Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Data Requirement: PMRA Data Code {..........} 

EPA DP Barcode 406344 

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

EPA MRID 48956401 

EPA Guideline OPPTS 850.2300 

Test material: Ethoprop Purity: 96.6% 

Common name: Ethoprop Technical 

Chemical name: IUPAC: O-ethyl S,S-dipropyl phosphorodithioate 

 CAS name: O-ethyl S,S-dipropyl phosphorodithioate 

CAS No.: 13194-48-4 

Synonyms: None 

Primary Reviewer: Rebecca L. Bryan Signature: 

Staff Scientist, CSS-Dynamac Corporation Date: 8/08/13 

Secondary Reviewer: Teri S. Myers Signature: 

Environmental Scientist, CDM Smith Date: 11/06/13

Primary Reviewer: Date: {............} 

{EPA/OECD/PMRA} 

Secondary Reviewer(s): Geoffrey Sinclair Date: 4/3/14 

{EPA/OECD/PMRA} 

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

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

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

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

EPA PC Code 041101

Date Evaluation Completed: 4/3/14 

CITATION: Ross, V. 2012. Ethoprop: Assessment to Determine the Effects on Reproduction in the Mallard Duck. 

Unpublished study performed by Huntingdon Life Sciences, Ltd., Cambridgeshire, England. Laboratory Study No. 

BDG0051. Study sponsored by AMVAC Chemical Corporation, Newport Beach, CA. Study initiated June 20, 2011 

and completed September 25, 2012. 

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 reproductive effects of a pesticide on avian 

species. 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-bycase 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 Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 2 of 18 

EXECUTIVE SUMMARY

The one-generation reproductive toxicity of Ethoprop to 18 pairs per level of 5-month old Mallard ducks (Anas 

platyrhynchos) was assessed over 22 weeks. Ethoprop was administered to the birds in the diet at nominal 

concentrations of 0 (negative control), 1, 3, 10, and 40 mg ai/kg diet. Mean-measured concentrations were 0 

(control), 0.96, 2.8, 9.5, and 37 mg ai/kg diet. 

There were no treatment-related mortality during this test. No apparent treatment-related effects or statisticallysignificant differences for bodyweights, food consumption, reproduction, or egg shell thickness were observed at any 

interval for the 0.96, 2.8, or 9.5 mg ai/kg diet groups. The adult male and female weight gains were significantly 

reduced in the 37 mg ai/kg group (p<0.05 for males and p<0.01 for females) compared to the negative controls at 

study termination. No significant treatment-related differences in hatchling or 14-day survivor bodyweights were 

observed. No significant treatment-related differences in egg shell thickness were observed in the 0.96, 2.8, or 9.5 

mg ai/kg diet groups. At the 37 mg ai/kg-diet level, the eggshell thickness was significantly less than the control 

(p<0.05). No apparent treatment-related effects on reproduction or statistically-significant differences from the 

control were observed at any interval for the 0.96, 2.8, or 9.5 mg ai/kg diet groups. However, at the 37 mg ai/kg-diet 

level, the number of eggs not cracked (as a percentage of total eggs laid) was significantly lower compared to the 

negative control (p<0.051). The NOAEL was 9.5 mg ai/kg diet (mean-measured concentration) based on treatmentrelated effects on adult male and female weight gain, egg shell thickness, and percentage of eggs undamaged of eggs 

laid. 

This study is scientifically sound and meets the guideline requirements for an avian reproduction test with the mallard 

duck. It is thus classified as acceptable. 

Results Synopsis

Test Organism Size/Age (mean Weight): 5 months old; 803 to 1209 g (combined sexes) 

 NOAEL: 9.5 mg ai/kg diet (mean-measured) 

LOAEL: 37 mg ai/kg diet (mean-measured) 

Endpoint(s) affected: Adult male and female weight gains, egg shell thickness, and percentage eggs undamaged 

of eggs laid 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 3 of 18 

I. MATERIALS AND METHODS

GUIDELINE(S) FOLLOWED: U.S. EPA Pesticide Assessment Guidelines, §71-4 and U.S. EPA Ecological 

Effects Test Guidelines OPPTS 850.2300. 

 

No deviations from U.S. EPA OPPTS Guideline No. 850.2300 were observed. 

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

statements were provided. 

A. MATERIALS:

 1. Test Material: Ethoprop 

Description: Clear light yellow liquid 

Lot No./Batch No. : PEA4000032 

Purity: 96.6% 

Stability of compound 

under test conditions: The recoveries of Day 4 diet samples stored at 21°C were 84-106% of Day 0 

measured concentrations. The recoveries of Day 20 diet samples stored at -20°C 

were 91-98% of Day 0 measured concentrations. The test diets were stored 

frozen prior to use. 

Storage conditions of 

test chemicals: Room temperature in the dark. 

 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 4 of 18 

Physicochemical properties of Ethoprop. 

Parameter Values Comments 

Water solubility at 20°C Not reported 

Vapor pressure Not reported 

UV absorption Not reported 

pKa Not reported 

Kow Not reported 

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

2. Test organism: 

Table 1: Test organism 

Parameter Details 

Remarks 

Criteria 

Species (common and scientific names): Mallard duck 

(Anas platyrhynchos) Recommended species include a wild 

waterfowl species, preferably the 

Mallard (Anas platyrhynchos) or an 

upland game species, preferably the 

northern bobwhite (Colinus 

virginianus)

Age at Study Initiation: 5 months old 

Birds approaching their first 

breeding season should be used.

Body Weight: (mean and range) Overall (combined sexes, 

combined treatments) range of 

803 to 1209 g at study initiation. Body weights should be recorded at 

test initiation and at biweekly 

intervals up to week eight or up to 

the onset of egg laying and at 

termination.

Source: Laboratory stock at Huntingdon 

Life Sciences 

Birds were phenotypically 

indistinguishable from wild type. 

All birds should be from the same 

source.
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 5 of 18 

B. STUDY DESIGN:

1. Experimental Conditions 

a. Range-finding study: No range-finding study was reported. 

b. Definitive Study: 

Table 2: Experimental Parameters

Parameter Details 

Remarks 

Criteria 

Acclimation period: 

Conditions (same as test or not): 

Feeding: 

Health (any mortality observed): 

14 days (in-house laboratory 

stock) 

Same as test. 

Basal diet manufactured by 

Special Diet Services (Essex, 

England) was provided daily, ad 

libitum. 

No mortality was observed. 

Healthy birds were used in test. 

Recommended observation period 

includes a 2-3 week health 

observation period prior to selection 

of birds for treatment. Generally, 

birds should be healthy without 

excess mortality. Feeding should be 

ad libitum, and sickness, injuries or 

mortality should be noted. 

Test duration 

Pre-laying exposure: 

Egg-laying exposure: 

Withdrawal period, if used: 

10 weeks 

12 weeks 

N/A 

Recommended pre-laying exposure 

duration:

At least 10 weeks prior to the onset of 

egg-laying. 

Recommended exposure duration 

with egg-laying:

At least 10 weeks. 

