## 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 Determin e the Effects on Reproduction in the Mallard Duck. Unpublished study performed by Huntingdon Life Sciences, Lt d., Cambridgeshire, Engla nd. 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 c oncerning the reproductive effects of a pesticide on avian species. It is not intended to prescribe conditions to a ny 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 expect ed to review and to determine for each study, on a case-bycase basis, whether it is scientifically sound and provide s sufficient information to satisfy applicable data requirements. Studies that fail to meet any of the conditi ons 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 administ ered 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, re production, 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 differe nces in hatchling or 14-day survivor bodyweights were observed. No significant treatment-related differences in e gg 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 repr oduction 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 re quirements 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 ga ins, 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 Guid elines, §71-4 and U.S. EPA Ecological Effects Test Guidelines OPPTS 850.2300.

No deviations from U.S. EPA OPPTS Gu ideline 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 concentr ations. 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 andbe 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 a nd lameness in left leg. No treatment-related findings were observed based on the gross necropsy results. Food Consumption: No significant treatment-related diffe rences 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 significan t. 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 signifi cant 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 th ickness were observed in the 1, 3, or 10 mg ai/kg diet groups. At 40 mg ai/kg, the eggshell thickness wa s significantly less than the controls (p<0.001). Table 4: Reproductive and Other Parameters (n ominal 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 Ta bles 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 parame ters 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 cova riance (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 parame tric 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 th e median values for eggs not cracked of eggs laid and for eggshell thickness. For offspring weight s 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 NOAE C/LOAEC for eggs not cracked to eggs laid. Unless otherwise indicated, effects were considered statistica lly significant at p<0.05. These analyses were conducted using CETIS version 1.8.7.12 and b ackend 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 propor tional 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 e ggs 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 th e 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 (minim um 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 re port. The coefficients of variation were 4.94-5.78% for the homogeneity samples. The stability samples afte r 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 guidelin e 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 diffe rences in food consumption were observed during the study. No treatment-related effects on adult body weight we re 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 a nd 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 bodyweight s 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 le ss than the control (p<0.05). No apparent treatmentrelated effects on reproduction or statistically-significan t 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) we re significantly lower compared to the negative control (p<0.01). The NOAEL was 9.5 mg ai/kg diet (mean-measur ed concentration) based on adult male and female weight gain, egg shell thickness, and the proportion of e ggs 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 ga in, 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: Brine: Species: Anas Platyrhynchos 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 Project: Material: Ethoprop

Comparison Summary NOEL LOEL TOEL

Endpoint Analysis ID Method PMSD TU 37 >37 NA 06-5704-1770 Wilcoxon/Bonferroni Adj Test 30.7% 01 Eggs Laid per Pen 37 >37 NA 06-8805-0672 Wilcoxon/Bonferroni Adj Test 3.11% 02 Eggs Not Cracked per E 9.5 37 18.75 05-9730-0290 Jonckheere-Terpstra Step-Down Test NA 02 Eggs Not Cracked per E 37 >37 NA 10-3745-3624 Wilcoxon/Bonferroni Adj Test 22.0% 03 Viable Embryos per ES 37 >37 NA 03-2138-3167 Wilcoxon/Bonferroni Adj Test 23.8% 04 Live Embryos per ES 37 >37 NA 21-4573-9732 Wilcoxon/Bonferroni Adj Test 33.9% 05 Hatchlings per ES 37 >37 NA 03-7919-1788 Wilcoxon/Bonferroni Adj Test 35.1% 06 14d Hatchlings per ES 37 >37 NA 00-7660-0907 Wilcoxon/Bonferroni Adj Test 14.6% 07 Live Embryos per VE 37 >37 NA 15-7666-3609 Wilcoxon/Bonferroni Adj Test 24.0% 08 Hatchlings per LE 37 >37 NA 08-5713-9330 Wilcoxon/Bonferroni Adj Test 9.16% 09 14d Hatchlings per NH 9.5 37 18.75 02-3157-8146 Dunnett Multiple Comparison Test 4.0% 10 Eggshell Thickness 9.5 37 18.75 14-2973-8058 Williams Multiple Comparison Test 3.23% 10 Eggshell Thickness 37 >37 NA 04-8989-0210 Dunnett Multiple Comparison Test 5.73% 11 Hatchling Weight 37 >37 NA 00-4569-8537 Dunnett Multiple Comparison Test 7.22% 12 14d Survivor Weight 37 >37 NA 12-9932-8250 Dunnett Multiple Comparison Test 12.2% 13 Mean Food Consumptio 9.5 37 18.75 21-3912-0647 Dunnett Multiple Comparison Test 78.3% 14 Weight Gain MALE adult 9.5 37 18.75 20-5136-6101 Wilcoxon/Bonferroni Adj Test 66.1% 15 Weight Gain FEMALE a

