cucumis sativa , Cucurbitaceae; Straight Eight), Oilseed Rape

( Brassica napus , Brassicaceae; Wichita ), Pea ( Pisum sativum

, Leguminosae ; Little Marvel)

, Soybean

( Glycine max , Leguminosae ; Williams B2 ), Suga rbeet ( Beta vulgaris , Chenopodiaceae; 1309R), and

Tomato ( Lycopersicon esculentum , Solanaceae; Beefsteak )

. EPA recommends six dicots in four families,

including soybean and a root crop.

OECD recommends a minimum of three species selected for testing, at least one from each of the following categories:

Category 1: ryegrass, rice, oat, wheat, and sorghum; Category 2: mustard, rape, radish, turnip, and Chinese cabbage;

Category 3: vetch, mung bean, red clover, fenugreek, lettuce, and cress.

Seed source: Cuc umber, Onion, Pea and Tomato obtained from Chesmore Seed Company; Oat obtained

from Illinois Foundation Seed; Oilseed Rape obtained from Kansas State University Department of

Agronony; Sorghum obtained from Syngenta Seeds; Soybean obtained from Missouri F o undation Seeds;

Sugarbeet obtained from Betaseed; and Wheat obtained from Virginia Crop Improvement Association.

Prior seed treatment/sterilization: It was not stated if the seeds were treated with any type of f ungicides,

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 5 of 20 insecticides, or pesticides.

Histo rical % germination of seed: C ucumber, 85 %; oat, 97%; oilseed rape, 95%; onion, 82 %; pea, 81%;

sorghum, 85%; soybean, 88%; sugarbeet, 96%; tomato, 80 %; and wheat, 94%.

Seed storage, if any: Not reported.

B. STUDY DESIGN:

1. Experimental Conditions :

a. Limit test: None.

b. Range

- finding study : None

.

c. Definitive Study

Table 3: Experimental Parameters

– Vegetative Vigor

.

Parameters Vegetative Vigor

Details Remarks

Criteria

Duration of the test 21 days

Recommended te st duration is 14

- 21 days.

OECD recommends that the test be terminated no

sooner than 14 days after 50 percent of the control

seedlings have emerged

Number of

seeds/plants/species/

replicate Five pots (replicates) with 4 seeds

per pot

. Five plants p er replicate are recommended.

Number of plants retained

after thinning Thinned to one seed per pot prior

to application ; Application at 1

- 4

leaf stage.

Number of replicates

Control:

Adjuvant control:

Treated: 5

N/A

5 Four r eplicates per dose should be used.

OECD recommends a minimum of four replicates

per treatment

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 6 of 20 Parameters Vegetative Vigor

Details Remarks

Criteria

Test concentrations (lb

as /A)

Nominal:

Measured: 0 (negative), 0.00010, 0.00021,

0.00042, 0.00083, 0.0017, 0.0033,

0.0067, 0.013, 0.027, and 0.053 lb

as/ A

.

Highest treatment concentration

was measured and ranged from

0.047 to 0.055 lb as/A. Five test concentrations should be used with a dose

range of 2X or 3X progression

OECD recommends three concentrations,

preferably with a

pplication rates equivalent to 0.0

(control), 1.0, 10.0 and 100 mg substance per kg of

oven

- dried soil.

Method and interval of

analytical verification

LOQ:

LOD: Concentration of DPX

- V9360

- 119

in the negative control and highest

treatment solution w as de termined

by HPLC using an Agilent G1300

Series HPLC equipped wi th an

Agilent G1314A UV detector and

a Discovery Cl 8 column (150 mm

x 4.6 mm I.D.).

0.000021 lb as/A

N/A

Adjuvant (type, percentage,

if used) N/A

Test container (pot)

Size/Volume

Material:

(glass/polystyrene) Onion pot was 10 cm diameter

and 7 cm deep; all other species,

15 cm diameter and 10 cm deep

. Plastic Non

- porous containers should be used.

OECD recommends that non

- porous plastic or

glazed pot b e used.