Recommended withdrawal period: 

If reduced reproduction is evident, a 

withdrawal period of up to 3 weeks 

should be added to the test phase.
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 6 of 18 

Parameter Details 

Remarks 

Criteria 

Pen (for parental and offspring) 

Size: 

Construction materials: 

Number: 

Not specified 

Galvanized steel pens with plastic 

mesh floors 

18 parental pens/treatment level 

Pens 

Pens should have adequate room and 

be arranged to prevent crosscontamination. 

Materials 

Recommended materials include 

nontoxic material and nonbinding 

material, such as galvanized steel. 

Number 

At least 5 replicate pens should be 

used for Mallards housed in groups 

of 7. For other arrangements, at 

least 12 pens should be used, but 

considerably more may be used if 

birds are kept in pairs. Chicks 

should be housed according to 

parental grouping.

Number of birds per pen (male:female) 2 birds/pen (1 male:1 female) 

One male and one female per pen 

should be used. For quail, one male 

and two females should be used. For 

ducks, two males and five females 

should be used.

Number of pens per group/treatment 

Negative control: 

Solvent control: 

Treated: 

18 pens 

N/A 

18 pens/treatment 

At least 12-16 pens should be used, 

but considerably more if birds are 

kept in pairs. 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 7 of 18 

Parameter Details 

Remarks 

Criteria 

Test concentrations (mg ai/kg diet) 

Nominal: 

Measured: 

0 (control), 1, 3, 10, and 40 mg 

ai/kg diet 

0 (control), 0.96, 2.8, 9.5, and 37 

mg ai/kg diet 

See Appendix II for mean 

measured calculations. 

Recommended test concentrations 

include at least two concentrations 

other than the control; three or more 

will provide a better statistical 

analysis. The highest test 

concentrations should show a 

significant effect or be at or above 

the actual or expected field residue 

level.

Maximum labeled field residue 

anticipated and source of information: Not specified The highest test concentrations 

should show a significant effect or be 

at or above the actual or expected 

field residue level. The source (i.e., 

maximum label rate in lb ai/A and 

ppm), label registration no., label 

date, and site should be cited]

Solvent/vehicle, if used 

Type: 

Amount: 

None 

N/A Recommended solvents include corn 

oil or other appropriate vehicle not 

more than 2% of diet by weight

Was detailed description and nutrient 

analysis of the basal diet provided? 

(Yes/No) 

Yes 

A commercial breeder feed or an 

equivalent that is appropriate for the 

test species is recommended.

Preparation of test diet For each level, test substance was 

dissolved in acetone and mixed 

into a premix basal feed. Test 

diets were stored frozen and 

presented to birds twice weekly 

(every 3 or 4 days). 

A premixed diet containing the test 

substance should be mechanically 

mixed with basal diet. If an 

evaporative vehicle is used, it should 

be completely evaporated prior to 

feeding.

Indicate whether stability and 

homogeneity of test material in diet 

determined (Yes/No) Yes 

See Reviewer’s Comments 

section. 

Were concentrations in diet verified by 

chemical analysis? Yes 

See Reviewer’s Comments 

section. 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 8 of 18 

Parameter Details 

Remarks 

Criteria 

Did chemical analysis confirm that diet 

was stable? 

Homogeneous? 

Yes 

Yes 

See Reviewer’s Comments 

section. 

Feeding and husbandry Feeding and husbandry 

conditions appeared to be 

adequate, given guideline 

recommendations. 

Test conditions (pre-laying) 

Temperature: 

Relative humidity: 

Photoperiod: 

16-19°C 

64-68% 

7 hr light/day through Week 7; 16 

hr light/day thereafter 

Light intensity was 29 to 135 lux. 

Recommended temperature: 

about 21°C (70°F) 

Recommended relative humidity: 

about 55% 

Recommended lighting 

First 8 weeks: 7 h per day. 

Thereafter: 16-17 h per day. 

At least 6 foot-candles are 

recommended at bird level.

Egg Collection and Incubation

Egg collection and storage 

Collection interval: 

Storage temperature: 

Storage humidity: 

Daily 

37.7°C 

54% 

Eggs should be collected daily; 

recommended egg storage 

temperature is approximately 16°C 

(61°F); recommended humidity is 

approximately 65%. 

Recommended collection interval: 

daily

Were eggs candled for cracks prior to 

setting for incubation? Yes 

Eggs should be candled on day 0

Were eggs set weekly? Yes 

When candling was done for fertility? Eggs were candled again on Days 

14 (embryo viability) and 21 

(embryo survival). Quail: approx. day 11 

Ducks: approx. day 14

When the eggs were transferred to the 

hatcher? 

Day 23 

Bobwhite: usually day 21 

Mallard: usually day 23
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 9 of 18 

Parameter Details 

Remarks 

Criteria 

Hatching conditions 

Temperature: 

Humidity: 

Photoperiod: 

36.7°C 

Not reported 

16 hours light/day 

Recommended temperature is 39°C 

(102°F) 

Recommended humidity is 70%

Day the hatched eggs were removed and 

counted Hatched eggs were removed and 

transferred within 24 hours of 

hatching (Days not specified). 

Eggs for bobwhite should be removed 

on day 24; for Mallard on day 27

Were egg shells washed and dried for at 

least 48 hrs before measuring? Yes 

Egg shell thickness 

No. of eggs used: 

Intervals: 

Mode of measurement: 

First egg laid in each replicate on 

the first day of odd numbered 

weeks were collected and 

measured. 

Every other week (Weeks 11, 13, 

15, 17, 19, and 21) 

Four points around the 

circumference of the egg using a 

micrometer to the nearest 0.01 

mm. 

Newly hatched eggs should be 

collected at least once every two 

weeks. Thickness of the shell plus 

membrane should be measured to the 

nearest 0.01 mm with 3 - 4 

measurements per shell.

Reference chemical, if used None used. 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 10 of 18 

 2. Observations: 

Table 3: Observations 

Parameter Details Remarks 

Parameters measured

Parental 

(mortality, body weight, mean feed 

consumption) 

Egg collection and subsequent 

development 

(no. of eggs laid, no. of eggs cracked, 

shell thickness, no. of eggs set, no. of 

viable embryos, no. of live 3 week 

embryos, no. hatched, 

no. of 14-day survivors, average 

weight of 14-d old survivors, mortality, 

gross pathology, others) 

- mortality 

- signs of toxicity 

- body weight 

- feed consumption 

- eggs laid 

- eggs damaged 

- egg shell thickness 

- eggs set 

- viable embryos 

- live 3-week embryos 

- hatchlings 

- hatchling body weight 

- 14-day-old survivors 

- 14-day-old survivor body weight 

Recommended endpoints 

measured include: 

 Eggs laid/pen 

 Eggs cracked/pen 

 Eggs set/pen 

 Viable embryos/pen 

 Live 3-week 

embryos/pen 

 Normal hatchlings/pen

 14-day-old 

survivors/pen 

 14-day-old 

survivors/pen 

 Weights of 14-day-old 

 survivors (mean per 

pen) 

 Egg shell thickness 

 Food consumption 

(mean per pen) 

 Initial and final body 

weight (mean per pen)

Indicate if the test material was 

regurgitated 

No regurgitation reported. 

