2

Itemized below are the specific comments presented by DAS, summarized in Italics and

followed by EFED’s response. 

1. The Problem Formulation states on Page 8, Environmental Fate Characterization

“The 5-OH degradate was also formed in the anaerobic aquatic study, at a maximum of 34% 

AR, as was the additional degradate TAAA (diclosulam triazoloacetic acid), which was 

present at a maximum of 34% AR in the aqueous phase.”

DAS’s Comment:

The 5-OH degradate was formed in the anaerobic aquatic study at a maximum of 41.3% 

AR and TAAA (diclosulam triazoloacetic acid) was formed at a maximum of 41.5% AR in the 

total system (MRID 44192604). This correction does not affect the final assessment but 

should be changed to accurately reflect the behavior of diclosulam in an anaerobic aquatic 

system.

EFED Response: EFED acknowledges that the maximum %AR values for degradates 5-

OH and TAAA formed in the anaerobic aquatic study originally stated in the PF (34% for 

each) were in error. These errors will be corrected in the Preliminary Risk Assessment 

(PRA).

2. The Problem Formulation states on page 10, Transformation Products:

“the additional degradate TPSA (triazolopyrimidine sulfonic acid) was detected at 0.5 and

8.8% in the aquatic and soil photolysis studies,respectively.”

DAS’s Comment:

 “The TPSA degradate was detected at 8.8 and 4.9% in the aquatic and soil photolysis 

studies, respectively. These corrections do not affect the final assessment but should be 

changed to accurately reflect the behavior of diclosulam and its metabolites.”

EFED’s Response: EFED acknowledges that the maximum %AR values for TPSA in 

the aquatic and soil photolysis studies as originally stated in the PF (0.5 and 8.8% 

respectively) were in error. These errors will be corrected in the PRA.

3. The Problem Formulation states on page 10, Transformation Products: “Although not 

reported as detected in any fate studies, 2,6-dichloroaniline is also expected to be formed as 

a consequence of the 5 conversion of diclosulam to TPSA. A positional isomer of 2,6-

dichloroaniline is 3,5-dichloroaniline, which is an identified degradate of other pesticides, 

and as such as been named a residue of concern.”

DAS’s Comment:

“The aniline ring was labeled in the hydrolysis, soil and aqueous photolysis, aerobic soil 

metabolism, and the aerobic and anaerobic aquatic metabolism studies and 2,6-

dichloroaniline was not identified in any of these studies as a metabolite, as was noted by the 

EPA. 2,6-Dichloroaniline was also not seen in the Nature of Residue studies on hen, goat or 

peanut. Given the lack of evidence to support 2,6-dichloroaniline as a metabolite, we do not 

believe that 2,6-dichloroaniline or its positional isomer 3,5-dicholoroaniline should be 
3

considered residues of concern for diclosulam. Furthermore, we urge that EPA not make a 

residue of concern designation based only on the fact that 3,5-dicholoroaniline is a

degradate of other pesticides, as that does not mean it is a degradate for diclosulam.”

EFED’s Response: As also noted by DAS, in its Problem Formulation EFED stated

“Although not reported as detected in any fate studies, 2,6-dichloroaniline is also expected to 

be formed as a consequence of the conversion of diclosulam to TPSA. A positional isomer of 

2,6-dichloroaniline is 3,5-dichloroaniline, which is an identified degradate of other 

pesticides, and as such has been named a residue of concern.” In this statement, the 

reference to dichloroanilines as “residue of concern” pertains specifically to the “other” 

pesticides referred to. At this time, as no dichloroanilines have been identified as major 

degradates of diclosulam, these compounds are not considered to be residues of concern for 

diclosulam. If the statement in question appears in the PRA, its language will be amended to 

make this point more clearly.

4. Page 11, Table 4. Diclosulam and Its Major Environmental Degradates

DAS’s Comment:

After a review of the studies referenced, some errors in Table 4 were noted. DAS 

proposes Table 4 be replaced with the following corrected table.