Growth facility Greenhouse

Method/depth of seeding Plants were thinned prior to

application. Cucumber, oat, p ea, sorghum, soybean and wheat

seeds were planted 20 mm below

the surface and oilseed rape,

onion, sugarbeet and tomato seeds

were plan t ed 6 mm deep.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 7 of 20 Parameters Vegetative Vigor

Details Remarks

Criteria

Test material application

Application time including

the plant growth stage

Number of application s

Application interval

Method of application Application at the 1

- 4 true leaf

growth stage.

1

N/A

- single application

The test materi al was applied

using a Devries Research Track

S prayer (4004 E Tee

- Jet nozzle)

, 40 psi; 72 cm above the soil

surface

.

Details of soil used

Geographic location

Depth of soil collection

Soil texture

% sand

% silt

% clay

pH:

% organic carbon

CEC

Moistur e at 1/3 atm (%)

Geographic location

Depth of soil collection

Soil texture

% sand

% silt

% clay

pH:

% organic carbon

CEC

Moisture at 1/3 atm (%) For oat, onion, sorghum,

cucumber, oilseed rape, sugarbeet,

and tomato :

N/A

N/A

Silt loam

22

56

22

7. 0

N/A

20.8 meq/100g

30.1 %

for pea, soybean, and wheat :

N/A

N/A

Silt loam

15

64

21

7.0

N/A

17.3

29.1 Organic matter: 2.7 %

Organic Matter: 2.5%

Soil mixes containing sandy loam, loam, or clay

loam soil with no greater than 2% organic matter

are preferable. Glass beads, rock wool, and 100%

acid washed sand are not preferred.

OECD prefers the soil to be sieved (0.5 cm) to

remove coarse fragments. Carbon content should

not exceed 1.5% (3% organic matter). Fine particles

(unde r 20um) makeup should be between 10 and

20%. The recommended pH is between 5.0 and 7.5.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 8 of 20 Parameters Vegetative Vigor

Details Remarks

Criteria

Details of nutrient medium,

if used N/A

Watering regime and

schedules

Water source/type:

Volume applied:

Interval of application:

Method of application: Well water demineralized by

reverse osmosis

. Nominal spray volume was 375

L/h a; calibrations of sprayer

system indicated actual spraying

rates of 369

- 380 L/ha.

One application per species.

The plants were bottom watered. EPA prefers that bottom watering be utilized for

seedling emergence studies so that the chemical is

not leached out of the soil during the test.

Any pest control

method/fertilization, if used None reported

Test conditions

Temperature:

Photoperiod:

Light intensity and quality:

Relative humidity:

Temperature:

Photoperiod:

Light intensity and quality:

Relative humidity:

Temperature:

Photoperiod:

Light intensity and quality:

Relative humidity:

Temperature: Cucumber and Tomato

21.7

- 26.7  ̊C (day)

12.6

- 21.7  ̊C (night)

16L:8D

Natural light supplemented with

high intensity grow lights.

104.3

- 771.8 uEins/m2 /s

4 3

- 72 % (day)

Oilseed Rape and Sugarbeet

21.7

- 27.9 ̊C (day)

16.0

- 23.6 ̊C (night)

16L:8D

Natural light supplemented with

high intensity grow lights.

121.9

- 753.0 uEins/m2 /s

32

- 74% (day)

Oat and Sorghum

22.5

- 32.3 ̊C (day)

16.4

- 21.7 ̊C (night)

16L:8D

Natural light supplemented with

high intensity grow lights.

77.34

- 509.4 uEins/m2 /s

29

- 70% (day)

Onion

26.3

- 31.5 ̊C (day)

11.4

- 23.2 ̊C (night)

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 9 of 20 Parameters Vegetative Vigor

Details Remarks

Criteria

Photoperiod:

Light intensity and quality:

Relati ve humidity:

Temperature:

Photoperiod:

Light intensity and quality:

Relative humidity: 16L:8D

Natu ral light supplemented with

high intensity grow lights.

208.0

- 519.7 uEins/m2 /s

16

- 52% (day)

Pea, Soybean and Wheat

22.1

- 32.8 ̊C (day)

17.5

- 24.4 ̊C (night)

16L:8D

Natural light supplemented with

high intensity grow lights.