Observation intervals (for various 

parameters) 

Parental mortality and signs of toxicity 

were recorded daily. Parental body 

weights were recorded on Weeks -2, 0, 2, 

4, 6, 8, and at adult termination (Week 

22). Offspring were weighed when 

removed from the hatcher and at 14 days. 

Parental feed consumption was measured 

weekly. 

Body weights and food 

consumption should be 

measured at least biweekly

Were raw data included? Yes 

II. RESULTS AND DISCUSSION:

A. MORTALITY: 

No mortalities occurred during the study. 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 11 of 18 

B. REPRODUCTIVE AND OTHER ENDPOINTS: 

Abnormal Effects/Behavior: No treatment-related signs of toxicity were observed during the study. The 

incidental observations included cuts/lacerations on feet and lameness in left leg. No treatment-related findings 

were observed based on the gross necropsy results. 

 

Food Consumption: No significant treatment-related differences in food consumption were observed during the 

study. At 40 mg ai/kg, food consumption was reduced compared to the control for first 3 to 6 weeks of 

treatment, but the difference was not statistically significant. The estimated mean dietary intakes for males were 

0.162, 0.457, 1.428, and 5.766 mg/kg/day for the 1, 3, 10, and 40 mg ai/kg groups, respectively. For females, 

the mean dietary intakes were 0.166, 0.473, 1.524, and 6.508 mg/kg/day for the 1, 3, 10, and 40 mg ai/kg groups, 

respectively. 

Body Weight: No treatment-related effects on adult body weight were observed in the 1, 3, or 10 mg ai/kg diet 

groups. At 40 mg ai/kg, the male and female adult body weights were significantly reduced during the pre-egg 

laying period (p<0.001 for males; p<0.01 for females). By test termination, the female body weights were still 

significantly less than the controls (p<0.05). No significant treatment-related differences in hatchling or 14-day 

survivor bodyweights were observed. 

Reproductive Effects: No treatment-related effects on reproductive performance parameters were observed in 

the 1, 3, or 10 mg ai/kg diet groups. At 40 mg ai/kg, the number of eggs laid were significantly lower compared 

to the controls (p<0.05) and the number of cracked eggs (as percentage of total eggs laid) were significantly 

higher compared to the controls (p<0.01). 

No significant treatment-related differences in egg shell thickness were observed in the 1, 3, or 10 mg ai/kg diet 

groups. At 40 mg ai/kg, the eggshell thickness was significantly less than the controls (p<0.001).

Table 4: Reproductive and Other Parameters (nominal concentrations; study author-reported). 

Parameter Control 1 mg ai/kg 3 mg ai/kg 10 mg ai/kg 40 mg ai/kg NOAEC/ 

LOAEC 

No. laying pairs 18 18 18 18 18 40 mg ai/kg 

>40 mg ai/kg 

Eggs laid/pair 794 915 970 903 563 40 mg ai/kg 

>40 mg ai/kg 

Eggs damaged/pair 17 31 30 33 35 40 mg ai/kg 

>40 mg ai/kg 

Eggs set/pair 725 823 867 808 490 40 mg ai/kg 

>40 mg ai/kg 

Viable embryos/pair 597 772 756 715 463 40 mg ai/kg 

>40 mg ai/kg 

Live 3-week 

embryos/pair 

549 734 707 674 415 40 mg ai/kg 

>40 mg ai/kg 

Hatchlings/pair 422 557 568 493 304 40 mg ai/kg 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 12 of 18 

Parameter Control 1 mg ai/kg 3 mg ai/kg 10 mg ai/kg 40 mg ai/kg NOAEC/ 

LOAEC 

>37 mg ai/kg 

14-day old hatchling 

survivors/pair 

414 549 550 479 302 37 mg ai/kg 

>37 mg ai/kg 

Eggs laid/hen 44.1 50.8 53.9 50.2 31.3* 9.5 mg ai/kg 

37 mg ai/kg 

14-day old 

survivors/hen 

23.0 30.5 30.6 26.6 16.8 37 mg ai/kg 

>37 mg ai/kg 

Eggs damaged/eggs laid 

(%) 

2.1 3.4 3.1 3.7 6.2** 9.5 mg ai/kg 

37 mg ai/kg 

Viable embryos/eggs set 

(%) 

82 94 87 88 94 37 mg ai/kg 

>37 mg ai/kg 

Live 3-week 

embryos/viable embryos 

(%) 

92 95 94 94 90 37 mg ai/kg 

>37 mg ai/kg 

Hatchlings/viable 

embryos (%) 

71 72 75 69 66 37 mg ai/kg 

>37 mg ai/kg 

Hatchlings/Live 3-week 

embryos (%) 

77 76 80 73 73 37 mg ai/kg 

>37 mg ai/kg 

14-Day old 

survivors/Eggs laid (%) 

52 60 57 53 54 37 mg ai/kg 

>37 mg ai/kg 

14-day old 

survivors/Hatchlings 

(%) 

98 99 97 97 99 37 mg ai/kg 

>37 mg ai/kg 

Shell thickness (mm) 0.331 0.331 0.328 0.328 0.307*** 9.5 mg ai/kg 

37 mg ai/kg 

Hatchling weight (g) 37.5 37.9 37.7 37.4 36.1 37 mg ai/kg 

>37 mg ai/kg 

14-day old survivors 

weight 

(g) 

287 285 286 292 297 37 mg ai/kg 

>37 mg ai/kg 

Mean food consumption

(g/bird/day) 

171.5 177.2 175.1 166.7 167.4 37 mg ai/kg 

>37 mg ai/kg 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 13 of 18 

Parameter Control 1 mg ai/kg 3 mg ai/kg 10 mg ai/kg 40 mg ai/kg NOAEC/ 

LOAEC 

Weight (g) of parent 

females 

at pre-dose: 

at pre-egg laying b

: 

at end of study b

: 

984.9 

1019.6 

1124.5 

1043.0 

1028.0 

1129.1 

1019.2 

1040.7 

1175.7 

1018.1 

1020.7 

1165.3 

985.7 

971.0** 

103.3* 

9.5 mg ai/kg 

37 mg ai/kg 

Weight (g) of parent 

males 

at pre-dose: 

at pre-egg laying b

: 

at end of study b

: 

1092.3 

1098.2 

1184.8 

1076.1 

1107.0 

1180.9 

1074.5 

1102.0 

1196.6 

1113.9 

1108.5 

1195.4 

1117.4 

1033.3** 

1126.7 

9.5 mg ai/kg 

37 mg ai/kg 

a

 Data obtained from page 12 and Statistical Analysis Tables 1-3 and 5 on pages 285 and 286 of the study report. b The mean adult bodyweights during pre-egg laying (Weeks 2, 4, 6, and 8) and end of study (Week 22) were 

adjusted for pre-dose differences (Weeks -2 and 0). Data on pages 281 and 285 of study report. 