EFED’s Response: Upon review of the original data, EFED agrees with the registrant’s 

proposed edits, and has modified the degradate information table accordingly (below). The 

updated values reflect the maximum %AR detected in individual samples, rather than the 

maximum %AR averaged over all samples from a given time point. For the anaerobic 

aquatic study (MRID 44192604), EFED found slightly different %AR values for the 5-OH 

and TAAA degradates in the study report than the values the registrant proposed. In Table 4

the values updated based upon the registrant’s suggestions are footnoted. Values updated 

based upon re-examination of the anaerobic aquatic metabolism study report are footnoted 

separately.
4

Table 4. Diclosulam and Its Major Environmental Degradates 

Code Name/ Synonym Chemical Name Chemical Structure Study Type Ref.

(MRID)

Maximum 

%AR (day)A

Final %AR 

(study length)

PARENT

Diclosulam

SMILES:

ClC1=C(C(=CC=C1)Cl)

N[S](=O)(=O)C3=N[N]

2C(=NC(=CC2=N3)F)O

CC

N-(2,6-

dichlorophenyl)-5-

ethoxy-7-

fluoro[l,2,4]triazolo-

[l,5-c] pyrimidinesulfonamide

MAJOR TRANSFORMATION PRODUCTS

5-OH

hydroxy diclosulam

SMILES: 

ClC1=C(C(=CC=C1)Cl)

N([S](=O)(=O)C3=N[N

]2C(=NC(=CC2=N3)F)

OCC)[H]

N-(2,6-

dichlorophenyl)-5-

hydroxy-7-fluoro-

[l,2,4]triazolo[l,5-c]-

pyrimidine-2-

sulfonamide

Hydrolysis 43441043 4.3C (4), pH 9 

only 4.3C (4)

Aqueous 

photolysis 43441044 -- --

Soil 

photolysis 44192603 1.6 (26) 1.5 (30)

Aerobic soil 43441045 

44045201 16.6 (140) 13.2 (182)

Aerobic 

aquatic 44103530 3.0C (32) 3.0C (32)

Anaerobic 

aquatic 44192604

40.1D (252) 

water 

5.0D (70) 

sediment

40.8D (365)

Total

TFDA,B 44630601

44103531

--

9 (8)

--

 n.d. (148)

8-Cl

chlorohydroxy 

diclosulam

SMILES:

ClC1=C(C(=CC=C1)Cl)

N([S](=O)(=O)C3=N[N

]2C(=NC(=C(C2=N3)Cl

)F)O[H])[H]

N-(2,6-

dichlorophenyl)-8-

chloro-7-fluoro5(6H)-

oxo[l,2,4]triazolo[l,5-

c]-

pyrimidine-2-

sulfonamide

Hydrolysis 43441043 -- --

Aqueous 

photolysis 43441044 -- --

Soil 

photolysis 44192603 -- --

Aerobic soil 43441045 

44045201 15 (182) 15 (182)

Aerobic 

aquatic 44103530 -- --

Anaerobic 

aquatic 44192604 -- --
5

Code Name/ Synonym Chemical Name Chemical Structure Study Type Ref.

(MRID)

Maximum 

%AR (day)

A

Final %AR 

(study length)

TFDA,B 44630601

44103531

--

5 (42)

--

 n.d. (148)

TAAA

diclosulam 

triazoloacetic acid or 

XDE-564 triazoloacetic 

acid

SMILES:

ClC1=C(C(=CC=C1)Cl)

N([S](=O)(=O)C2=N[N

](C(=N2)CC(=O)O[H])[

H])[H]

N-(2,6-

dichloropheny1)-3-

[1,2,4]triazoloacetic 

acid-5-sulfonamide

Hydrolysis 43441043 59.8

C (4) 59.8C (4)

Aqueous 

photolysis 43441044 -- --

Soil 

photolysis 44192603 -- --

Aerobic soil 43441045 

44045201 -- --

Aerobic 

aquatic 44103530 2.

4

C (32) 2.