151.6

- 563.3 uEins/m2 /s

26

- 63% (day) EPA prefers that the cold vs warm loving plants be

tested in two separate groups to optimize plant

growth.

OECD prefers that the temperature, humidity and

light conditions be suitable for maintaining normal

growth of each specie s for the test period.

Reference chemical (if

used)

Name:

Concentrations: DPX

- V9360 Lot 116

97.9% purity

Other parameters, if any None

2. Observations:

Table 4: Observation Parameters

– Vegetative Vigor

.

Parameters Vegetative Vigor

Details Remarks

Parameters measured (e.g., number

of germinated seeds, emerged

seedlings, plant height, dry weight

or other endpoints) - Survival

- Height

- Total d ry weight

- Phytotoxicity

Measurement technique for each

parameter P hytotoxicity w as visually

determined. Survival was

defined as the percent of

emerged. Height was

measured. Mean plant

weight was estimated by

measuring the total dry

weight following oven

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 10 of 20 drying ( 60 to 80 o C for at

least 48 hours)

.

Observation intervals Each pot was inspecte d

weekly and phytotoxicity

assessments performed.

Shoot height and dry

weight were recorded at

study termination.

Other observations, if any N/A

Were raw data included? Yes

Phytotoxicity rating system, if used 0

- Complete mortality;

100

– normal see dling

. Frans, Robert E. and Ronald E. Talbert. 1977.

Design of Field Experiments and the

Measurement and Analysis of Plant Responses

,

pp. 15

- 23

, in B. Truelove, ed.

, Research

Methods in Weed Science. Southern Weed

Science Society, Auburn University, Alabam a.

II. RESULTS and DISCUSSION:

A. INHIBITORY EFFECTS:

1. Vegetative Vigor :

Negative control survival was 100 % for all species . Based on the study author results, there was significant

inhibition in survival of cucumber and oat at the highest treatment level, 0.055 lb as/A (p<0.05; Dunnett’s

test). The reviewer found that the 35% inhibition in survival of cucumber at the highest treatment level was

significant, but the 2 0% inhibition in survival of oat at the highest treatment level was not significant

(p<0.05; Mann

- Whitney U Two

- Sample test).

The study author and reviewer found an inhibition in height for all species except soybean. The reviewer

found significant inhibitions in height at maximum inhibitions of 53, 68, 65, 37, 56, 47, 20, and 42% for

c ucumber, oat, oilseed rape, onion, sorghum, sugarbeet, tomato and wheat, respectively compared to the

negative control and responses were dose

- dependent (p<0.05; Williams test). The reviewer also found

significant inhibition in height of up to 40% for pea at the highest treatment level, 0.55 lb as/A, however the

response was not dose

- dependent (p<0.05; Dunnett’s test).

The study author and reviewer also found significant inhibitions in dry weight in all species except soybean.

The reviewer found signi ficant inhibitions in dry weight were maximums of up to 75, 86, 93, 49, 58, 71, 69

and 87% for cucumber, oat, oilseed rape, onion, sorghum, sugarbeet, tomato and wheat, respectively,

compared to the negative control and responses were dose

- dependent (p<0.0 5; Williams test). The reviewer

also found significant inhibition in dry weight of 32% for pea at the highest treatment level, 0.055 lb as/A,

however, the effect was not dose

- dependent (p<0.05; Dunnett’s test).

The occurrence of phytotoxic effects increa sed in severity and prevalence with increasing test

concentrations; symptoms included discoloration, leaf deformation, compressed growth and necrosis. Mean

effects were maximums of 18 to 100% over all the species tested; oilseed rape and cucumber had the m ost

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 11 of 20 significant effects of 18 and 20%, respectively (100 indicates normal seedling, 0 indicates complete

mortality). Effects were dose

- related.

Based on the study authors results, t he most sensitive monocot species was wheat based on dry weight, with

NO EC and I R 50 values of 0.00 67 and 0.0 19 lb as /A, respectively

. The most sensitive dicot species was

oilseed rape based on dry weight , with NOEC and I R 50 values of 0.00083 and 0.00 55 lb as /A, respectively

.

