Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa) 

PMRA Submission Number{ ........ } EPA MRID Number43014201 

Data Requirement: 

Test material: DPX-V9360 

Common name Nicosulfuron 

PMRA DATA CODE 

EPA DP Barcode 

OECD Data Point 

EPA MRID 

EPA Guideline 

{ ............ } 

386906 

{ ............ } 

43014201 

850.4500 

Purity: 91.4% 

Chemical name: IUPAC: 2-[[ 4,6-dimethoxypyrimidin-2-yl)-amino-carbonyl]aminosulfonyl]-N ,N-dimethyl-3-

pyridinecarboxamide 

CAS name: Not reported 

CAS No.: 111991-09-04 

Synonyms: Not reported 

Primary Reviewer: Mia Howard 

Staff Scientist, Cambridge Environmental, Inc. 

Secondary Reviewer: Teri S. Myers 

Environmental Scientist, CDM Smith 

Primary Reviewer: Geoffrey Sinclair, Biologist 

EPA/OPP/EFED/ERB 5 

Secondary Reviewer(s): { ...................................... } 

{EPA/OECD/PMRA} 

Reference/Submission No.: {. .................... } 

Company Code 

Active Code 

Use Site Category: 

EPA PC Code 

{ ............ } 

{ ............ } 

{ ............ } 

129008 

[ForPMRA] 

[For PMRA] 

[For PMRA] 

Date Evaluation Completed: {dd-mm-yyyy} 

Stgna . t ure: ~.fir>~ Date: 09/26/12 

Signature: ~ , . · 5 

Date: 08/14/13 ~ 

Date: 8/26/13 

Date: { .. ; ......... } 

CITATION: Hughes, J. 1992. DPX-V9360: Toxicity to Navicula pellicu/osa. An unpublished study performed by 

Malcolm Pirnie, Inc., Tarrytown, NY. Laboratory project B382-153-6. Study sponsored by E.I. du Pont de 

Nemours and Company, Wilmington, DE. Sponsor study number AMR 2320-92. Study completed 03 August 

1992. 

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 aquatic 

nonvascular plants. It is not intended to prescribe conditions to any external party for conducting 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 

Page 1 of 15 
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 1 of 15

Data Requirement: PMRA DATA CODE {............}

EPA DP Barcode 386906

OECD Data Point {............}

EPA MRID 43014201

EPA Guideline 850.4500

Test material: DPX-V9360 Purity: 91.4%

Common name Nicosulfuron

Chemical name: IUPAC: 2-[[4,6-dimethoxypyrimidin-2-yl)-amino-carbonyl]aminosulfonyl]-N,N-dimethyl-3-

pyridinecarboxamide

CAS name: Not reported

CAS No.: 111991-09-04

Synonyms: Not reported

Primary Reviewer: Mia Howard Signature: 

Staff Scientist, Cambridge Environmental, Inc. Date: 09/26/12

Secondary Reviewer: Teri S. Myers Signature: 

Environmental Scientist, CDM Smith Date: 08/14/13 

Primary Reviewer: Geoffrey Sinclair, Biologist Date: 8/26/13

EPA/OPP/EFED/ERB 5

Secondary Reviewer(s): {......................................} Date: {............}

{EPA/OECD/PMRA}

Reference/Submission No.: {.....................}

Company Code {............} [For PMRA]

Active Code {............} [For PMRA] 

Use Site Category: {............} [For PMRA]

EPA PC Code 129008

Date Evaluation Completed: {dd-mm-yyyy}

CITATION: Hughes, J. 1992. DPX-V9360: Toxicity to Navicula pelliculosa. An unpublished study performed by 

Malcolm Pirnie, Inc., Tarrytown, NY. Laboratory project B382-153-6. Study sponsored by E.I. du Pont de 

Nemours and Company, Wilmington, DE. Sponsor study number AMR 2320-92. Study completed 03 August 

1992.

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 aquatic 

nonvascular plants. It is not intended to prescribe conditions to any external party for conducting 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 Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 2 of 15

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.