4

C (32)

Anaerobic 

aquatic 44192604

36.8

D (365)

water

4.9

D (365)

sediment

41.5

D (365)

Total

TFDA,B 44630601

44103531

--

5 (61)

--

n.d. (148)

ASTP

aminosulfonyltriaozlopy

rimidine

SMILES:

N([S](=O)(=O)C2=N[N

]1C(=NC(=CC1=N2)F)

OCC)([H])[H]

5-ethoxy-7-

fluoro[l,2,4]triazolo[l, 5-c]pyrimidine-2-

sulfonamide

Hydrolysis 43441043 -- --

Aqueous 

photolysis 43441044 -- --

Soil 

photolysis 44192603 9.7

C (2

0)9.0

C (30)

Aerobic soil 43441045 

44045201 15.8 (56) 8.1 (182)

Aerobic 

aquatic 44103530 -- --

Anaerobic 

aquatic 44192604 -- --

TFDA,B 44630601

44103531

10 (119)

39 (7)

n.d. (364)

4 (150)

TPSA

triazolopyrimidinesulfon

ic acid

SMILES:

[S](=O)(=O)(C2=N[N]1

C(=NC(=CC1=N2)F)O

CC)O[H]

5-ethoxy-7-

fluoro[l,2,4]triazolo[l, 5-c]pyrimidine-2-

sulfonic acid

Hydrolysis 43441043 -- --

Aqueous 

photolysis 43441044 8.8 (30) 8.8 (30)

Soil 

photolysis 44192603 4.9

C (30) 4.9C (30)

Aerobic soil 43441045 

44045201 -- --

Aerobic 

aquatic 44103530 -- --
6

Code Name/ Synonym Chemical Name Chemical Structure Study Type Ref.

(MRID)

Maximum 

%AR (day)A

Final %AR 

(study length)

Anaerobic 

aquatic 44192604 -- --

TFDA,B 44630601

44103531

--

7 (14)

--

n.d. (148)

Imidate

SMILES:

ClC1=C(C(=CC=C1)Cl)

N([S](=O)(=O)C2=N[N

](C(=N[H])OCC)C(=N2

)CC(=O)O[H])[H]

2-(3-(N-(2,6-

dichlorophenyl

)sulfamoyl)-1-

(ethoxy(imino)

methyl)-1H1,2,4-triazol-5-

yl)acetic acid

Hydrolysis 43441043 28.1C (2) 21.6C (4)

Aqueous 

photolysis 43441044 -- --

Soil 

photolysis 44192603 -- --

Aerobic soil 43441045 

44045201 -- --

Aerobic 

aquatic 44103530 -- --

Anaerobic 

aquatic 44192604 -- --

TFDB 44630601

44103531 -- --

CO2 Carbon dioxide Hydrolysis 43441043 -- --

Aqueous 

photolysis 43441044 -- --

Soil 

photolysis 44192603 11.7C (30) 11.7C (30)

Aerobic soil 43441045 

44045201 45.4 (365) 45.4 (365)

Aerobic 

aquatic 44103530 0.7C (32) 0.7C (32)

Anaerobic 

aquatic 44192604 -- --

TFDA,B 44630601

44103531 -- --

A n.d. means “not detected”.

B Terrestrial field study percentages represent the ratio of degradate concentration to the maximum parent concentration, both in the top layer of soil. C Values updated in agreement with registrant’s suggestions. D Values updated based on re-examination of study report.
5. Pages 6-7, Drinking Water Exposure Assessments Maximum EDWCs for diclosulam 

are shown below.

Maximum EDWCs for diclosulam from page 7 of the EFED Problem Formulation

Drinking Water Source 

(Model Used)

Use (rates 

modeled)

Maximum Estimated Drinking Water 

Concentration (EDWC) 

Acute 

(μg/L)

Chronic 

(μg/L)

Cancer 

(μg/L)

Surface water

(SWCC: 

MSsoybeanSTD 

scenario, ground 

application)

0.0315 lb 

a.i./A/yr 4.44 0.874 0.261

Groundwater (PRZMGW)

0.0315 lb 

a.i./A/yr

(soybeans, NC 

Norfolk loamy 

sand soil: 

cotton)

