**Aquatic Effects Data**

Fomesafen data were originally submitted in the 1980's. As technical
fomesafen is only slightly soluble in water, some aquatic tests were
conducted with the technical formulation. Some results were expressed in
terms of active ingredient (ai), and some were not. The table below is
from the spreadsheet used to convert study results for use in the risk
assessment. Tables on the following page show the data as reported in
the main body of the risk assessment

![](media/image1.wmf)

**Statistical Analysis of Aquatic Guideline Data**

Data reviews for fomesafen studies were conducted prior to
implementation of current format, which includes statistical analysis
output. Submitted data were reanalyzed using TOXANAL. Output is shown
below.

**Rainbow Trout LC50 (MRID 103023)**

Formulation Test, Data presented as ppm a.i.

RESULTS CALCULATED USING THE MOVING AVERAGE METHOD

SPAN G LC50 95 PERCENT CONFIDENCE LIMITS

3 4.538912E-02 122.8529 115.8801

130.5561

RESULTS CALCULATED USING THE PROBIT METHOD

ITERATIONS G H GOODNESS OF FIT PROBABILITY

5 .1107277 1 .4267987

SLOPE = 14.60391

95 PERCENT CONFIDENCE LIMITS = 9.744345 AND 19.46347

LC50 = 126.1463

95 PERCENT CONFIDENCE LIMITS = 116.9657 AND 134.5229

LC10 = 103.2551

95 PERCENT CONFIDENCE LIMITS = 89.33874 AND 112.2619

Observed NOAEC 80 ppm a.i.

Observed LOAEC 104 ppm a.i.

**Daphnia Formulation (MRID 103024)**

Converted to ppm a.i.

Test 1

RESULTS CALCULATED USING THE MOVING AVERAGE METHOD

SPAN G LC50 95 PERCENT CONFIDENCE LIMITS

6 2.396329E-02 377.6351 308.34

457.0631

RESULTS CALCULATED USING THE PROBIT METHOD

ITERATIONS G H GOODNESS OF FIT PROBABILITY

9 9.542178E-02 1 .9692729

SLOPE = 5.607484

95 PERCENT CONFIDENCE LIMITS = 3.875308 AND 7.339659

LC50 = 375.9313

95 PERCENT CONFIDENCE LIMITS = 322.9891 AND 437.334

LC10 = 223.1645

95 PERCENT CONFIDENCE LIMITS = 167.035 AND 266.9592

Observed NOAEC 117 ppm a.i.

Observed LOAEC 227 ppm a.i.

Daphnia Test 2

RESULTS CALCULATED USING THE PROBIT METHOD

ITERATIONS G H GOODNESS OF FIT PROBABILITY

7 4.173839 36.01717 0

A PROBABILITY OF 0 MEANS THAT IT IS LESS THAN 0.001

SINCE THE PROBABILITY IS LESS THAN 0.05, RESULTS CALCULATED

USING THE PROBIT METHOD PROBABLY SHOULD NOT BE USED.

SLOPE = 3.668311

95 PERCENT CONFIDENCE LIMITS =-3.826039 AND 11.16266

LC50 = 514.0042

95 PERCENT CONFIDENCE LIMITS = 0 AND +INFINITY

LC10 = 231.6107

95 PERCENT CONFIDENCE LIMITS = 0 AND +INFINITY

**Mysid Acute LC50 (MRID135647)**

RESULTS CALCULATED USING THE MOVING AVERAGE METHOD

SPAN G LC50 95 PERCENT CONFIDENCE LIMITS

1 .2345372 24.77577 19.11372 38.04456

RESULTS CALCULATED USING THE PROBIT METHOD

ITERATIONS G H GOODNESS OF FIT PROBABILITY

6 1.863364 2.90676 3.325069E-02

SINCE THE PROBABILITY IS LESS THAN 0.05, RESULTS CALCULATED

USING THE PROBIT METHOD PROBABLY SHOULD NOT BE USED.