* Statistically different from the control at p<0.05. 

** Statistically different from the control at p<0.01. 

*** Statistically different from the control at p<0.001. 

C. REPORTED STATISTICS: 

The bodyweight, food consumption and reproduction parameters were analyzed for homogeneity of variance 

using Levene’s test. If Levene’s test was significant (p<0.01), a transformation was applied. An analysis of 

variance (ANOVA) or analysis of covariance (ANCOVA) test was performed with treatment as a factor. A 

modified F1 test determined monotonicity (p<0.01). For comparison of treated groups to the control, the 

Williams test was used for analysis if the F1 test was not significant and the Dunnett’s test was used if the F1 

test was significant. Nominal concentrations were used for all analyses. 

D. VERIFICATION OF STATISTICAL RESULTS: 

Statistical Method: Data were tested to determine if they satisfied the assumptions of normality using ShapiroWilks test and homogeneity of variances using Bartlett’s test. Eggshell thickness, food consumption, offspring 

and adult male body weight gain data satisfied both parametric assumptions, while all other endpoints violated at 

least one assumption. No strictly linear monotonic responses were observed for any endpoint; however, 

suggestive dose-dependent negative trends were noted for the median values for eggs not cracked of eggs laid 

and for eggshell thickness. For offspring weights and food consumption, the NOAEC and LOAEC were 

determined using Dunnett’s test. The Wilcoxon/Bonferroni Adj test was used to determine the NOAEC/LOAEC 

values for all other endpoints which were non-parametric data that did not exhibit a monotonic response; the 

Jonckheere-Terpstra test was used to determine the NOAEC/LOAEC for eggs not cracked to eggs laid. Unless 

otherwise indicated, effects were considered statistically significant at p<0.05. These analyses were conducted 

using CETIS version 1.8.7.12 and backend settings approved for use by EFED on 5/29/13. The reviewer relied 

on the mean-measured concentrations to discuss effects in this study. The reviewer-calculated proportional data 

do not match the mean values reported by the study author due to different approaches for estimation and 

modeling of these values; the study author derived proportional means in this study using the generalized mixed 

linear model, while the CETIS program calculated arithmetic ratios to obtain mean proportional data. 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 14 of 18 

NOAEL: 9.5 mg ai/kg diet (mean-measured) 

LOAEL: 37 mg ai/kg diet (mean-measured) 

Endpoint(s) affected: Adult male and female weight gain, egg shell thickness, and eggs not cracked of eggs laid. 

Table 5: Reproductive and Other Parameters (mean-measured concentrations; reviewer-reported). 

Parameter Control 0.96 

mg ai/kg 

2.8 

mg ai/kg 

9.5 

mg ai/kg 

37 

mg ai/kg 

NOAEC/ 

LOAEC 

Eggs laid/pen 44.1 50.8 53.9 50.2 31.3 37 mg ai/kg 

>37 mg ai/kg 

Eggs not cracked/eggs laid 

(%) 

98.1 96.7 97.1 96.5 94.5** 9.5 mg ai/kg 

37 mg ai/kg 

Shell thickness 0.332 0.334 0.329 0.330 0.308* 9.5 mg ai/kg

37 mg ai/kg

Viable embryos/eggs set 

(%) 

87.9 92.7 84.1 87.5 94.8 37 mg ai/kg 

>37 mg ai/kg 

Live embryos/eggs set (%) 82.1 88.6 79.2 81.1 83.5 37 mg ai/kg 

>37 mg ai/kg 

No. of hatchlings/eggs set 

(%) 

59.0 66.2 60.6 58.2 61.5 37 mg ai/kg 

>37 mg ai/kg 

14 Day hatchlings/eggs set 

(%) 

58.1 64.8 56.0 56.4 61.1 37 mg ai/kg 

>37 mg ai/kg 

Live embryos/viable 

embryos (%) 

88.1 95.7 94.4 85.1 88.0 37 mg ai/kg 

>37 mg ai/kg 

Hatchling/live embryos (%) 71.7 70.6 72.5 70.3 72.9 37 mg ai/kg 

>37 mg ai/kg 

14 Day hatchling/no. 

hatched (%) 

98.3 96.9 91.1 97.0 99.3 37 mg ai/kg 

>37 mg ai/kg 

Hatchling weight (g) 37.3 37.8 37.2 37.7 35.4 37 mg ai/kg 

>37 mg ai/kg 

14 Day survivor weight (g) 288 282 282 290 290 37 mg ai/kg 

>37 mg ai/kg 

Mean food consumption 

(g/bird/day) 

173 183 173 167 163 37 mg ai/kg 

>37 mg ai/kg 

Male weight gain (g) 84.4 95.6 100 73.6 17.0* 9.5 mg ai/kg 

>37 mg ai/kg

Female weight gain (g) 119 114 170 150 30.6** 9.5 mg ai/kg 

>37 mg ai/kg
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 15 of 18 

* Statistically different from the control at p<0.05. 

** Statistically different from the control at p<0.01. 

E. STUDY DEFICIENCIES: 

This study is scientifically sound and there were no study deficiencies. 

No deviations from OCSPP guideline 850.2300 were noted. 

F. REVIEWER’S COMMENTS: 

 Results of the reviewer’s statistical verification agreed with that of the study author; however, the study author’s 

analysis additionally detected a significant reduction in eggs laid/hen at the highest treatment level that the 

reviewer’s analysis did not using the Wilcoxon/Bonferroni Adj test. Mean-measured concentrations are reported 

in the Executive Summary and Conclusions sections of the DER. 

 The following validity requirements were met according to OPPTS 850.2300: controls produced an average of 

twenty-three (23) 14-day old survivors per hen during the 10-week production phase (minimum of 14 chicks per 

pen during a 10-week production phase) and adult control mortality was 0%. The validity requirement for egg 

shell thickness was met according to OCSPP 850.2300 guideline requirements (June 2012). The egg shell 

thickness of control eggs was 0.331 mm (minimum requirement of 0.316 mm for Mallard). 

Homogeneity, stability, and concentration verification samples were analyzed for Ethoprop concentrations 

during the definitive study and were included in the study report. The coefficients of variation were 4.94-5.78% 

for the homogeneity samples. The stability samples after 4 days of storage at 21°C were 84-106% of Day 0 

measured concentrations, and stability samples after 20 days of storage at -20°C were 91-98% of Day 0 

measured concentrations. The test concentrations were 89.7-99.5% of nominal for the verification samples. 

Experimental test dates were September 27, 2011 to July 11, 2012. 