15.8 11.0 11.0

DAS’s Comment:

The memorandum communicating the Diclosulam Drinking Water Assessment for 

Registration Review dated March 19, 2015 was obtained from EPA and reviewed. DAS notes 

that the assessment is described as a screening-level assessment that used the exposure 

models SWCC, version 1.106, PRZM-GW and SCI-GROW, version 2.3 to estimate 

concentrations of diclosulam in drinking water derived from surface water and groundwater 

sources. Although we question the accuracy of these predictions, assuming that they are 

much larger than those that would be measured in actual environmental samples as is typical 

for the output from these screening-level models and scenarios, DAS agrees that the models 

were used appropriately in a conservative, lower tier of risk assessment because the dietary 

risk assessment passed and no exposure refinements were necessary to develop realistic

EDWCs suitable for higher-tier quantitative risk assessment.

EFED’s Response: EFED thanks the registrant for their comment. 

6. The Problem Formulation states on page 8, with regard to the field dissipation study 

(MRID 44103531): The study was found not to meet Subdivision N Guidelines, in part 

because complete data were not provided for soil samples below the 15 cm depth, thus data 

were insufficient to determine the extent of leaching for parent and degradates.

DAS’s Comment:

It is not clear why the study did not meet Subdivision N Guidelines. The data presented in 

Table XXI of the study report clearly show the extent of leaching for parent and all 

degradates with significant formation fractions. DAS requests the DER for this study be 

provided so that we can give a more detailed response, or that more detail is provided on

how EPA determined the guidelines were not met.
Page 8 of 10

EFED’s Response: The DER in question states that “complete tabular data were not 

reported for soil samples below the 0- to 15-cm depth,” and mentions additional reasons why 

the study does not meet guideline requirements. For example, the study was not conducted 

under typical use conditions, the compound was not applied at maximum label rates, and 

storage stability data were inadequate. In response to DAS’ request, OPP will provide a copy 

of this DER to the registrant.

7. The PF states, in the Stressors of Concern section: “ECOSAR (v 1.11) results indicate 

that the 5-OH and 8-Cl degradates may exhibit toxicity to daphnid that is similar to that of 

parent diclosulam.”

DAS’s Comment:

It is generally recognized that ECOSAR toxicity predictions are highly uncertain for 

pesticides and their degradates due to the lack of such examples in the data set used to 

develop the predictive models. Regardless, parent toxicity is low for all animals tested, and 

even if the toxophore remains in the degradates, it is unlikely they will exhibit greater toxicity 

than the parent molecule.

EFED’s Response:

EFED uses ECOSAR, a computer program developed within the regulatory constraints of 

the Toxic Substances Control Act (TSCA) that uses structure-activity relationships, chemical

class-specific regression equations between log KOW and measured toxicity values, and acuteto-chronic ratios2

. As stated in EFED’s Problem Formulation, high levels (up to 51%) of 

residues in the aerobic soil metabolism study were unextracted and uncharacterized, and the 

possibility that some of these could have consisted of parent diclosulam cannot be ruled out. 

Therefore, in accordance with EFED’s guidance for addressing unextracted residues3, EFED 

plans on including unextracted residues together with the parent compound in the ecological 

aquatic exposure modeling unless data are provided which identify the unextracted residues 

or demonstrate that adequate measures were used to try to extract the residues.

Further, as stated in the guidance3 “If additional evidence is not available, the registrant 

has the option of conducting an additional study on the single soil or sediment with high 

levels of unextracted residues, using a range of solvents with different dielectric constants, 

including the solvents used in previously submitted studies for comparison. If the 

information provided for the single soil or sediment indicate that the unextracted residues 

can be considered strongly sorbed, then this information may be inferred to apply to any 

other soils or sediments with high unextracted residues, in most cases. If the additional data 

for the single soil or sediment indicate that unextracted residues cannot be considered 

strongly sorbed, then data may be needed for additional soils or sediments with high 

unextracted residues”.