EXECUTIVE SUMMARY:

In a 120-hour acute toxicity study, cultures of freshwater diatom, Navicula pelliculosa, were exposed to 

nicosulfuron (DPX-V9360) at nominal concentrations of 0 (negative and solvent controls) and 30 μg/L under static 

conditions. Measured concentrations were <5 (<LOD, negative and solvent controls) and 36 μg/L. The NOAEC and 

EC50/IC50 values based on cell density were <36 and >36 μg/L, respectively. The NOAEC and EC50/IC50 values 

based on growth rate were <36 and >36 μg/L, respectively. The NOAEC and EC50/IC50 values based on biomass

were 36 and >36 μg/L respectively. The % growth inhibition of cell density in the treated algal culture as compared 

to the negative control was 19%. 

There were no compound related phytotoxic effects.

This toxicity study is classified as scientifically sound. It does not satisfy the guideline requirement for an acute 

algal (Navicula pelliculosa) toxicity study because it was designed under a prior registration with a lower 

application rate. The application rate under the current registration request is double what was used for this study. 

This study does however provide valuable information and is classified as acceptable.

Results Synopsis

Test Organism: Freshwater diatom, Navicula pelliculosa

Test Type (Flow-through, Static, Static Renewal): Static

Cell density

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: <36 μg/L

Probit Slope: N/A

Growth rate

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: <36 μg/L

Probit Slope: N/A

Biomass

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: 36 μg/L

Probit Slope: N/A

Endpoint(s) Effected: Cell density, growth rate
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 3 of 15

I. MATERIALS AND METHODS

GUIDELINE FOLLOWED: The study followed a protocol which was designed to comply with the US 

EPA’s Pesticide Assessment Guidelines and the Draft Guidelines for NonTarget Plant Testing for Registration of Pesticides in Canada. The 

following deviations from the US EPA OCSPP 850.4500 guideline (2012) 

are noted:

1. Analytical verification was only performed at test initiation. It is recommended that the concentration 

of test substance be verified at minimum at test initiation and termination.

2. The pH and total organic carbon, particulate matter, metal, pesticide, and chlorine contents of the 

dilution water were not reported.

3. This appears to be a limit test based on the estimated environmental concentration (EEC) that would 

result in an application rate of 35 grams a.i. / hectare. The calculated EEC from the study is 24 ug/L. 

The tested concentration of 36 ug/L exceeds this. EPA regulations stipulates however that the limit 

test must be based on the highest application rate on the label rather than the consequent EEC. 

Additionally the application rate used to calculate this limit test is from 1992. Label changes as of 

2011 suggest additional tests per EPA guidance are necessary with the higher application rate 

(calculated as 71 g / hectare.

These deviations do not impact the validity of this study. 

COMPLIANCE: Signed and dated GLP, Quality Assurance and Data Confidentiality 

statements were provided. The study was performed in compliance with the 

FIFRA GLP Standards, 40 CFR Part 160.

A. MATERIALS:

1. Test material DPX-V9360

Description: White solid

Lot No./Batch No. : Lot #31

Purity: 91.4%

Stability of compound 

under test conditions: Reported as stable. Analytical verification was only performed at test 

initiation.

(OECD recommends water solubility, stability in water and light, pKa, Pow, and vapor pressure of test 

compound)

Storage conditions of 

test chemicals: Room temperature

Physicochemical properties of nicosulfuron.

Parameter Values Comments

Water solubility at 20ΕC 9000 mg/L Solubility value is at 

pH= 6.3; the 

temperature of this 
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 4 of 15

Parameter Values Comments

value was not 

specified

Vapor pressure Not reported

UV absorption Not reported

pKa Not reported

Kow Not reported

2. Test organism: 

Name: Freshwater diatom, Navicula pelliculosa

EPA requires a nonvascular species: For tier I testing, only one species, S. capricornutum, to be 

tested; for tier II testing, S. costatum, A. flos-aquae, S. capricorntum, and a freshwater diatom is 

tested. 