G. CONCLUSIONS: 

This study is scientifically sound and meets the guideline requirements for an avian reproduction test with the 

mallard duck. It is thus classified as acceptable. No treatment-related mortalities or signs of toxicity occurred 

during the study. No significant treatment-related differences in food consumption were observed during the 

study. No treatment-related effects on adult body weight were observed in the 0.96, 2.8, or 9.5 mg ai/kg diet 

groups. At the 37 mg ai/kg-diet level, the male and female adult body weights were significantly reduced 

(p<0.05 for males and p<0.01 for females) compared to the negative controls. No significant treatment-related 

differences in hatchling or 14-day survivor bodyweights were observed. No significant treatment-related 

differences in egg shell thickness were observed in the 0.96, 2.8, or 9.5 mg ai/kg diet groups. At the 37 mg 

ai/kg-diet level, the eggshell thickness was significantly less than the control (p<0.05). No apparent treatmentrelated effects on reproduction or statistically-significant differences from the control were observed at any 

interval for the 0.96, 2.8, or 9.5 mg ai/kg diet groups. However, at the 37 mg ai/kg-diet level, the number of 

eggs not cracked (as percentage of total eggs laid) were significantly lower compared to the negative control 

(p<0.01). The NOAEL was 9.5 mg ai/kg diet (mean-measured concentration) based on adult male and female 

weight gain, egg shell thickness, and the proportion of eggs not cracked to eggs laid. Additionally, the study 

author reported a similar result based on the number of eggs laid per hen. 
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 16 of 18 

 NOAEL: 9.5 mg ai/kg diet (mean-measured) 

LOAEL: 37 mg ai/kg diet (mean-measured) 

Endpoint(s) affected: Adult male and female weight gain, egg shell thickness, and percentage eggs undamaged 

of eggs laid.
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 17 of 18 

III. REFERENCES: 

 No references were provided.
Data Evaluation Record on the Reproductive Effects of Ethoprop to Mallard Ducks (Anas 

platyrhynchos)

PMRA Submission Number {......} EPA MRID Number 48956401 

Page 18 of 18 

 APPENDIX I: DETERMINATION OF MEAN MEASURED CONCENTRATIONS: 

Nominal Conc.

(mg ai/kg)

Week of

Formulation

Mean Measured

Conc. (mg ai/kg)

Overall Mean Measured

Conc. (mg ai/kg)

1 1 0.995 

12 0.994 

22 0.897 0.96 

3 1 2.72 

12 2.75 

22 2.8 2.8 

10 1 9.59 

12 9.22 

22 9.55 9.5 

40 1 37.1 

12 37.1 

22 37.9 37 
CETIS Summary Report Report Date: 06 Nov-13 14:47 (p 1 of 8)

Test Code: 041101 48956401 | 09-2440-2282

OCSPP 850.2300 Chronic Avian Reproduction Huntingdon Life Sciences

Batch ID: 12-2507-7919

Start Date: 27 Sep-11

Ending Date:

Test Type: Chronic Avian Repro

Duration: NA

Protocol: OCSPP 850.2300 Chronic Bird Diluent:

Species: Anas Platyrhynchos Brine:

Source: Lab In-House Culture

Analyst:

Age:

Sample ID: 09-3163-6498

Sample Date: 27 Sep-11

Receive Date:

Code: 041101 48956401

Sample Age: NA

Source: AMVAC Chemical Corporation

Station:

Client: CDM Smith

Material: Ethoprop Project:

Comparison Summary

Analysis ID Endpoint NOEL LOEL TOEL PMSD TU Method

06-5704-1770 01 Eggs Laid per Pen 37 >37 NA 30.7% Wilcoxon/Bonferroni Adj Test

06-8805-0672 02 Eggs Not Cracked per E 37 >37 NA 3.11% Wilcoxon/Bonferroni Adj Test

05-9730-0290 02 Eggs Not Cracked per E 9.5 37 18.75 NA Jonckheere-Terpstra Step-Down Test

10-3745-3624 03 Viable Embryos per ES 37 >37 NA 22.0% Wilcoxon/Bonferroni Adj Test

03-2138-3167 04 Live Embryos per ES 37 >37 NA 23.8% Wilcoxon/Bonferroni Adj Test

21-4573-9732 05 Hatchlings per ES 37 >37 NA 33.9% Wilcoxon/Bonferroni Adj Test

03-7919-1788 06 14d Hatchlings per ES 37 >37 NA 35.1% Wilcoxon/Bonferroni Adj Test

00-7660-0907 07 Live Embryos per VE 37 >37 NA 14.6% Wilcoxon/Bonferroni Adj Test

15-7666-3609 08 Hatchlings per LE 37 >37 NA 24.0% Wilcoxon/Bonferroni Adj Test

08-5713-9330 09 14d Hatchlings per NH 37 >37 NA 9.16% Wilcoxon/Bonferroni Adj Test

02-3157-8146 10 Eggshell Thickness 9.5 37 18.75 4.0% Dunnett Multiple Comparison Test

14-2973-8058 10 Eggshell Thickness 9.5 37 18.75 3.23% Williams Multiple Comparison Test

04-8989-0210 11 Hatchling Weight 37 >37 NA 5.73% Dunnett Multiple Comparison Test

00-4569-8537 12 14d Survivor Weight 37 >37 NA 7.22% Dunnett Multiple Comparison Test

12-9932-8250 13 Mean Food Consumptio 37 >37 NA 12.2% Dunnett Multiple Comparison Test

21-3912-0647 14 Weight Gain MALE adult 9.5 37 18.75 78.3% Dunnett Multiple Comparison Test

20-5136-6101 15 Weight Gain FEMALE a 9.5 37 18.75 66.1% Wilcoxon/Bonferroni Adj Test

000-516-187-1 CETISTM v1.8.7.12 Analyst:________ QA:________
CETIS Summary Report Report Date: 06 Nov-13 14:47 (p 2 of 8)

Test Code: 041101 48956401 | 09-2440-2282

OCSPP 850.2300 Chronic Avian Reproduction Huntingdon Life Sciences

Group Control Type Count Mean Min Max Std Err Std Dev CV%

01 Eggs Laid per Pen Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 44.1 33.4 54.8 1 77 5.09 21.6 48.9% 0.0%

0.96 18 50.8 42.9 58.8 9 76 3.78 16 31.5% -15.2%

2.8 18 53.9 45 62.7 2 78 4.2 17.8 33.0% -22.2%

9.5 18 50.2 41.6 58.8 9 83 4.08 17.3 34.5% -13.7%

37 18 31.3 23.4 39.1 1 54 3.72 15.8 50.5% 29.1%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

02 Eggs Not Cracked per EL Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 0.981 0.969 0.993 0.93 1 0.00551 0.0234 2.38% 0.0%

0.96 18 0.967 0.945 0.99 0.84 1 0.0107 0.0454 4.69% 1.38%

2.8 18 0.971 0.954 0.989 0.857 1 0.00826 0.035 3.61% 0.98%

9.5 18 0.965 0.946 0.985 0.853 1 0.00925 0.0392 4.06% 1.6%

37 18 0.945 0.919 0.971 0.833 1 0.0122 0.0518 5.48% 3.69%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

03 Viable Embryos per ES Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 0.879 0.748 1 0.0149 1 0.0622 0.264 30.0% 0.0%