B. REPORTED STATISTICS:

S urvival, dry weigh t, and height means and standard deviations were determined for control and treatment groups

. NO EC values were determined using Dunnett’s trend test

. All statistical determinations were made with 95%

certainty. Estimates of the E R x values and their confidenc e limits for dry weight and growth height were determined

by non

- linear regression analysis using a four

- parameter logistic (sigmoid

- shaped) model with two parameters fixed

(100 and 0% inhibition). A probit analysis developed by Finney (1971) was used in t he non

- linear regression

analysis of survival data. These analyses wer e conducted using SAS, version 6.12 (199 6)

. Nominal concentrations

were used for all analyses. Study authors calculated survival based on number planted.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 12 of 20 Table 5: Effect of Nicosulf uron (DPX

- V9360) on 21

- Day Vegetative Vigor

Species Results summary for biomass (lbs a s /A) *

weight (g) NOEC I C 5 95%CI I C 25 95%CI I C 50 95%CI slope 95%CI

Cucumber 1.83

- 7.68 0.0017 ND N/A 0.0032 0.0021

- 0.0042 0.0096 0.0073

- 0.0119 N/A N/A

Oat 0.229

- 1.82 0. 0067 ND N/A 0.0125 0.0099

- 0.0152 0.0194 0.0165

- 0.0224 N/A N/A

Oilseed Rape 0.458

- 6.89 0.00083 ND N/A 0.0030 0.0026

- 0.0035 0.0055 0.0049

- 0.0061 N/A N/A

Onion 0.116

- 0.229 0.013 ND N/A 0.0227 0.0182

- 0.0273 0.0525 0.0413

- 0.0638 N/A N/A

Pea 2.77

- 4.17 0.027 ND N/A 0.0477 0.0360

- 0.0594 > 0.053 N/A N/A N/A

Sorghum 0.175

- 0.42 0.0033 ND N/A 0.0052 0.0032

- 0.0072 0.0234 0.0157

- 0.0311 N/A N/A

Soybean 8.0

- 8.86 0.053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

S ugarbeet 1.34

- 4.86 0.0033 ND N/A 0.0079 0.0059

- 0.0099 0.0190 0 .0154

- 0.0226 N/A N/A

Tomato 1.52

- 5.57 0.0033 ND N/A 0.0060 0.0034

- 0.0086 0.0180 0.0122

- 0.0238 N/A N/A

Wheat 0.36

- 2.71 0.0067 ND N/A 0.0104 0.0078

- 0.0130 0.0186 0.0154

- 0.0220 N/A N/A

N D

- No t determined . NC

- Not calculable.

* NOEC determined using Dunnett ’s trend test (p<0.05); I C 25 and I C 50 and their 95% confidence intervals estimated using non

- linear regression

analysis.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 13 of 20 Table 5a: Effect of Nicosulfuron (DPX

- V9360) on 21

- Day Vegetative Vigor

Species Results summary for height (lbs a s/ A) *

height

(m m ) NOEC I C 5 95%CI I C 25 95%CI I C 50 95%CI slope 95%CI

Cucumber 62

- 156 0.0067 ND N/A > 0.053 N/A >0.053 N/A N/A N/A

Oat 167

- 534 0.0067 ND N/A 0.0166 0.0141

- 0.0191 0.0299 0.0266

- 0.0331 N/A N/A

Oilseed Rape 70.6

- 224 0.0067 ND N/A 0.0088 0.0064

- 0.0113 0.0196 0 .0157

- 0.0235 N/A N/A

Onion 115

- 184 0.013 ND N/A 0.0340 0.0273

- 0.0407 >0.053 N/A N/A N/A

Pea 182

- 301 0.027 ND N/A 0. 0416 0.0354

- 0.0478 > 0.053 N/A N/A N/A

Sorghum 109

- 247 0. 0033 ND N/A 0.0068 0.0050

- 0.0085 0.292 0.0221

- 0.0362 N/A N/A

Soybean 282

- 317 0. 0 53 ND N/A >0.053 N/A >0.053 N/A N/A N/A

S ugarbeet 106

- 200 0.00 33 ND N/A 0.0136 0.0112

- 0.0159 >0.053 N/A N/A N/A

Tomato 96

- 130 0.0 13 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Wheat 225

- 389 0. 0067 ND N/A 0.0163 0.0130

- 0.0195 >0.053 N/A N/A N/A

N D

- No t determi ned . NC

- Not calculable.

