Document ID: EPA-HQ-OPP-2006-0239-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-03-28T04:00Z

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

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	LC50 (ppm)	95% C.I. (ppm)	NOAEC (ppm)	Classification1

(MRID)

Freshwater Organisms

Water flea2

(Daphnia magna)	376	323-437	117	Core

(163169)

Formulation

Rainbow Trout2

(Onchorynchus mykiss)	126	117-135	80	Core

(103023)

Formulation

Estuarine/ Marine organisms

Mysid shrimp

(Mysidopsis bahia)	25	19-38	ND	Core

(135647)

Technical

Sheepshead minnow

(Cyprinodon varigetus)	>163	ND	>163	Core 

(135651)

Formulation

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

Species	NOAEC (ppm)	LOAEC

 (ppm)	Endpoints Affected	Classification1

(MRID)

Freshwater Organisms

Water flea

(Daphnia magna)	50	100	Reduced growth,

Total # of offspring	Core

(135642)

Formulation

Estuarine/ Marine organisms

Mysid shrimp

(Mysidopsis bahia)	0.7	1.7	Parental mortality	Core

(135648)

Formulation

Sheepshead minnow2

(Cyprinodon varigetus)	12.2	20.1	Reduced larval survival	Core

(135644)

Formulation

1Data are from studies originally reviewed and classified in 1984, some
of which used formulated product.  2For 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.

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	LC50 (ppm)	95% C.I. (ppm)	NOAEC (ppm)	Classification1

(MRID)

Acute dose

Mallard duck	>5,000	ND	<2,500	Core

(163168)

Rat	F 1499

M 1858	(1302-1749)

(1420-2546)	1219

975	Minimum

(164901)

Mouse	F  745

M  766	(512-1286)

(525-1341)	487

312	Minimum

(164901)

Guinea Pig	F  607	ND	244	Minimum

(164901)

Acute dietary

Bobwhite quail	>20,000	ND	13,333	Core

(103022)

Mallard duck	>20,000	ND	20,000	Core

(163384)

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

ND-Not determined 

Chronic Studies

Species	NOAEC (ppm)	LOAEC

(ppm)	Endpoint Affected	Classification1

(MRID)

Bobwhite quail	51	ND	None	Core

(135640)

Mallard duck	46	ND	None	Core

(135639)

Rat	250	1000	Number of pups born live, number of pups surviving
Acceptable

(144862)

1Data 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 LC50s, based on mean weight.  Mean weight is the average of the
reported weight range for the test animals.

Adjusted LC50 =  Reported LC50 * (Mean weight/standard weight)^0.25

Data From Reported Terrestrial Insect Studies



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	EC25 (lb ai/A)	NOAEC (lb ai/A)	Endpoint

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 esculentum	tomato	D	0.25	0.063	biomass

Glycine max	soybean	D	>0.50	0.5	none affected

	Echniochloa crus-galli	barnyard grass	M	0.31	0.25	biomass

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	EC25 (lb ai/A)	NOAEC (lb ai/A)	Endpoint

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 esculentum	tomato	D	0.37	0.5	survival

Glycine max	soybean	D	0.005	0.16	survival

	>0.50	0.5	none affected

Echniochloa crus-galli	barnyard grass	M

	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

	



  FILENAME  Appendix E Ecological Effects Data  	E-  PAGE  12