0.96 18 0.927 0.814 1 0.025 1 0.0535 0.227 24.5% -5.5%

2.8 18 0.841 0.672 1 0 1 0.0803 0.341 40.5% 4.25%

9.5 18 0.875 0.736 1 0.0196 1 0.0657 0.279 31.9% 0.45%

37 18 0.948 0.901 0.995 0.696 1 0.0222 0.094 9.91% -7.86%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

04 Live Embryos per ES Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 0.821 0.688 0.954 0 1 0.0629 0.267 32.5% 0.0%

0.96 18 0.886 0.774 0.997 0.025 1 0.0528 0.224 25.3% -7.85%

2.8 18 0.792 0.629 0.954 0 1 0.077 0.327 41.3% 3.6%

9.5 18 0.811 0.667 0.956 0 1 0.0685 0.291 35.8% 1.18%

37 18 0.835 0.768 0.902 0.6 1 0.0316 0.134 16.1% -1.66%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

05 Hatchlings per ES Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 0.59 0.441 0.74 0 1 0.0709 0.301 50.9% 0.0%

0.96 18 0.662 0.54 0.784 0 0.942 0.0577 0.245 36.9% -12.1%

2.8 18 0.606 0.46 0.752 0 0.914 0.0692 0.293 48.4% -2.69%

9.5 18 0.582 0.453 0.71 0 0.851 0.061 0.259 44.5% 1.5%

37 18 0.615 0.513 0.717 0.25 1 0.0484 0.205 33.4% -4.11%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

06 14d Hatchlings per ES Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 0.581 0.432 0.729 0 1 0.0703 0.298 51.4% 0.0%

0.96 18 0.648 0.523 0.773 0 0.942 0.0594 0.252 38.9% -11.6%

2.8 18 0.56 0.403 0.717 0 0.9 0.0744 0.316 56.3% 3.48%

9.5 18 0.564 0.438 0.689 0 0.83 0.0596 0.253 44.9% 2.9%

37 18 0.611 0.508 0.714 0.25 1 0.0488 0.207 33.9% -5.24%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

07 Live Embryos per VE Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 0.881 0.765 0.998 0 1 0.0551 0.234 26.5% 0.0%

0.96 18 0.957 0.929 0.986 0.791 1 0.0134 0.0567 5.92% -8.63%

2.8 17 0.944 0.91 0.977 0.742 1 0.0158 0.0653 6.92% -7.07%

9.5 18 0.851 0.721 0.982 0 1 0.0619 0.263 30.8% 3.38%

37 18 0.88 0.829 0.931 0.647 1 0.0243 0.103 11.7% 0.15%

000-516-187-1 CETISTM v1.8.7.12 Analyst:________ QA:________
CETIS Summary Report Report Date: 06 Nov-13 14:47 (p 3 of 8)

Test Code: 041101 48956401 | 09-2440-2282

OCSPP 850.2300 Chronic Avian Reproduction Huntingdon Life Sciences

Group Control Type Count Mean Min Max Std Err Std Dev CV%

08 Hatchlings per LE Summary

95% LCL 95% UCL %Effect

0 Negative Control 17 0.717 0.591 0.844 0 1 0.0597 0.246 34.3% 0.0%

0.96 18 0.706 0.581 0.831 0 0.961 0.0592 0.251 35.6% 1.57%

2.8 17 0.725 0.597 0.852 0 0.985 0.0601 0.248 34.2% -1.03%

9.5 17 0.703 0.615 0.79 0.357 0.889 0.0414 0.171 24.3% 2.04%

37 18 0.729 0.638 0.821 0.323 1 0.0433 0.184 25.2% -1.67%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

09 14d Hatchlings per NH Summary

95% LCL 95% UCL %Effect

0 Negative Control 16 0.983 0.971 0.994 0.947 1 0.0053 0.0212 2.16% 0.0%

0.96 17 0.969 0.928 1 0.667 1 0.0196 0.0807 8.33% 1.39%

2.8 16 0.911 0.78 1 0 1 0.0614 0.246 27.0% 7.33%

9.5 17 0.97 0.955 0.986 0.913 1 0.00745 0.0307 3.16% 1.25%

37 18 0.993 0.983 1 0.923 1 0.00489 0.0208 2.09% -1.06%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

10 Eggshell Thickness Summary

95% LCL 95% UCL %Effect

0 Negative Control 16 0.332 0.324 0.339 0.29 0.35 0.00353 0.0141 4.25% 0.0%

0.96 15 0.334 0.325 0.344 0.3 0.36 0.0045 0.0174 5.22% -0.78%

2.8 17 0.329 0.32 0.338 0.29 0.357 0.00419 0.0173 5.25% 0.86%

9.5 18 0.33 0.324 0.337 0.295 0.353 0.0032 0.0136 4.11% 0.36%

37 16 0.308 0.296 0.32 0.255 0.35 0.00554 0.0221 7.2% 7.22%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

11 Hatchling Weight Summary

95% LCL 95% UCL %Effect

0 Negative Control 16 37.3 36 38.7 33 43.5 0.635 2.54 6.81% 0.0%

0.96 17 37.8 36.6 39.1 33.7 41.9 0.582 2.4 6.35% -1.33%

2.8 16 37.2 35.5 38.9 28 42.2 0.79 3.16 8.49% 0.34%

9.5 17 37.7 36.3 39.1 33.2 43 0.658 2.71 7.19% -1.08%

37 17 35.4 33.8 37 30.9 44 0.758 3.13 8.83% 5.16%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

12 14d Survivor Weight Summary

95% LCL 95% UCL %Effect

0 Negative Control 16 288 270 306 247 390 8.55 34.2 11.9% 0.0%

0.96 17 282 267 297 238 345 7.19 29.6 10.5% 2.09%

2.8 15 282 272 293 256 323 4.85 18.8 6.65% 2.06%

9.5 17 290 278 301 254 334 5.51 22.7 7.83% -0.59%

37 17 290 276 304 234 342 6.7 27.6 9.54% -0.55%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

13 Mean Food Consumption (Adult) Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 173 158 188 122 224 6.99 29.7 17.1% 0.0%

0.96 18 183 167 199 130 235 7.53 32 17.5% -5.42%

2.8 18 173 156 190 124 229 7.89 33.5 19.4% 0.19%

9.5 18 167 155 180 122 210 5.93 25.2 15.1% 3.5%

37 18 163 151 174 122 206 5.41 23 14.1% 6.06%

Group Control Type Count Mean Min Max Std Err Std Dev CV%

14 Weight Gain MALE adult Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 84.4 61 108 -19 166 11.1 47.1 55.8% 0.0%

0.96 18 95.6 39.1 152 -77 325 26.8 113 119.0% -13.2%

2.8 18 100 49.4 151 -63 304 24 102 102.0% -18.4%

9.5 18 73.6 27 120 -88 257 22.1 93.7 127.0% 12.9%

37 18 17 -23.7 57.7 -136 151 19.3 81.8 481.0% 79.9%

000-516-187-1 CETISTM v1.8.7.12 Analyst:________ QA:________
CETIS Summary Report Report Date: 06 Nov-13 14:47 (p 4 of 8)