* NOEC dete rmined using Dunnett’s trend test (p<0.05); I C 25 and I C 50 and their 95% confidence intervals estimated using non

- linear regression

analysis.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 14 of 20 Table 5b: Effect of Nicosulfuron (DPX

- V9360) on 21

- Day Veget ative Vigor

Species Results summary for survival ( lbs a s /A ) , based on # planted *

% NOEC E C 5 95%CI EC 25 95%CI EC 50 95%CI slope 95%CI

Cucumber 65

- 100 0. 027 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Oat 80

- 100 0. 027 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Oilsee d

Rape 95

- 100 0. 053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Onion 100 0. 053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Pea 100 0. 053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Sorghum 100 0. 053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Soybean 100 0. 053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

S ugarbeet 90

- 100 0. 053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Tomato 100 0. 053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

Wheat 100 0. 053 ND N/A >0.053 N/A >0.053 N/A N/A N/A

N D

- No t determined . NC

- Not calculable.

* NOEC determined using Du nnett’s trend test (p<0.05); E C 25 and E C 50 and their 95% confidence intervals estimated using non

- linear regression

analysis.

Plant Injury Index *

Control C ucumber Oat O ilseed

R ape Onion Pea Sorghum Soybean Sugarbeet Tomato Wheat Formulation

Blank

90

- 10 0 20

- 92 3 0

- 100 18

- 100 80

- 100 78

- 100 5 0

- 100 96

- 100 24

- 100 5 0

- 100 32

- 100 N/A

* 0

- complete mortality, 100

– no effect.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 15 of 20 C. VERIFICATION OF STATISTICAL RESULTS BY THE REVIEWER:

All analyses were conducted comparing treated to the negative control. These analyses were conducted using

CETIS version 1.8.7. 12 and backend settings approved for use by EFED on 3 / 25 /1 4

. Data for each endpoint

were tested to determine if their distributions were normal and if their variances were homogeneous using

Shapiro

- Wilk’s and Levene’s tests, respectively. Data that satisfied these assumptions were subjected to

Dunnett’s and William’s tests, and data that did not satisfy these assumptions were subjected to the non

parametric MannWhitney

- U and Jonckheere’s tests. Nomi nal concentra tions we re used for all analyses except

the highest treatment level. Linear (survival and emergence) and nonlinear (height and dry weight) regression

models were used to interpret EC/ICx values.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 16 of 20 Table 6: Effect of Nicosulfuron (DPX

- V9360) on 21

- Day Vegetative Vigor

Species Results summary for biomass (lbs a s /A)