8. DAS’s Comment:

The DER for MRID 44192605 (mallard duck) appears to have different verified 

statistical results from those reported in the study report for the lower doses of 50, 125, and 

 2 ECOSAR is found at: http://www.epa.gov/oppt/newchems/tools/21ecosar.htm 3 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues
Page 9 of 10

500 ppm tested in phase II of the study for the eggshell thickness endpoint. Table 5 in the 

study report indicates statistically significant differences from the control were found at p < 

0.01 for the 125 and 500 ppm doses, but no significant difference was found for the 50 ppm 

dose using Dunnett’s test. However, in the DER table giving verified statistical results 

(Phase II – Statistically Significant Endpoints), levels at which the effect was observed 

according to Dunnett’s test were 50, 125, and 500 ppm. It is not clear whether this difference 

is due to a recalculation or is simply an error in summarizing the test report findings. DAS 

requests that EFED assess the DER and study report to determine the reason for the 

difference between the findings of the reviewer and study authors. If the original reported 

NOAEC of 50 ppm is verified, DAS further requests that EFED accept the NOAEC, upgrade 

the study classification from supplemental to acceptable, and waive the request for a new 

mallard reproduction study.

EFED’s Response: EFED routinely conducts an independent statistical analysis of data 

submitted to the Agency, and these independently determined results are reported in the Data 

Evaluation Record (DER). In response to the registrant’s comment, EFED examined the 

DER for MRID 44192605 and confirmed that the statistical results were correctly reported 

by the reviewer. EFED’s analysis was conducted using Statistical Analysis Software (SAS) 

and the standard alpha-level (α) of 0.05. As further verification, EFED re-analyzed the data 

for eggshell thickness (Phase II) using recently implemented statistical software (CETIS) and 

again confirmed a significant difference between the negative control and all treatment 

groups, including the 50 ppm dose group using Dunnett’s test (p<0.03) and William’s test 

(p<0.05). The CETIS statistical report is attached to this memo. There is uncertainty 

regarding which alpha-level was used by the registrant to identify statistically significant 

differences, as this was not identified in the statistical methods section of the report, and 

different values were indicated in the text (p<0.01) versus the tables (p<0.05). Ultimately, 

EFED reiterates the need for a new avian reproduction toxicity study with mallard duck since 

a definitive NOAEC was not identified in the original study.

9. DAS’s Comment:

The risk assessment schemes described in the new guidance are intended for products 

that are applied to foliage and those that are applied to soil or as seed treatments. Diclosulam 

is applied only to soil, has been shown not to be systemic (soybean nature of residue study, 

MRID 44103504), and is unable to be transported to pollen and nectar. The previously 

submitted acute contact honey bee study reported an LD50 >25 μg a.i./bee, practically nontoxic (MRID 43441019). A new acute oral honey bee study for a combination product 

(diclosulam + halauxifen-methyl) reported an LD50 >217 μg product/bee, or >124 μg 

diclosulam/bee. This study can be submitted, if requested. Furthermore, please note that 

diclosulam is only sold on peanuts, and on average, is only used on approximately 200,000 

acres of peanuts a year, with the amount of acres treated remaining relatively flat over the 

past 5 years. Based on the limited use pattern, and the small acres, the risk of pollinator 

exposure to diclosulam is negligible. In this particular case, additional data should not be 

required to perform a risk assessment, as bees/pollinators would not be exposed to 

diclosulam based on the fact diclosulam is soil applied to a small acreage of peanuts, is nonsystemic and is deemed practically non-toxic from an acute contact perspective. Due to the 

nature of the molecule, additional data or label mitigation will not have an impact on overall 
Page 10 of 10

pollinator health within the US. In summary, there is no reasonable potential for exposure to 

the pesticide identified and, according to the guidance, no requirement to conduct a risk 

assessment. Even if exposure were possible, it is highly unlikely toxicity would be found in 

additional testing. The recommended studies are not needed, and DAS requests they be 

waived from further consideration.