OECD suggests the following species are considered suitable: S. capricornutum, S. subspicatus, and 

C. vulgaris. If other species are used, the strain should be reported

Strain: Not reported

Source: In-house cultures originally obtained from the University of Texas Culture 

Collection, Austin, Texas

Age of inoculum: (at test initiation)

Method of cultivation: Maintained in synthetic algal assay procedure nutrient medium with silicon 

(AAP/Si)

B. STUDY DESIGN:

1. Experimental Conditions

a. Range-finding study –N/A.

b. Definitive Study

Table 1: Experimental Parameters

Parameter Details Remarks

Criteria

Acclimation period: Continuously cultured in the 

laboratory
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 5 of 15

Parameter Details Remarks

Criteria

Culturing media and conditions: 

(same as test or not)

Health: (any mortality observed)

Same as test

None reported

EPA recommends two week acclimation 

period.

OECD recommends an amount of algae 

suitable for the inoculation of test 

cultures and incubated under the 

conditions of the test and used when still 

exponentially growing, normally after 

an incubation period of about 3 days. 

When the algal cultures contain 

deformed or abnormal cells, they must 

be discarded.

Test system

Static/static renewal

Renewal rate for static renewal

Static

N/A

EPA expects the test concentrations to 

be renewed every 3 to 4 days (one 

renewal for the 7 day test, 3-4 renewals 

for the 14 day test). 

Incubation facility

Psycrotherm Controlled 

Environmental Incubator Shaker, 

Model G-27

Duration of the test 120 hours

EPA requires: 96-120 hours

OECD: 72 hours 

Test vessel

Material: (glass/stainless steel)

Size:

Fill volume:

Glass

500 mL

100 mL

Erlenmeyer flasks fitted with foam 

stoppers

OECD recommends 250 ml conical 

flasks are suitable when the volume of 

the test solution is 100 ml or use a 

culturing apparatus.

Details of AAP/Si medium
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 6 of 15

Parameter Details Remarks

Criteria

pH at test initiation:

pH at test termination:

Chelator used:

Carbon source:

Salinity (for marine algae):

7.50-7.51

8.16-8.38

Na2EDTAx2H2O

NaHCO3

N/A

OECD recommends the medium pH 

after equilibration with air is ~8 

with less than .001 mmol/l of 

chelator if used.

EPA recommends 20X-AAP and 

chelating agents (e.g. EDTA) in the 

nutrient medium for optimum cell 

growth. Lower concentrations of 

chelating agents (down to one-third 

of the normal concentration 

recommended for AAP medium) may 

be used in the nutrient medium used 

for test solution preparation if it is

suspected that the chelator will 

interact with the test material. 

ASTM reference, E1415-91and D 

3978-80 (reapproved 1987).

If non-standard nutrient medium 

was used, detailed composition 

provided (Yes/No)

A standard medium was used and a 

detailed composition was also 

provided

Dilution water 

source/type:

pH:

salinity (for marine algae):

water pretreatment (if any):

Total Organic Carbon:

particulate matter:

metals:

pesticides:

chlorine:

ASTM Type I reagent grade water

Not reported

N/A

None reported

Not reported

Not reported

Not reported

Not reported

Not reported

EPA pH: Skeletonema costatum= ~8.0 

Others = ~7.5 from beginning to end of 

the test. EPA salinity: 30-35 ppt. EPA is 

against the use of dechlorinated water.

OECD: pH is measured at beginning of 

the test and at 72 hours, it should not 

normally deviate by more than one unit 

during the test.

Indicate how the test material is 

added to the medium (added 

directly or used stock solution)

Used a stock solution prepared in 

DMF

Aeration or agitation Continuous shaking at 100 rpm
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 7 of 15

Parameter Details Remarks

Criteria

Initial cells density 1x104 cells/mL

EPA requires an initial number of 3,000 

- 10,000 cells/mL. For Anabaena flosaquae, cell counts on day 2 are not

required.