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

## 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

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 01 Eggs Laid per Pen Summary 95% LCL 95% UCL %Effect 0 Negative Control 44.1 1 77 21.6 18 48.9% 5.09 33.4 54.8 0.0% 0.96 50.8 9 76 16 18 31.5% 3.78 42.9 58.8 -15.2% 2.8 53.9 2 78 17.8 18 33.0% 4.2 45 62.7 -22.2% 9.5 50.2 9 83 17.3 18 34.5% 4.08 41.6 58.8 -13.7% 37 31.3 1 54 15.8 18 50.5% 3.72 23.4 39.1 29.1%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 02 Eggs Not Cracked per EL Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.981 0.93 1 0.0234 18 2.38% 0.00551 0.969 0.993 0.0% 0.96 0.967 0.84 1 0.0454 18 4.69% 0.0107 0.945 0.99 1.38% 2.8 0.971 0.857 1 0.035 18 3.61% 0.00826 0.954 0.989 0.98% 9.5 0.965 0.853 1 0.0392 18 4.06% 0.00925 0.946 0.985 1.6% 37 0.945 0.833 1 0.0518 18 5.48% 0.0122 0.919 0.971 3.69%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 03 Viable Embryos per ES Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.879 0.0149 1 0.264 18 30.0% 0.0622 0.748 1 0.0% 0.96 0.927 0.025 1 0.227 18 24.5% 0.0535 0.814 1 -5.5% 2.8 0.841 0 1 0.341 18 40.5% 0.0803 0.672 1 4.25% 9.5 0.875 0.0196 1 0.279 18 31.9% 0.0657 0.736 1 0.45% 37 0.948 0.696 1 0.094 18 9.91% 0.0222 0.901 0.995 -7.86%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 04 Live Embryos per ES Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.821 0 1 0.267 18 32.5% 0.0629 0.688 0.954 0.0% 0.96 0.886 0.025 1 0.224 18 25.3% 0.0528 0.774 0.997 -7.85% 2.8 0.792 0 1 0.327 18 41.3% 0.077 0.629 0.954 3.6% 9.5 0.811 0 1 0.291 18 35.8% 0.0685 0.667 0.956 1.18% 37 0.835 0.6 1 0.134 18 16.1% 0.0316 0.768 0.902 -1.66%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 05 Hatchlings per ES Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.59 0 1 0.301 18 50.9% 0.0709 0.441 0.74 0.0% 0.96 0.662 0 0.942 0.245 18 36.9% 0.0577 0.54 0.784 -12.1% 2.8 0.606 0 0.914 0.293 18 48.4% 0.0692 0.46 0.752 -2.69% 9.5 0.582 0 0.851 0.259 18 44.5% 0.061 0.453 0.71 1.5% 37 0.615 0.25 1 0.205 18 33.4% 0.0484 0.513 0.717 -4.11%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 06 14d Hatchlings per ES Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.581 0 1 0.298 18 51.4% 0.0703 0.432 0.729 0.0% 0.96 0.648 0 0.942 0.252 18 38.9% 0.0594 0.523 0.773 -11.6% 2.8 0.56 0 0.9 0.316 18 56.3% 0.0744 0.403 0.717 3.48% 9.5 0.564 0 0.83 0.253 18 44.9% 0.0596 0.438 0.689 2.9% 37 0.611 0.25 1 0.207 18 33.9% 0.0488 0.508 0.714 -5.24%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 07 Live Embryos per VE Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.881 0 1 0.234 18 26.5% 0.0551 0.765 0.998 0.0% 0.96 0.957 0.791 1 0.0567 18 5.92% 0.0134 0.929 0.986 -8.63% 2.8 0.944 0.742 1 0.0653 17 6.92% 0.0158 0.91 0.977 -7.07% 9.5 0.851 0 1 0.263 18 30.8% 0.0619 0.721 0.982 3.38% 37 0.88 0.647 1 0.103 18 11.7% 0.0243 0.829 0.931 0.15%