weight (g) NOEC I C 5 95%CI I C 25 95%CI I C 50 95%CI slope 95%CI

Cucumber 1 1.83

- 7.68 0.0017 0.0003 69 1.82 x10

- 5

- 0.0007 6 0.00 26 2 0.00 18

- 0.00 36 4 0.0 102 0.00 824

- 0.0 126 N/A N/A

Oat 2 0.229

- 1.82 0.0067 0.00 537 0.00175

- 0.00 709 0.011 4 0.00921

- 0.013 6 0.019 2 0.017

- 0.02 16 N/A N/A

Oilseed

Rape 3 0.458

- 6.89 0.00 083 0.000 595 0.000154

- 0.0009 25 0.002 08 0.00163

- 0.002 58 0.0049 5 0.00424

- 0.00579 N/A N/A

Onion 4 0.116

- 0.229 0.0067 0.00 645 0.00236

- 0.0 0982 0 .0235 0.0189

- 0.028 6 0.05 77 0.0477

- 0.06 99 N/A N/A

Pea 5 2.77

- 4.17 0.027 0.0287 N / A

- 0.04 5 0.0 501 0.0397

- 0.0 601 0.07 38 0.0433

- 0.12 6 N/A N/A

Sorghum 6 0.175

- 0.42 0.0033 0.000 817 0.000133

- 0.001 62 0.00 613 0.00417

- 0.008 62 0.02 49 0.0196

- 0.03 15 N/A N/A

Soybean 8.0

- 8.86 0.05 5 >0.05 5 N/A >0.05 5 N/A >0.05 5 N/A N/A N/A

S ugarbeet 7 1.34

- 4.86 0.0033 0.00186 0.000617

- 0.00295 0.00764 0.00574

- 0.00983 0.0204 0.0174

- 0.0239 N/A N/A

Tomato 8 1.52

- 5.57 0.0017 0.000532 N/A

0.00117 0.00384 0.00245

- 0.00567 0.0152 0.0118

- 0.0195 N/A N/A

Wheat 9 0.36

- 2.71 0.0067 0.004 33 N/A

0.006 08 0.010 5 0.00816

- 0.013 0.0194 0.0168

- 0.022 5 N/A N/A

N D

- No t determined . NC

- Not calculable.

1 Signific ant decrease in cucumber w eight, inhibition of 29 to 75 % beginning at the 0.0033 lb a s /A treatment compare d to the negative control

( Williams test , p<0.05 ).

2 Significant decrease in oat weight, inhibitions of 33, 69 and 86 % at the 0.013, 0.027 and 0.047 lbs as /A treatment s compared to the negative

control (Williams test, p<0.05).

3 Significant decrease in oil seed rape weight, inhibition of 27 to 93 % beginning at 0.0033 lb a s/A treatment compared to the negative control

( Williams test, p<0.05).

4 Significant decrease in onion weight, inhibition of 12, 32 and 49 % at the 0.013, 0.027 and 0.057 lb as /A treatments com pared to the negative

control ( Williams test , p<0.05).

5 Significant decrease in pea weight, inhibition of 32 % at 0. 055 lbs as /A treatment compared to the negative control ( Dunnett’s test , p<0.05).

6 Significant decrease in sorghum weight, inhibitions of 24 to 58 % beginning at the 0.0067 lbs as /A treatment compared to the negative control

( Williams test, p<0 .05).

7 Sig nificant decrease in sugarbeet w eight, inhibition of 1 8 to 71 % beginning at the 0.00 67 lb as/A treatment compared to the negative contro l

(Williams test, p<0.05).

8 Significant decrease in tomato w eight, inhibition of 1 9 to 69 % beginning at the 0.00 33 lb as /A treatment compared to the negative control

( Williams test , p<0.05).

9 Significant decrease in wheat weight, inhibition of 37, 67 and 87 % at the 0.013, 0.027 and 0 .055 l b as /A treatments compared to the negative

control ( Williams test, p<0.05 ).

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 17 of 20 Table 6a: Effect of Nicosulfuron (DPX

- V9360) on 21

- Day Vegetative Vigor

Species Re sults summary for height (lbs as /A)

height

(m m) NOEC I C 5 95%CI I C 25 95%CI I C 50 95%CI slope 95%CI

Cucumber 1 62

- 156 0.0067 >0.0067 N/A >0.0067 N/A >0.0067 N/A N/A N/A

Oat 2 1 67

- 534 0.0067 0. 00647 0.00426

- 0.00815 0.0156 0.0134

- 0.0178 0.0286 0.0265

- 0.0309 N/A N/A

Oilseed Rape 3 70.6

- 224 0.0067 0.00144 0.000384

- 0.0 024 0.00671 0.0049

- 0.00886 0.0196 0.0165

- 0.0234 N/A N/A

Onion 4 115

- 184 0.013 0.00776 0.00301

- 0.012 0.032 0.0261

- 0.0386 0.0858 0.0619

- 0.119 N/A N/A

Pea 5 182

- 301 0.027 0.0247 N/A

0.0325 0.0439 0.0378

- 0.0498 0.0655 0.056

- 0.0766 N/A N/A

Sorghum 6 109

- 247 0.0 0021 0.00123 0.00053

- 0.002 0.00819 0.00636

- 0.0103 0.0306 0.0257

- 0.0364 N/A N/A

Soybean 282

- 317 0.055 >0.055 N/A >0.055 N/A >0.055 N/A N/A N/A

S ugarbeet 7 106

- 200 0.0033 0.0025 0.00146

- 0.00362 0.0163 0.0137

- 0.0191 0.0599 0.0496

- 0.0723 N/A N/A

Tomato 8 96

- 1 30 0.0033 0.00236 0.000642

- 0.00524 0.0738 0.0356

- 0.14 0.808 0.123

- 5.31 N/A N/A

Wheat 9 225

- 389 0.0 06 7 0.00205 0.000984

- 0.00324 0.0159 0.0129

- 0.0195 0.0663 0.051

- 0.0862 N/A N/A

N D

- No t determined . NC

- Not calculable.