SLOPE = 2.350842

95 PERCENT CONFIDENCE LIMITS =-.8581767 AND 5.559861

LC50 = 27.19182

95 PERCENT CONFIDENCE LIMITS = 0 AND +INFINITY

LC10 = 7.838018

95 PERCENT CONFIDENCE LIMITS = 0 AND +INFINITY

**Reported Aquatic Effects Data**

+---------------+----------+-------------+-----------+---------------+
| # Species     | ## LC~5  | ## 95%      | **NOAEC   | **Classi      |
|               | 0~ (ppm) |  C.I. (ppm) | (ppm)**   | fication^1^** |
|               |          |             |           |               |
|               |          |             |           | **(MRID)**    |
+---------------+----------+-------------+-----------+---------------+
| ### Freshwa   |          |             |           |               |
| ter Organisms |          |             |           |               |
+---------------+----------+-------------+-----------+---------------+
| Water flea^2^ | 376      | 323-437     | 117       | Core          |
|               |          |             |           |               |
| *(Daphnia     |          |             |           | \(163169\)    |
| magna)*       |          |             |           |               |
|               |          |             |           | Formulation   |
+---------------+----------+-------------+-----------+---------------+
| Rainbow       | 126      | 117-135     | 80        | Core          |
| Trout^2^      |          |             |           |               |
|               |          |             |           | \(103023\)    |
| *             |          |             |           |               |
| (Onchorynchus |          |             |           | Formulation   |
| mykiss)*      |          |             |           |               |
+---------------+----------+-------------+-----------+---------------+
| ### E         |          |             |           |               |
| stuarine/ Mar |          |             |           |               |
| ine organisms |          |             |           |               |
+---------------+----------+-------------+-----------+---------------+
| Mysid shrimp  | 25       | 19-38       | ND        | Core          |
|               |          |             |           |               |
| *(Mysidopsis  |          |             |           | \(135647\)    |
| bahia)*       |          |             |           |               |
|               |          |             |           | Technical     |
+---------------+----------+-------------+-----------+---------------+
| Sheepshead    | \>163    | ND          | \>163     | Core          |
| minnow        |          |             |           |               |
|               |          |             |           | \(135651\)    |
| *(Cyprinodon  |          |             |           |               |
| varigetus)*   |          |             |           | Formulation   |
+---------------+----------+-------------+-----------+---------------+

^1^Data are from studies originally reviewed and classified in 1984,
some of which used formulated product. ^2^For purposes of this risk
assessment, test concentrations were adjusted for percent a.i. if
necessary, and endpoints were re-calculated using TOXANAL software.

+-----------------+------+------+--------------------+---------------+
| # Species       | ##   | ## L | **Endpoints        | **Classi      |
|                 |  NOA | OAEC | Affected**         | fication^1^** |
|                 | EC ( |      |                    |               |
|                 | ppm) | #    |                    | **(MRID)**    |
|                 |      | #  ( |                    |               |
|                 |      | ppm) |                    |               |
+-----------------+------+------+--------------------+---------------+
| ### Fresh       |      |      |                    |               |
| water Organisms |      |      |                    |               |
+-----------------+------+------+--------------------+---------------+
| Water flea      | 50   | 100  | Reduced growth,    | Core          |
|                 |      |      |                    |               |
| *(Daphnia       |      |      | Total \# of        | \(135642\)    |
| magna)*         |      |      | offspring          |               |
|                 |      |      |                    | Formulation   |
+-----------------+------+------+--------------------+---------------+
| #               |      |      |                    |               |
| ## Estuarine/ M |      |      |                    |               |
| arine organisms |      |      |                    |               |
+-----------------+------+------+--------------------+---------------+
| Mysid shrimp    | 0.7  | 1.7  | Parental mortality | Core          |
|                 |      |      |                    |               |
| *(Mysidopsis    |      |      |                    | \(135648\)    |
| bahia)*         |      |      |                    |               |
|                 |      |      |                    | Formulation   |
+-----------------+------+------+--------------------+---------------+
| Sheepshead      | 12.2 | 20.1 | Reduced larval     | Core          |
| minnow^2^       |      |      | survival           |               |
|                 |      |      |                    | \(135644\)    |
| *(Cyprinodon    |      |      |                    |               |
| varigetus)*     |      |      |                    | Formulation   |
+-----------------+------+------+--------------------+---------------+

^1^Data are from studies originally reviewed and classified in 1984,
some of which used formulated product. ^2^For purposes of this risk
assessment, test concentrations were adjusted for percent a.i.

##### **Aquatic Risk Quotient Calculations**

EFED does not currently use an automated program to calculate aquatic
RQs. Shown below is the spreadsheet used in the calculation.

![](media/image2.wmf)

**Statistical Analysis of Terrestrial Guideline Data**

Data reviews for fomesafen studies were conducted prior to
implementation of current format which includes statistical analysis
output. Submitted data were reanalyzed using TOXANAL. Output is shown
below.

# Mallard Acute LD50 (MRID) 163168

Group Dose (ppm) \# Birds #Birds Died

Control 0 10 0

1 2500 10 1

2 5000 10 1

NO METHOD CAN CALCULATE ANY RESULTS IF THE PERCENT

DEAD IS THE SAME AT ALL TESTED CONCENTRATIONS.