OECD recommends that the initial cell 

concentration be approximately 10,000 

cells/ml for S. capricornutum and S. 

subspicatus. When other species are 

used the biomass should be 

comparable.

Number of replicates

Control:

Solvent control:

Treatments:

4

4

4

Fifth control replicates were used 

solely for the measurement of pH at 

72 hours

EPA requires a negative and/or solvent 

control with 3 or more replicates per 

doses. Navicula sp.tests should be 

conducted with four replicate.

OECD preferably three replicates at 

each test concentration and ideally twice 

that number of controls. When a vehicle 

is used to solubilize the test substance, 

additional controls containing the 

vehicle at the highest concentration used 

in the test.

Test concentrations

Nominal: 0 (negative and solvent controls) and 

30 μg/L

Limit test based on maximum 

application rate in Canada of 35 

grams / hectare and “worst case 

conditions of 24 ug/L)
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 8 of 15

Parameter Details Remarks

Criteria

Measured (at initiation): <5 (<LOD, negative and solvent 

controls) and 36 μg/L

EPA requires at least 5 test 

concentrations, with each at least 60% 

of the next higher one. 

OECD recommends at least five 

concentrations arranged in a geometric 

series, with the lowest concentration 

tested should have no observed effect on 

the growth of the algae. The highest 

concentration tested should inhibit 

growth by at least 50% relatively to the 

control and, preferably, stop growth 

completely. 

Solvent (type, percentage, if used) 0.01% N,N-dimethylformamide 

(DMF)

Method and interval of analytical 

verification

The concentration of the test 

substance in the test solution was 

measured at 0 hours using high 

performance liquid chromatography

It is recommended that the 

concentration of test substance be 

verified at minimum at test initiation 

and termination.

Test conditions 

Temperature:

Photoperiod:

Light intensity and quality:

24 ± 2°C

Continuous

4306 ± 646 lux, cool-white 

fluorescent lighting

EPA temperature: Skeletonema: 20ΕC, 

Others: 24-25ΕC; EPA photoperiod: S. 

costatum 14 hr light/ 10 hr dark, 

Others: Continuous; EPA light: 

Anabaena: 2.0 Klux (±15%), Others: 4 -

5 Klux (±15%)

OECD recommended the temperature in 

the range of 21 to25o

C maintained at ± 

2o

C and continuous uniform illumination 

provided at approximately 8000 Lux 

measured with a spherical collector.

Reference chemical (if used)

name:

concentrations:

N/A

Other parameters, if any N/A

2. Observations: 
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 9 of 15

Table 2: Observation parameters

Parameters Details Remarks

Criteria

Parameters measured including the 

growth inhibition/other toxicity 

symptoms

Cell density

Growth rate

Biomass EPA recommends the growth of the algae 

expressed as the cell count per mL, biomass 

per volume, or degree of growth as 

determined by spectrophotometric means.

Measurement technique for cell 

density and other end points

Cell density was measured using 

the Coulter Counter, Model ZM, 

an electronic particle counter. 

The growth rate was calculated 

from cell counts using a 

logarithmic equation. The 

biomass was determined as the 

area under the growth curve.

EPA recommends the measurement 

technique of cell counts or chlorophyll a

OECD recommends the electronic particle 

counter, microscope with counting 

chamber, fluorimeter, spectrophotometer, 

and colorimeter. (note: in order to provide 

useful measurements at low cell 

concentrations when using a 

spectrophotometer, it may be necessary to 

use cuvettes with a light path of at least 4 

cm).

Observation intervals Every 24 hours

EPA and OECD: every 24 hours.

Other observations, if any Cells were microscopically 

examined at test termination for 

morphological abnormalities

Indicate whether there was an 

exponential growth in the control

Yes. After 96and 120 hours, the 

mean cell densities of the 

negative control wee 181x104

cells/mL and 219x104 cells/mL, 

respectively.

EPA requires control cell count at 

termination to be 2X initial count or by a 

factor of at least 16 during the test.

OECD: cell concentration in control 

cultures should have increased by a factor 

of at least 16 within three days.