1 Significant decrease in cucumber h eig ht, inhibition of 4 9 , 52 and 53 % at 0.01 3 , 0.027 and 0.055 lb as/A treatment compared to the negative

control (Williams test, p<0.05).

2 Significant decrease in oat h eight, inhibitions of 14, 54 and 68 % at the 0.013, 0.027 and 0.047 lbs as/A treatments com pared to the negative

control (Williams test, p<0.05).

3 Significant decrease in oilseed rape h eight, inhibition of 54, 62 and 65% at 0.013, 0.027 and 0.055 lb as/A treatment compared to the negative

control ( Jo n c kheere

- Terpstra Step

- Down test, p<0.05).

4 Significant decrease in onion h eight, inhibition of 23 and 37 % at the 0.027 and 0.057 lb as/A treatments compared to the negative control

(Williams test, p<0.05).

5 Significant decrease in pea h eight, inhibition of 40 % at 0.055 lbs as/A treatment compare d to the negative control (Dunnett’s test, p<0.05).

6 S ignificant decrease in sorghum h eight, inhibitions of 11 to 56% beginning at the 0.00042 lbs as/A treatment compared to the negative control

(Williams test, p<0.05).

7 Significant decrease in su garbeet height, inhibition of 13 to 47% beginning at the 0.0067 lb as/A treatment compared to the negative control

(Williams test, p<0.05).

8 Significant decrease in tomato height, inhibition of 12 to 20% beginning at the 0.0067 lb as/A treatment compared to the negative control

(Williams test, p<0.05).

9 Significant decrease in wheat h eight, inhibition of 25, 42 and 42 % at the 0.013, 0.027 and 0.055 lb as/A treatments compared to the negative

control (Williams test, p<0.05).

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 18 of 20 Table 6b: Effect of Nicosulfuron ( DPX

- V9360) on 21

- Day Vegetative Vigor

Species Results summary for survival ( lbs a s /A ) , based on # planted

% NOEC EC 5 95%CI EC 25 95%CI EC 50 95%CI slope 95%CI

Cucumber 1 65

- 100 0.027 >0.027 N/A >0.027 N/A >0.027 N/A N/A N/A

Oat 80

- 100 0.047 NC N/A >0.047 N/A >0.047 N/A N/A N/A

Oilseed

Rape 95

- 100 0.055 >0.055 N/A >0.055 N/A >0.055 N/A N/A N/A

Onion 100 0.057 >0.057 N/A >0.057 N/A >0.057 N/A N/A N/A

Pea 100 0.055 >0.055 N/A >0.055 N/A >0.055 N/A N/A N/A

Sorghum 100 0.047 >0.047 N/A >0.047 N/A >0.047 N/A N/A N/A

Soybean 100 0. 055 >0.055 N/A >0.055 N/A >0.055 N/A N/A N/A

S ugarbeet 90

- 100 0.0 55 NC N/A >0.055 N/A >0.055 N/A N/A N/A

Tomato 100 0.0 55 >0.055 N/A >0.055 N/A >0.055 N/A N/A N/A

Wheat 100 0.055 >0.055 N/A >0.055 N/A >0.055 N/A N/A N/A

N D

- No t determined . NC

- Not calculable.

1 Significant decrease in cucumber survival, inhibition of 35% at 0.055 lb as/A treatment compared to the negative control (Man n

- Whitney U Two

Sample test, p<0.05).

Plant Injury Index*

Control Cucumber Oat Oilseed

Rape On ion Pea Sorghum Soybean Sugarbee t Tomato Wheat Formulation

Blank

90

- 100 20

- 92 30

- 100 18

- 100 80

- 100 78

- 100 50

- 100 96

- 100 24

- 100 50

- 100 32

- 100 N/A

* 0

- complete mortality; 100 = normal seedling.