**Mallard Dietary LC50 ( MRID 163384)**

Nominal Test concentrations (ppm) 1756, 2634, 3951, 5926, 8889, 13,333;
20,000

No mortalities occurred in test concentrations

LC50\>20,000 ppm

Bobwhite Quail Dietary LC50 (MRID 103022)

Nominal Test concentrations (ppm) 1756, 2634, 3951, 5926, 8889, 13,333;
20,000

One mortality occurred in 20,000 ppm test concentrations

LC50\>20,000 ppm

NOTE TO REVIEWER: THIS DATA SET DOES NOT MEET

THE CRITERIA ESTABLISHED BY THE COMMITTEE ON

METHODS FOR TOXICITY TESTS WITH AQUATIC ORGANISMS

BECAUSE NO PERCENT DEAD IS GREATER THAN 65 PERCENT.

NEITHER THE BINOMIAL TEST NOR THE MOVING AVERAGE METHOD

CAN GIVE ANY RESULTS FOR THIS DATA. EITHER THE HIGHEST CONCENTRATION

KILLED LESS THAN 50 PERCENT OR THE LOWEST KILLED MORE THAN 50.

IF THE PROBIT SLOPE IS NEGATIVE, ENTER DATA AGAIN USING NUMBER

ALIVE INSTEAD OF NUMBER DEAD.

**Female Guinea Pig LC50 Data (MRID 164900)**

CONC. NUMBER NUMBER PERCENT BINOMIAL

EXPOSED DEAD DEAD PROB.(PERCENT)

1950 5 5 100 3.125

975 5 5 100 3.125

487 5 1 20 18.75

244 5 0 0 3.125

THE BINOMIAL TEST SHOWS THAT 0 AND +INFINITY CAN BE

USED AS STATISTICALLY SOUND CONSERVATIVE 95 PERCENT

CONFIDENCE LIMITS, BECAUSE THE ACTUAL CONFIDENCE LEVEL

ASSOCIATED WITH THESE LIMITS IS GREATER THAN 95 PERCENT.

AN APPROXIMATE LC50 FOR THIS SET OF DATA IS 607.0274

WHEN THERE ARE LESS THAN TWO CONCENTRATIONS AT WHICH THE

PERCENT DEAD IS BETWEEN 0 AND 100, NEITHER THE MOVING AVERAGE NOR THE
PROBIT METHOD CAN GIVE ANY STATISTICALLY SOUND RESULTS.

**Reported Terrestrial Guideline Data**

Shown below is terrestrial animal guideline data as reported in the main
body of the risk assessment.

Acute Studies

+---------------+----------+-------------+-----------+---------------+
| # Species     | ## LC~5  | ## 95%      | **NOAEC   | **Classi      |
|               | 0~ (ppm) |  C.I. (ppm) | (ppm)**   | fication^1^** |
|               |          |             |           |               |
|               |          |             |           | **(MRID)**    |
+---------------+----------+-------------+-----------+---------------+
| #             |          |             |           |               |
| ## Acute dose |          |             |           |               |
+---------------+----------+-------------+-----------+---------------+
| Mallard duck  | \>5,000  | ND          | \<2,500   | Core          |
|               |          |             |           |               |
|               |          |             |           | \(163168\)    |
+---------------+----------+-------------+-----------+---------------+
| Rat           | F 1499   | (1302-1749) | 1219      | Minimum       |
|               |          |             |           |               |
|               | M 1858   | (1420-2546) | 975       | \(164901\)    |
+---------------+----------+-------------+-----------+---------------+
| Mouse         | F 745    | (512-1286)  | 487       | Minimum       |
|               |          |             |           |               |
|               | M 766    | (525-1341)  | 312       | \(164901\)    |
+---------------+----------+-------------+-----------+---------------+
| Guinea Pig    | F 607    | ND          | 244       | Minimum       |
|               |          |             |           |               |
|               |          |             |           | \(164901\)    |
+---------------+----------+-------------+-----------+---------------+
| ###           |          |             |           |               |
| Acute dietary |          |             |           |               |
+---------------+----------+-------------+-----------+---------------+
| Bobwhite      | \>20,000 | ND          | 13,333    | Core          |
| quail         |          |             |           |               |
|               |          |             |           | \(103022\)    |
+---------------+----------+-------------+-----------+---------------+
| Mallard duck  | \>20,000 | ND          | 20,000    | Core          |
|               |          |             |           |               |
|               |          |             |           | \(163384\)    |
+---------------+----------+-------------+-----------+---------------+

^1^Data are from studies originally reviewed and classified in 1984.