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

## 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

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 08 Hatchlings per LE Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.717 0 1 0.246 17 34.3% 0.0597 0.591 0.844 0.0% 0.96 0.706 0 0.961 0.251 18 35.6% 0.0592 0.581 0.831 1.57% 2.8 0.725 0 0.985 0.248 17 34.2% 0.0601 0.597 0.852 -1.03% 9.5 0.703 0.357 0.889 0.171 17 24.3% 0.0414 0.615 0.79 2.04% 37 0.729 0.323 1 0.184 18 25.2% 0.0433 0.638 0.821 -1.67%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 09 14d Hatchlings per NH Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.983 0.947 1 0.0212 16 2.16% 0.0053 0.971 0.994 0.0% 0.96 0.969 0.667 1 0.0807 17 8.33% 0.0196 0.928 1 1.39% 2.8 0.911 0 1 0.246 16 27.0% 0.0614 0.78 1 7.33% 9.5 0.97 0.913 1 0.0307 17 3.16% 0.00745 0.955 0.986 1.25% 37 0.993 0.923 1 0.0208 18 2.09% 0.00489 0.983 1 -1.06%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 10 Eggshell Thickness Summary 95% LCL 95% UCL %Effect 0 Negative Control 0.332 0.29 0.35 0.0141 16 4.25% 0.00353 0.324 0.339 0.0% 0.96 0.334 0.3 0.36 0.0174 15 5.22% 0.0045 0.325 0.344 -0.78% 2.8 0.329 0.29 0.357 0.0173 17 5.25% 0.00419 0.32 0.338 0.86% 9.5 0.33 0.295 0.353 0.0136 18 4.11% 0.0032 0.324 0.337 0.36% 37 0.308 0.255 0.35 0.0221 16 7.2% 0.00554 0.296 0.32 7.22%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 11 Hatchling Weight Summary 95% LCL 95% UCL %Effect 0 Negative Control 37.3 33 43.5 2.54 16 6.81% 0.635 36 38.7 0.0% 0.96 37.8 33.7 41.9 2.4 17 6.35% 0.582 36.6 39.1 -1.33% 2.8 37.2 28 42.2 3.16 16 8.49% 0.79 35.5 38.9 0.34% 9.5 37.7 33.2 43 2.71 17 7.19% 0.658 36.3 39.1 -1.08% 37 35.4 30.9 44 3.13 17 8.83% 0.758 33.8 37 5.16%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 12 14d Survivor Weight Summary 95% LCL 95% UCL %Effect 0 Negative Control 288 247 390 34.2 16 11.9% 8.55 270 306 0.0% 0.96 282 238 345 29.6 17 10.5% 7.19 267 297 2.09% 2.8 282 256 323 18.8 15 6.65% 4.85 272 293 2.06% 9.5 290 254 334 22.7 17 7.83% 5.51 278 301 -0.59% 37 290 234 342 27.6 17 9.54% 6.7 276 304 -0.55%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 13 Mean Food Consumption (Adult) Summary 95% LCL 95% UCL %Effect 0 Negative Control 173 122 224 29.7 18 17.1% 6.99 158 188 0.0% 0.96 183 130 235 32 18 17.5% 7.53 167 199 -5.42% 2.8 173 124 229 33.5 18 19.4% 7.89 156 190 0.19% 9.5 167 122 210 25.2 18 15.1% 5.93 155 180 3.5% 37 163 122 206 23 18 14.1% 5.41 151 174 6.06%

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 14 Weight Gain MALE adult Summary 95% LCL 95% UCL %Effect 0 Negative Control 84.4 -19 166 47.1 18 55.8% 11.1 61 108 0.0% 0.96 95.6 -77 325 113 18 119.0% 26.8 39.1 152 -13.2% 2.8 100 -63 304 102 18 102.0% 24 49.4 151 -18.4% 9.5 73.6 -88 257 93.7 18 127.0% 22.1 27 120 12.9% 37 17 -136 151 81.8 18 481.0% 19.3 -23.7 57.7 79.9%

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

## 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

Control Type Mean Min Max Std Dev

Count CV% Std Err Group 15 Weight Gain FEMALE adult Summary 95% LCL 95% UCL %Effect 0 Negative Control 119 27 219 59.7 18 50.4% 14.1 88.8 148 0.0% 0.96 114 -332 274 135 18 118.0% 31.7 47.2 181 3.7% 2.8 170 -67 431 142 18 83.7% 33.5 99.2 241 -43.4% 9.5 150 10 307 79.8 18 53.2% 18.8 110 190 -26.6% 37 30.6 -120 149 68.9 18 225.0% 16.2 -3.66 64.9 74.2%

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

## 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

Control Type Group 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

Control Type Group 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

Control Type Group 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

Control Type Group 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

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

## 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

Control Type Group 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

Control Type Group 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

Control Type Group 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

Control Type Group 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

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

## 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

Control Type Group 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

Control Type Group 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

Control Type Group 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

Control Type Group 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

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

## 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

Control Type Group 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

Control Type Group 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

Control Type Group 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

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