Were raw data included? Yes

II. RESULTS and DISCUSSION:

A. INHIBITORY EFFECTS:

After 120 hours, the mean cell density of the negative control was 218.8x104 cells/mL, yielding inhibitions 

compared to the negative control of -23 and 19% for the solvent control and 36 μg/L exposure group, 

respectively. There was not a significant difference between the two control groups. The treatment group mean 

was significantly different than that of the pooled control group.

After 120 hours, the mean growth rate of the negative control was 0.539, yielding inhibitions compared to the 
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 10 of 15

negative control of -1 and 4% for the solvent control and 36 μg/L exposure group, respectively. There was not 

a significant difference between the two control groups. The treatment group mean was significantly different 

than that of the pooled control group.

After 120 hours, the mean biomass in the negative control was 3,325,688, yielding inhibitions compared to the 

negative control of -28 and 14% for the solvent control and 36 μg/L exposure group, respectively. There was 

not a significant difference between the two control groups. The treatment group mean was not significantly 

different than that of the pooled control group.

There was not a major change in pH during the study. There were no phytotoxic effects.
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 11 of 15

Table 3: Effect of nicosulfuron on algal growth (freshwater diatom, Navicula pelliculosa)

Treatment 

Nominal (and 

measured) 

concentrations

μg/L

Initial cell

density (x104

cells/mL)

Cell density (x104 cells/mL) at

72 hours 96 hours 120 hours

cell count % inhibition*

Negative control 1 36.7 181.2 218.8 N/A

Solvent control 1 59.6 222.8 268.7 -23

30 (36) 1 25.2 169.8 176.3 19

Reference chemical 

(if used)

N/A

*Calculated by the reviewer relative to the negative control mean

Table 4: Effect of nicosulfuron on algal growth (freshwater diatom, Navicula pelliculosa)

Treatment 

Nominal (and 

measured)

concentrations

μg/L

Growth rate % 

inhibition*

Cumulative 

biomass 

(area under 

the curve)

% 

inhibition*

Negative control 0.539 N/A 3325688 N/A

Solvent control 0.543 -1 4240400 -28

30 (36) 0.517 4 2856565 14

*Calculated by the reviewer relative to the negative control mean

Table 5: Statistical endpoint values.* (calculated by the study author relative to a pooled control group)

Statistical Endpoint Cell density Growth rate Biomass

NOAEC (μg/L) >36 >36 36

EC50 (μg/L) Not calculated

Reference chemical, if used

NOAEC

IC50/EC50

N/A

* Do not use this table, if the study was deemed unacceptable.

B. REPORTED STATISTICS:

The study author statistically analyzed the endpoints for cell density, growth rate, and biomass. The mean 
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 12 of 15

values of the two control groups were compared using a two-tailed t-test. Because there were no statistically 

significant differences, the negative and solvent control groups were combined in a pooled control that was 

compared to the treatment group in all subsequent analyses. The treatment groups were compared to the pooled 

control using one-tailed t-tests. All analyses were performed using SAS Software (SAS Institute, Cary, North 

Carolina).
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 13 of 15

C. VERIFICATION OF STATISTICAL RESULTS:

Statistical Method: The study author statistically analyzed the endpoints for cell density, growth rate, and 

biomass using mean measured exposure concentrations. The means of the two control groups were compared 

using two-tailed t-test. There were no significant differences between the means of the negative and solvent 

control groups. All further calculations were performed relative to the negative control group only. The 

NOAEC values were calculated using by comparing the treatment group to the negative control group via onetailed t-tests. All statistical analyses were performed using Microsoft Excel. The EC50 values were empirically 

estimated.