ND-Not determined

Chronic Studies

+-----------+---------+-------+----------------------+---------------+
| # Species | ## NOAE | ##    | **Endpoint           | **Classi      |
|           | C (ppm) | LOAEC | Affected**           | fication^1^** |
|           |         |       |                      |               |
|           |         | **(p  |                      | **(MRID)**    |
|           |         | pm)** |                      |               |
+-----------+---------+-------+----------------------+---------------+
| Bobwhite  | 51      | ND    | None                 | Core          |
| quail     |         |       |                      |               |
|           |         |       |                      | \(135640\)    |
+-----------+---------+-------+----------------------+---------------+
| Mallard   | 46      | ND    | None                 | Core          |
| duck      |         |       |                      |               |
|           |         |       |                      | \(135639\)    |
+-----------+---------+-------+----------------------+---------------+
| Rat       | 250     | 1000  | Number of pups born  | Acceptable    |
|           |         |       | live, number of pups |               |
|           |         |       | surviving            | \(144862\)    |
+-----------+---------+-------+----------------------+---------------+

^1^Data are from studies originally reviewed and classified in 1984.

ND-Not determined

**Adjustment of Mammalian Endpoints**

TREX calculates mammalian risk quotients based on the weight of a
standard laboratory rat (350 g). There is currently no method within the
spreadsheet to adjust for alternative weights if a different animal is
more sensitive. Shown below is the spreadsheet used to determine
adjusted LC~50~s, based on mean weight. Mean weight is the average of
the reported weight range for the test animals.

Adjusted LC~50~ = Reported LC~50~ \* (Mean weight/standard weight)\^0.25

![](media/image3.wmf)

#### 

#### Data From Reported Terrestrial Insect Studies

![](media/image4.wmf)

#### Terrestrial Plant Data

The existing data package for fomesafen included efficacy data, but not
guideline plant tests. Upon request, the registrant submitted guideline
studies. At the time of the risk assessment, these studies had not yet
been processed through EFED's Data Evaluation Review. Data taken
directly from the submitted study is presented below, and the most
sensitive endpoints were used in the risk assessment. Provisional
classification of the studies is supplemental. Slight modifications in
endpoints due to a different method of statistical analysis are not
expected to affect overall risk conclusions.

  ------------------ ------------- ------- ------------ ----------- -----------
  Fomesafen                                                         
  Guideline Tests                                                   
  (provisional data,                                                
  not yet reviewed                                                  
  (PDB 11/22/05)                                                    

                                           Vegetative               
                                           vigor (MRID              
                                           46673802)                

  Species            Common        Class   EC~25~ (lb   NOAEC (lb   Endpoint
                                           ai/A)        ai/A)       

  *Raphanus sativus* radish        D       0.0016       0.00098     height

  *Lactuca sativa*   lettuce       D       0.0017       NR          biomass

  *Brassica napus*   oilseed rape  D       0.0034       0.002       biomass

  *Beta vulgaris*    sugarbeet     D       0.16         0.063       biomass

  *Lycopersicon      tomato        D       0.25         0.063       biomass
  esculentum*                                                       

  *Glycine max*      soybean       D       \>0.50       0.5         none
                                                                    affected

                                                                    

  *Echniochloa       barnyard      M       0.31         0.25        biomass
  crus-galli*        grass                                          

  *Allium cepa*      onion         M       \>0.50       0.5         none
                                                                    affected

  *Avena sativa*     oat           M       \>0.50       0.5         none
                                                                    affected

  *Zea mays*         field corn    M       \>0.50       0.5         none
                                                                    affected

                                                                    

  *NR- not reported*                                                

                                                                    

  Species            Common        Class   Seedling                 
                                           emergence                
                                           (MRID                    
                                           46673801)                

  *Raphanus sativus* radish        D       EC~25~ (lb   NOAEC (lb   Endpoint
                                           ai/A)        ai/A)       

  *Lactuca sativa*   lettuce       D       0.11         0.13        survival

  *Brassica napus*   oilseed rape  D       0.23         0.25        biomass

  *Beta vulgaris*    sugarbeet     D       0.079        0.13        survival

  *Lycopersicon      tomato        D       0.37         0.5         survival
  esculentum*                                                       

  *Glycine max*      soybean       D       0.005        0.16        survival

                                           \>0.50       0.5         none
                                                                    affected

  *Echniochloa       barnyard      M                                
  crus-galli*        grass                                          

  *Allium cepa*      onion         M       \>0.50       0.5         none
                                                                    affected

  *Avena sativa*     oat           M       0.089        0.13        biomass

  *Zea mays*         field corn    M       \>0.50       0.5         none
                                                                    affected

                                           \>0.50       0.5         none
                                                                    affected

  *NR- not reported*                                                
  ------------------ ------------- ------- ------------ ----------- -----------

![](media/image5.wmf)