EFED’s Response: As stated in the Problem Formulation, while an acute contact toxicity 

study on honey bees has been submitted, an acute oral toxicity study on honey bees is 

needed, as well as an acute larval honey bee toxicity study, a chronic adult honey bee toxicity 

study and a chronic larval honey bee toxicity study. Exposure to soil dwelling bees may 

occur as the result of diclosulam use on peanuts. A 2012 census by the USDA National 

Agricultural Statistics Service (Crop Production and Crop Values) reported 1,042,000 

bearing acres of peanuts in the United States. According to a USDA publication on the 

attractiveness of various crops to pollinators4

, peanut crops are attractive under certain 

conditions to honey bees (Apis mellifera), bumble bees (Bombus sp), and solitary bees (e.g., 

Lasioglossum sp., Megachile sp., Anthidium sp., and Nomia sp.) Bumble bees and solitary 

bees commonly nest in the ground or, as with Anthidium sp., use soil (mud) in the 

construction of their nests5

. Other soil-dwelling bees, such as the southeastern blueberry bee 

(Habropoda laboriosa) are prevalent in the southeastern U.S.6 where diclosulam is used. As 

stated in the pollinator guidance7, EFED’s pollinator toxicity data use the honey bee (Apis 

mellifera) as a surrogate for non-Apis bees. Honey bee semi-field test and a study on field 

residues in pollen and nectar as well as field testing for pollinators (with TEP; 850.3040) are 

held in reserve depending on the results of the acute and chronic larval and adult honey bee 

studies. In the absence of data, EFED will be unable to complete a quantitative risk 

assessment for terrestrial invertebrates (specifically, insect pollinators).

Attached:

CETIS Results Output for Avian Reproduction Study

 4 USDA. 2015. Attractiveness of agricultural crops to pollinating bees for the collection of nectar and/or pollen. Available 

on on-line at: http://www.ree.usda.gov/ree/news/Attractiveness_of_Agriculture_crops_to_pollinating_bees_ReportFINAL.pdf. 5 European Food Safety Authority, 2013. EFSA Guidance Document on the risk assessment of plant

protection products on bees (Apis mellifera, Bombus spp. and solitary bees). Appendix D. EFSA Journal

2013; 11(7):3295, 266 pp., doi: 10.2903/j.efsa.2013.3295.

6 http://www.fs.usda.gov/Internet/FSE_DOCUMENTS/stelprdb5306468.pdf 7http://www2.epa.gov/sites/production/files/2014-06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf
Report Date: 02 Nov-15 11:15 (p 1 of 4)

Test Code: 129122 44192605 | 20-8625-1640

CETIS Analytical Report

OCSPP 850.2300 Chronic Avian Reproduction Wildlife International

Analyzed: 02 Nov-15 10:53

Analysis ID: 00-2929-1491 Endpoint: 10 Eggshell Thickness CETIS Version: CETISv1.9.0

Analysis: Parametric-Control vs Treatments Official Results: Yes

Sample ID: 01-6783-6092

Sample Date: 23 Dec-94

Receipt Date:

Code: 44192605

Sample Age: 24h

Source: DowElanco

Station:

Client: EPA OCSPP EFED

Material: Diclosulum Project: Herbicide

Batch ID: 00-4883-7859

Start Date: 24 Dec-94

Ending Date:

Test Type: Chronic Avian Repro

Duration: n/a

Protocol: OCSPP 850.2300 Chronic Bird Diluent:

Species: Anas Platyrhynchos Brine:

Source: Whistling Wings, Inc.

Analyst: M. Clock-Rust

Age:

Comments:

Rerunning eggshell thickness for MRID 44192605 to respond to registrant's comments regarding the determined NOAEC. No NOAEC was found 

in first phase, and so a second phase was initiated. This data is the from the second phase of the study.