Test Code: 041101 48956401 | 09-2440-2282

OCSPP 850.2300 Chronic Avian Reproduction Huntingdon Life Sciences

Group Control Type Count Mean Min Max Std Err Std Dev CV%

15 Weight Gain FEMALE adult Summary

95% LCL 95% UCL %Effect

0 Negative Control 18 119 88.8 148 27 219 14.1 59.7 50.4% 0.0%

0.96 18 114 47.2 181 -332 274 31.7 135 118.0% 3.7%

2.8 18 170 99.2 241 -67 431 33.5 142 83.7% -43.4%

9.5 18 150 110 190 10 307 18.8 79.8 53.2% -26.6%

37 18 30.6 -3.66 64.9 -120 149 16.2 68.9 225.0% 74.2%

000-516-187-1 CETISTM v1.8.7.12 Analyst:________ QA:________
CETIS Summary Report Report Date: 06 Nov-13 14:47 (p 5 of 8)

Test Code: 041101 48956401 | 09-2440-2282

OCSPP 850.2300 Chronic Avian Reproduction Huntingdon Life Sciences

Group Control Type

01 Eggs Laid per Pen Detail

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

0 Negative Control 59 32 68 58 43 35 27 18 63 53

61 57 51 45 77 45 1 1

0.96 50 57 43 28 55 56 57 33 9 43

54 50 55 76 51 55 70 73

2.8 52 73 78 72 52 59 60 44 49 61

70 70 41 56 41 2 54 36

9.5 36 52 63 50 29 52 30 58 56 63

37 50 51 83 9 53 75 56

37 5 40 18 12 18 36 54 45 47 51

26 34 1 41 21 40 30 44

Group Control Type

02 Eggs Not Cracked per EL Detail

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

0 Negative Control 1 1 0.985 0.966 0.93 0.971 1 0.944 0.984 0.981

0.984 1 1 0.978 0.935 1 1 1

0.96 0.84 0.965 1 1 0.982 1 0.982 0.97 1 0.977

1 0.96 0.927 1 0.98 0.873 1 0.959

2.8 0.981 0.986 0.974 1 0.981 0.983 0.983 0.932 0.98 0.967

0.857 0.971 1 0.982 0.927 1 0.981 1

9.5 1 0.962 1 1 0.966 0.981 0.933 0.966 1 1

0.919 0.98 0.941 0.988 1 0.925 0.853 0.964

37 1 0.95 0.889 0.917 1 1 0.944 0.956 0.894 0.922

1 0.971 1 0.976 0.952 0.85 0.833 0.955

Group Control Type

03 Viable Embryos per ES Detail

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

0 Negative Control 0.945 0.968 0.984 1 0.914 0.939 1 1 0.351 1

0.818 1 1 0.907 0.0149 0.976 1 1

0.96 0.974 0.98 0.025 1 1 0.962 1 1 0.889 1

1 0.977 0.935 1 0.978 1 0.984 0.985

2.8 0.957 0.955 0.986 1 0.313 1 1 0.974 1 0.963

1 1 0.027 1 0.972 1 1 0

9.5 1 0.957 0.983 0.979 0.222 0.958 0.962 0.962 0.0196 0.949

0.844 1 1 0.974 1 0.978 1 0.961

37 1 0.714 1 1 0.882 1 0.958 1 1 0.952

1 0.967 1 0.947 0.944 1 0.696 1

Group Control Type

04 Live Embryos per ES Detail

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

0 Negative Control 0.855 0.903 0.984 0.904 0.914 0.909 0.923 1 0.333 0.958

0.618 0.943 0.979 0.651 0 0.905 1 1

0.96 0.897 0.98 0.025 1 0.961 0.962 0.981 0.969 0.889 1

0.904 0.909 0.739 0.986 0.978 0.978 0.922 0.862

2.8 0.87 0.924 0.929 0.97 0.292 1 0.964 0.897 0.933 0.815

0.982 0.742 0.027 0.98 0.944 1 0.98 0

9.5 0.97 0.83 0.966 0.957 0.0741 0.938 0.846 0.962 0 0.864

0.781 0.956 1 0.895 0.75 0.933 0.983 0.902

37 0.667 0.6 0.846 0.818 0.824 0.909 0.917 0.775 0.976 0.81

1 0.933 1 0.868 0.611 0.939 0.609 0.925

000-516-187-1 CETISTM v1.8.7.12 Analyst:________ QA:________
CETIS Summary Report Report Date: 06 Nov-13 14:47 (p 6 of 8)