Cell density

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: 36 μg/L

Probit Slope: N/A

Growth rate

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: 36 μg/L

Probit Slope: N/A

Biomass

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: 36 μg/L

Probit Slope: N/A

D. STUDY DEFICIENCIES:

This appears to be a limit test based on the estimated environmental concentration (EEC) that would result in an 

application rate of 35 grams a.i. / hectare. The calculated EEC from the study is 24 ug/L. The tested concentration 

of 36 ug/L exceeds this. EPA regulations stipulate however that the limit test must be based on the highest 

application rate on the label rather than the consequent EEC. Additionally the application rate used to calculate this 

limit test is from 1992. Label changes as of 2011 suggest additional tests per EPA guidance are necessary with the 

higher application rate (calculated as 71 g / hectare).

E. REVIEWER=S COMMENTS:

The results of the reviewer agreed with those of the study author, even though the study author performed 

analyses relative to a pooled control group and the reviewer performed analyses relative to the negative control 

only. The study author did not directly state NOAEC values, but the reviewer extracted them based on the 

reported results of the t-tests. 

The in-life phase of the definitive test was conducted from 16-21 March 1992.

F. CONCLUSIONS: 

This toxicity study is classified as scientifically sound. It does not satisfy the guideline requirement for an acute 
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 14 of 15

algal (Navicula pelliculosa) toxicity study because it was designed under a prior registration with a lower 

application rate. The application rate under the current registration request is double what was used for this study. 

It is therefore classified as supplemental qualitative.

After 120 hours, the most sensitive endpoint was cell density, which was inhibited by 19% in the treatment 

relative to the negative control. 

Cell density

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: <36 μg/L

Probit Slope: N/A

Growth rate

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: <36 μg/L

Probit Slope: N/A

Biomass

EC05: Not calculable 95% C.I.: N/A

EC50: > 36 μg/L 95% C.I.: Not calculable

NOAEC: 36 μg/L

Probit Slope: N/A

Endpoint(s) Effected: Cell density, growth rate

III. REFERENCES: 

American Society for Testing and Materials (ASTM), 1991, "Standard

Specification for Reagent Water, D 1193-77", Annual Book of ASTM

Standards. Vol 11.01.

Environmental Protection Agency, National Eutrophication Research Program,

1971, Algal Assay Bottle Test

Environmental Protection Agency, PR Notice 86-5, Notice to Producers,

Formulators, Distributors and Registrants, July 29, 1986.

Environmental Protection Agency, Federal Insecticide, Fungicide and

Rodenticide Act (FIFRA); Good Laboratory Practice Standards; Final Rule,

40 CFR Part 160, Federal Register, Vol. 54, No. 158, pp. 34052 - 34074,

August 17, 1989.

Hoist, R.W. and T.C Ellwanger, 1982, Pesticide Assessment Guidelines,

Subdivision J Hazard Evaluation: Nontarget Plants, EPA-540/9-82-020.

Keddy, CJ., C. Boutin, and K. Freemark, 1991, Non-target plant testing and

evaluation for chemical pesticides: Draft guidelines for registration of

pesticides in Canada.
Data Evaluation Report on the Acute Toxicity of Nicosulfuron (DPX-V9360) to Algae 

(Navicula pelliculosa)

PMRA Submission Number {........} EPA MRID Number 43014201

Page 15 of 15

Miller, W.E., J.C Greene and T. Shiroyama, 1978, The Seknastmm

capricornutum Printz Algal -Assay Bottle Test, EPA-600/9-78-018.

Payne, A.G. and R.H. Hali, 1979, "A method for measuring algal toxicity and

application to the safety assessment of new chemical, "Aquatic Toxicology.

ASTM STP 667, L.L. Testing and Materials, pp. 171-180.

Urban, DJ. and NJ. Cook, 1986, Hazard Evaluation Standard Evaluation 

Procedure, Ecological Risk Assessment, EPA 540/9-86-167.

APPENDIX I. OUTPUT OF THE REVIEWER’S STATISTICAL VERIFICATION

T-tests performed in Microsoft Excel:

t-tests

Endpoint Groups compared p-value

cell density controls 0.182915

cell density treatment vs. neg control 0.030644

growth rate controls 0.781678

growth rate treatment vs. neg control 0.047208

biomass controls 0.09706

biomass treatment vs. neg control 0.186677