44192605

Control vs Control II Test Stat Critical MSD P-Value Decision(α:5%)

Dunnett Multiple Comparison Test

DF P-Type

Negative Control 50* 2.344 2.101 0.019 27 CDF 0.0292 Significant Effect

125* 3.949 2.101 0.019 27 CDF 3.2E-04 Significant Effect

500* 6.955 2.101 0.018 28 CDF 6.3E-07 Significant Effect

Data Transform Alt Hyp NOEL LOEL TOEL TU PMSD

Untransformed C > T < 50 50 n/a 4.66%

ANOVA Table

Source Sum Squares Mean Square DF F Stat P-Value Decision(α:5%)

Between 0.0294919 0.0098306 3 17.19 <1.0E-37 Significant Effect

Error 0.0320263 0.0005719 56

Total 0.0615182 59

Distributional Tests

Attribute Test Test Stat Critical P-Value Decision(α:1%)

Variances Bartlett Equality of Variance Test 1.558 11.34 0.6689 Equal Variances

Distribution Shapiro-Wilk W Normality Test 0.9814 0.9459 0.4909 Normal Distribution

Conc-ppm Code Count Mean 95% LCL 95% UCL Median Min Max Std Err CV% %Effect

10 Eggshell Thickness Summary

0 N 14 0.3944 0.3822 0.4067 0.3925 0.351 0.427 0.005683 5.39% 0.00%

50 15 0.3736 0.3622 0.385 0.37 0.34 0.42 0.005299 5.49% 5.28%

125 15 0.3593 0.3452 0.3735 0.359 0.309 0.401 0.006591 7.10% 8.90%

500 16 0.3336 0.319 0.3481 0.337 0.268 0.372 0.00681 8.17% 15.43%

Conc-ppm Code

10 Eggshell Thickness Detail

Rep 1 Rep 2 Rep 3 Rep 4 Rep 5 Rep 6 Rep 7 Rep 8 Rep 9 Rep 10

0 N 0.427 0.372 0.391 0.409 0.393 0.402 0.389 0.427 0.4 0.372

0.351 0.383 0.414 0.392

50 0.381 0.37 0.364 0.406 0.358 0.42 0.386 0.376 0.34 0.361

0.37 0.381 0.346 0.375 0.37

125 0.395 0.359 0.359 0.357 0.342 0.337 0.384 0.309 0.32 0.364

0.354 0.401 0.357 0.374 0.378

500 0.345 0.334 0.345 0.354 0.317 0.339 0.372 0.345 0.268 0.358

0.329 0.372 0.335 0.313 0.314 0.297

002-350-533-0 CETISTM v1.9.0.18 Analyst:________ QA:________
Report Date: 02 Nov-15 11:15 (p 2 of 4)

Test Code: 129122 44192605 | 20-8625-1640

CETIS Analytical Report

OCSPP 850.2300 Chronic Avian Reproduction Wildlife International

Analyzed: 02 Nov-15 10:53

Analysis ID: 00-2929-1491 Endpoint: 10 Eggshell Thickness CETIS Version: CETISv1.9.0

Analysis: Parametric-Control vs Treatments Official Results: Yes Centered Untransformed

 Rankits

-0.01

-0.02

-0.03

-0.04

-0.05

-0.06

-0.07

0.00

0.01

0.02

0.03

0.04

0.05

-2.5 -2.0 -1.5 -1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5

10 Eggshell Thickness

 Conc-ppm

Reject Null

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

0.40

0.45

0 N 50 125 500

Graphics

002-350-533-0 CETISTM v1.9.0.18 Analyst:________ QA:________
Report Date: 02 Nov-15 11:15 (p 3 of 4)

Test Code: 129122 44192605 | 20-8625-1640

CETIS Analytical Report

OCSPP 850.2300 Chronic Avian Reproduction Wildlife International

Analyzed: 02 Nov-15 11:13

Analysis ID: 20-5233-6485 Endpoint: 10 Eggshell Thickness CETIS Version: CETISv1.9.0

Analysis: Parametric-Control vs Ord.Treatments Official Results: Yes

Sample ID: 01-6783-6092

Sample Date: 23 Dec-94

Receipt Date:

Code: 44192605

Sample Age: 24h

Source: DowElanco

Station:

Client: EPA OCSPP EFED

Material: Diclosulum Project: Herbicide

Batch ID: 00-4883-7859

Start Date: 24 Dec-94

Ending Date:

Test Type: Chronic Avian Repro

Duration: n/a

Protocol: OCSPP 850.2300 Chronic Bird Diluent:

Species: Anas Platyrhynchos Brine:

Source: Whistling Wings, Inc.