Most sensitive monocot: Sorghum, based on dry weigh t

EC 50 /IC 50 : 0.0 249 lb as /A 95% C.I.: 0. 0196

- 0.0315 lb as /A

EC 25 /IC 25 : 0. 00613 lb as /A 95% C.I.: 0 .00417

- 0.00862 lb as /A

EC 05 /IC 05 : 0.0 00817 lb as /A 95% C.I.: 0.000133

- 0.00162 lb as /A

NOEC: 0. 0033 lb as /A

Slope: N/A 95% C.I.: N/A

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 19 of 20 M ost sensitive dicot: Oilseed Rape, based on dry weight

EC 50 /IC 50 : 0.00495 lb as A 95% C.I.: 0.00424

- 0.00579 lb as /A

EC 25 /IC 25 : 0.00208 lb as /A 95% C.I.: 0.00163

- 0.00258 lb as /A

EC 05 /IC 05 : 0.000595 lb as /A 95% C.I.: 0.000154

- 0.000925 lb as /A

NOE C: 0.00083 lb as /A

Slope: N/A 95% C.I.: N/A

D. STUDY DEFICIENCIES:

1. The physico

- chemical properties of the test material were not reported

.

E. REVIEWER ’ S COMMENTS:

The reviewer and study author results are in general agreement. Based on the study authors results, t he

most sensitive monocot species was wheat based on dry weight, with NOEC and I R 50 values of 0.0067 and

0.019 lb as /A, respectively

. The most sensitive dicot species was oilseed rape based on dry weight , with

NOEC and I R 50 valu es of 0.00083 and 0.0055 lb as /A, respectively

. The r eviewer found t he most sensitive

monocot species was sorghum based on dry weight

, which is different from the study author’s findings

because the rev iewers based the most sensitive species on the IC 25 a nd the study author determined the mo st

sensitive species from the I R 50 . The NO EC and I C 25 values for sorghum, based on dry weight, were 0.0033

and 0.00613 lb as /A, respectively. The reviewer agreed with the study author, finding the most sensitive

dicot s pecies was oilseed rape based on dry weight, with NO EC and I C 25 values of 0.00 083 and 0.00 208 lb

as /A, respectively

. The reviewer’s results are presented in the Executive Summary and Conclusions

sections of this DER.

Th e in

- life portion of this study was initiated on September 30 , 2003 and completed March 8 , 2004

.

F. CONCLUSIONS:

This study is scientifically sound and is classified as acceptable. The mos t sensitive monocot species was

sorghum based on dry weight, with NOEC and IC 25 values of 0.003 3 and 0.00613 lb as /A, respectively

. The

most sensitive dicot species was oilseed rape based on dry w eight , with NOEC and I C 25 values of 0.00083

and 0.00208 lb as /A, respectively

.

Most sensitive monocot and I C 25 : Sorghum ( dry weight

, 0.0 0613 lb as /A)

. Most sensitive dicot and I C 25 : Oilseed rape ( dry weight , 0.00 208 lb as /A)

.

III. REFERENCES :

1. 

### Finney, D. J. 1971. Probit Analysis, 3 rd 

### Ed. Cambridge University Press.

Cambridge, U.K.

2. 

### F rans, R.E. and Talbert, R.E., Design of Field Experiments and the Measurement and An alysis of

Plant Responses, pp. 15

- 23

, in B. Truelove, ed.

, Research Methods in Weed Science. Southern Weed

Science Society, Auburn University, Alabama, 1977.

### Data Evaluation Record on the Acute Toxicity of Nicosulfuron (DPX

- V9360) 75WG to

Terrestrial Vascular Plants: Vegetative Vigor

PMRA Submission Number {..............} EPA MRID Number 49 169705

Page 20 of 20 3. 

### OECD, OECD Gu ideline for the Testing of Chemicals, Guideline 2 27 , Terrestrial Plant Test:

Vegetative Vigor Test. OECD, July 2006.

4. 

### SAS Institute, Inc. SAS System for Windows, Release 6.12. Cary, NC, SAS Institute, Inc. 1996.