Test Code: 041101 48956401 | 09-2440-2282

OCSPP 850.2300 Chronic Avian Reproduction Huntingdon Life Sciences

Group Control Type

05 Hatchlings per ES Detail

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

0 Negative Control 0.436 0.71 0.952 0.865 0.686 0.545 0.769 0.6 0.263 0.875

0.473 0.717 0.813 0.256 0 0.667 0 1

0.96 0.846 0.469 0 0.926 0.373 0.692 0.942 0.813 0.333 0.711

0.654 0.636 0.522 0.704 0.891 0.87 0.797 0.738

2.8 0.587 0.879 0.914 0.879 0.25 0.891 0.891 0.692 0.778 0.63

0.618 0.468 0 0.82 0.361 0.5 0.755 0

9.5 0.697 0.532 0.707 0.851 0.037 0.771 0.615 0.846 0 0.407

0.688 0.533 0.705 0.789 0.375 0.333 0.797 0.784

37 0.333 0.514 0.462 0.727 0.471 0.606 0.854 0.25 0.805 0.5

0.875 0.733 1 0.579 0.389 0.576 0.565 0.825

Group Control Type

06 14d Hatchlings per ES Detail

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

0 Negative Control 0.418 0.677 0.952 0.846 0.657 0.545 0.769 0.6 0.263 0.875

0.455 0.679 0.813 0.256 0 0.643 0 1

0.96 0.846 0.469 0 0.926 0.373 0.673 0.942 0.813 0.222 0.711

0.635 0.636 0.5 0.704 0.891 0.804 0.781 0.738

2.8 0.587 0.833 0.9 0.864 0.25 0.891 0.891 0.641 0.756 0.593

0.618 0.468 0 0.78 0.361 0 0.653 0

9.5 0.636 0.489 0.655 0.83 0.037 0.771 0.615 0.827 0 0.407

0.656 0.511 0.705 0.776 0.375 0.311 0.78 0.765

37 0.333 0.514 0.462 0.727 0.471 0.606 0.854 0.25 0.805 0.476

0.875 0.733 1 0.579 0.389 0.576 0.522 0.825

Group Control Type

07 Live Embryos per VE Detail

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

0 Negative Control 0.904 0.933 1 0.904 1 0.968 0.923 1 0.95 0.958

0.756 0.943 0.979 0.718 0 0.927 1 1

0.96 0.921 1 1 1 0.961 1 0.981 0.969 1 1

0.904 0.93 0.791 0.986 1 0.978 0.937 0.875

2.8 0.909 0.968 0.942 0.97 0.933 1 0.964 0.921 0.933 0.846

0.982 0.742 1 0.98 0.971 1 0.98

9.5 0.97 0.867 0.982 0.978 0.333 0.978 0.88 1 0 0.911

0.926 0.956 1 0.919 0.75 0.955 0.983 0.939

37 0.667 0.84 0.846 0.818 0.933 0.909 0.957 0.775 0.976 0.85

1 0.966 1 0.917 0.647 0.939 0.875 0.925

Group Control Type

08 Hatchlings per LE Detail

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

0 Negative Control 0.511 0.786 0.968 0.957 0.75 0.6 0.833 0.6 0.789 0.913

0.765 0.76 0.83 0.393 0.737 0 1

0.96 0.943 0.479 0 0.926 0.388 0.72 0.961 0.839 0.375 0.711

0.723 0.7 0.706 0.714 0.911 0.889 0.864 0.857

2.8 0.675 0.951 0.985 0.906 0.857 0.891 0.925 0.771 0.833 0.773

0.63 0.63 0 0.837 0.382 0.5 0.771

9.5 0.719 0.641 0.732 0.889 0.5 0.822 0.727 0.88 0.471

0.88 0.558 0.705 0.882 0.5 0.357 0.81 0.87

37 0.5 0.857 0.545 0.889 0.571 0.667 0.932 0.323 0.825 0.618

0.875 0.786 1 0.667 0.636 0.613 0.929 0.892

000-516-187-1 CETISTM v1.8.7.12 Analyst:________ QA:________
CETIS Summary Report Report Date: 06 Nov-13 14:47 (p 7 of 8)

Test Code: 041101 48956401 | 09-2440-2282

OCSPP 850.2300 Chronic Avian Reproduction Huntingdon Life Sciences

Group Control Type

09 14d Hatchlings per NH Detail

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

0 Negative Control 0.958 0.955 1 0.978 0.958 1 1 1 1 1

0.962 0.947 1 1 0.964 1

0.96 1 1 1 1 0.972 1 1 0.667 1

0.971 1 0.958 1 1 0.925 0.98 1

2.8 1 0.948 0.984 0.983 1 1 1 0.926 0.971 0.941

1 1 0.951 1 0 0.865

9.5 0.913 0.92 0.927 0.975 1 1 1 0.977 1

0.955 0.958 1 0.983 1 0.933 0.979 0.975

37 1 1 1 1 1 1 1 1 1 0.952

1 1 1 1 1 1 0.923 1

Group Control Type

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 Negative Control 0.323 0.35 0.32 0.328 0.34 0.33 0.34 0.32 0.34 0.333

0.34 0.34 0.34 0.29 0.33 0.343

0.96 0.3 0.355 0.327 0.31 0.34 0.33 0.333 0.34

0.36 0.348 0.326 0.344 0.318 0.325 0.358

2.8 0.336 0.32 0.308 0.337 0.353 0.353 0.32 0.325 0.357 0.334

0.31 0.337 0.335 0.32 0.29 0.33 0.325

9.5 0.32 0.34 0.334 0.327 0.34 0.337 0.325 0.32 0.316 0.328

0.345 0.295 0.328 0.332 0.35 0.335 0.324 0.353

37 0.32 0.307 0.305 0.35 0.327 0.3 0.303 0.32 0.302

0.28 0.32 0.315 0.285 0.33 0.255 0.305

Group Control Type

11 Hatchling Weight Detail

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

0 Negative Control 36.8 43.5 35.2 36.3 36.5 39.1 34.3 36.8 37.9 36.5

38.2 38.9 39.7 33 39.7 35

0.96 39.7 38.7 37.5 33.7 33.8 37.8 39.5 34.7 34.5

38.6 40.8 38.6 39.3 39.2 37.3 37.6 41.9

2.8 42.2 34.4 38.2 40.5 35.9 38.2 39.8 37.2 37.6 38.9

38.5 36.1 37.3 37.6 28 35

9.5 33.2 35.8 34.9 38.1 43 39.1 34.9 35.3 40.8

38.2 35.2 41.1 37.1 38.7 37.1 37.8 41.3

37 34 39.3 35.6 34.7 33.5 35 35.3 31.9 36.4 44

30.9 35.4 33.7 32.4 37.4 34 38.5

Group Control Type

12 14d Survivor Weight Detail

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

0 Negative Control 257 305 292 305 252 264 277 247 303 281

313 286 299 260 280 390

0.96 345 296 321 271 270 272 284 238 260

293 300 247 322 256 249 271 302

2.8 270 279 305 323 270 269 296 256 300 274

279 272 297 288 257

9.5 258 296 312 303 334 271 274 289 300

281 254 283 315 302 262 317 277

37 234 299 299 303 290 297 306 317 321 342

292 255 272 245 286 271 298

000-516-187-1 CETISTM v1.8.7.12 Analyst:________ QA:________
CETIS Summary Report Report Date: 06 Nov-13 14:47 (p 8 of 8)

Test Code: 041101 48956401 | 09-2440-2282

OCSPP 850.2300 Chronic Avian Reproduction Huntingdon Life Sciences

Group Control Type

13 Mean Food Consumption (Adult) Detail

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

0 Negative Control 172 182 157 201 126 204 150 170 212 224

144 190 184 122 206 173 145 156

0.96 155 172 197 160 194 217 137 137 233 161

216 235 130 187 207 177 186 186

2.8 198 162 229 185 124 135 178 163 150 173

228 161 131 132 196 152 224 191

9.5 166 210 137 139 122 154 137 151 197 169

181 190 196 168 155 178 159 200

37 122 190 182 206 133 154 145 179 151 181

181 181 140 150 184 146 151 153

Group Control Type

14 Weight Gain MALE adult Detail

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

0 Negative Control 35 98 -19 94 136 41 50 108 121 58

58 72 166 92 165 91 107 47

0.96 293 60 7 325 -77 -66 -25 105 195 10

74 117 8 83 135 232 112 132

2.8 207 55 -63 94 -23 130 304 68 141 24

48 10 118 -3 139 217 277 57

9.5 51 9 140 14 95 48 133 14 -88 47

170 32 -82 60 205 257 30 189

37 -4 50 -79 132 9 83 -136 -2 -13 35

41 61 52 -132 151 95 44 -81

Group Control Type

15 Weight Gain FEMALE adult Detail

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

0 Negative Control 58 96 219 75 28 110 27 78 173 171

162 194 95 95 124 155 67 206

0.96 140 204 -14 49 89 -332 144 173 141 211

179 21 83 211 88 174 219 274

2.8 88 68 -67 311 -18 138 73 -11 197 231

400 221 121 130 337 274 431 134

9.5 63 161 28 10 178 250 100 104 193 213

92 97 307 184 158 159 263 141

37 -120 -69 5 71 -20 -16 149 105 105 57

-5 0 126 28 30 81 -8 32

000-516-187-1 CETISTM v1.8.7.12 Analyst:________ QA:________