Analyst: M. Clock-Rust

Age:

Comments:

Rerunning eggshell thickness for MRID 44192605 to respond to registrant's comments regarding the determined NOAEC. No NOAEC was found 

in first phase, and so a second phase was initiated. This data is the from the second phase of the study.

44192605

Control vs Control II Test Stat Critical MSD P-Value Decision(α:5%)

Williams Multiple Comparison Test

DF P-Type

Negative Control 50* 2.344 1.673 0.015 27 CDF <0.05 Significant Effect

125* 3.949 1.748 0.016 27 CDF <0.05 Significant Effect

500* 6.955 1.772 0.016 28 CDF <0.05 Significant Effect

Data Transform Alt Hyp NOEL LOEL TOEL TU PMSD

Untransformed C > T < 50 50 n/a 3.93%

ANOVA Table

Source Sum Squares Mean Square DF F Stat P-Value Decision(α:5%)

Between 0.0294919 0.0098306 3 17.19 <1.0E-37 Significant Effect

Error 0.0320263 0.0005719 56

Total 0.0615182 59

Distributional Tests

Attribute Test Test Stat Critical P-Value Decision(α:1%)

Variances Bartlett Equality of Variance Test 1.558 11.34 0.6689 Equal Variances

Distribution Shapiro-Wilk W Normality Test 0.9814 0.9459 0.4909 Normal Distribution

Conc-ppm Code Count Mean 95% LCL 95% UCL Median Min Max Std Err CV% %Effect

10 Eggshell Thickness Summary

0 N 14 0.3944 0.3822 0.4067 0.3925 0.351 0.427 0.005683 5.39% 0.00%

50 15 0.3736 0.3622 0.385 0.37 0.34 0.42 0.005299 5.49% 5.28%

125 15 0.3593 0.3452 0.3735 0.359 0.309 0.401 0.006591 7.10% 8.90%

500 16 0.3336 0.319 0.3481 0.337 0.268 0.372 0.00681 8.17% 15.43%

Conc-ppm Code

10 Eggshell Thickness Detail

Rep 1 Rep 2 Rep 3 Rep 4 Rep 5 Rep 6 Rep 7 Rep 8 Rep 9 Rep 10

0 N 0.427 0.372 0.391 0.409 0.393 0.402 0.389 0.427 0.4 0.372

0.351 0.383 0.414 0.392

50 0.381 0.37 0.364 0.406 0.358 0.42 0.386 0.376 0.34 0.361

0.37 0.381 0.346 0.375 0.37

125 0.395 0.359 0.359 0.357 0.342 0.337 0.384 0.309 0.32 0.364

0.354 0.401 0.357 0.374 0.378

500 0.345 0.334 0.345 0.354 0.317 0.339 0.372 0.345 0.268 0.358

0.329 0.372 0.335 0.313 0.314 0.297

002-350-533-0 CETISTM v1.9.0.18 Analyst:________ QA:________
Report Date: 02 Nov-15 11:15 (p 4 of 4)

Test Code: 129122 44192605 | 20-8625-1640

CETIS Analytical Report

OCSPP 850.2300 Chronic Avian Reproduction Wildlife International

Analyzed: 02 Nov-15 11:13

Analysis ID: 20-5233-6485 Endpoint: 10 Eggshell Thickness CETIS Version: CETISv1.9.0

Analysis: Parametric-Control vs Ord.Treatments Official Results: Yes Centered Untransformed

 Rankits

-0.01

-0.02

-0.03

-0.04

-0.05

-0.06

-0.07

0.00

0.01

0.02

0.03

0.04

0.05

-2.5 -2.0 -1.5 -1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5

10 Eggshell Thickness

 Conc-ppm

Reject Null

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

0.40

0.45

0 N 50 125 500

Graphics

002-350-533-0 CETISTM v1.9.0.18 Analyst:________ QA:________