1 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 

Date: October 29, 2014

PC Code: 128008 

MEMORANDUM DP Barcode: D418672 

SUBJECT: Registration Review: Draft Problem Formulation for Environmental Fate, 

Ecological Risk, Endangered Species, and Human Health Drinking Water 

Exposure Assessments for Boscalid 

FROM: Catherine Aubee, Biologist 

 Katrina White, Ph.D., Environmental Toxicologist 

Environmental Risk Branch IV 

Environmental Fate and Effects Division (7507P) 

REVIEWED 

BY: Thomas Steeger, Ph.D., Senior Science Advisor 

 Jim Carleton, Ph.D., Senior Fate Scientist 

Environmental Risk Branch IV 

Environmental Fate and Effects Division (7507P) 

THROUGH: Thomas Steeger, Ph.D., Acting Branch Chief 

Environmental Risk Branch IV 

 Environmental Fate and Effects Division (7507P) 

 

TO: Maria Piansay, Chemical Review Manager 

 Jill Bloom, Team Leader 

 Linda Arrington, Branch Chief 

 Risk Management and Implementation Branch V 

Pesticide Re-Evaluation Division (7508P) 

 

Steeger, Thomas Digitally signed by Steeger, Thomas 

DN: cn=Steeger, Thomas, 

email=steeger.thomas@epa.gov 

Date: 2014.10.30 11:11:54 -04'00'

Steeger, Thomas Digitally signed by Steeger, Thomas 

DN: cn=Steeger, Thomas, 

email=steeger.thomas@epa.gov 

Date: 2014.10.30 11:12:34 -04'00'

Steeger, Thomas Digitally signed by Steeger, Thomas 

DN: cn=Steeger, Thomas, 

email=steeger.thomas@epa.gov 

Date: 2014.10.30 11:13:13 -04'00'

2014.10.30 

11:18:03 -04'00'

Digitally signed by Jim Carleton 

DN: cn=Jim Carleton, o=EPA/OPP, 

ou=EFED/ERBIV, 

email=carleton.jim@epa.gov, c=US 

Date: 2014.10.30 12:16:28 -04'00'
2 

Table of Contents 

1. Executive Summary ................................................................................................................ 2

2. Introduction ............................................................................................................................. 4

3. Use Characterization ............................................................................................................... 5

4. Conclusions from Previous Risk Assessments ....................................................................... 7

a. Ecological Risk Assessment ................................................................................................ 7

b. Drinking Water Exposure Assessments ............................................................................... 8

c. Clean Water Act Programs .................................................................................................. 9

5. Environmental Fate and Transport.......................................................................................... 9

a. Transformation Products .................................................................................................... 14

6. Receptors............................................................................................................................... 18

a. Ecological Incidents ........................................................................................................... 21

7. Exposure Pathways of Concern ............................................................................................ 22

8. Analysis Plan ........................................................................................................................ 22

a. Stressors of Concern .......................................................................................................... 23

b. Measures of Exposure ........................................................................................................ 23

c. Measures of Effect ............................................................................................................. 25

9. Endangered Species Assessments ......................................................................................... 26

10. Endocrine Disruptor Screening Program (EDSP).............................................................. 26

11. Preliminary Identification of Data Gaps ............................................................................ 26

a. Environmental Fate ............................................................................................................ 26

b. Effects ................................................................................................................................ 29

12. References .......................................................................................................................... 36

Appendix A. Summary of registered products containing boscalid ............................................ 40

Appendix B. Submitted Environmental Fate Studies .................................................................. 42

Appendix C. Submitted Ecological Effects Studies ..................................................................... 50

Appendix D. Screening Tool for Inhalation Risk (v. 1.0) ........................................................... 61

Appendix E. Results from Screening Imbibition Program (SIP) .................................................. 63

1. Executive Summary 

The Environmental Fate and Effects Division (EFED) has completed the draft problem 

formulation for the ecological risk, environmental fate, endangered species, and drinking water 

assessments to be conducted as part of the registration review of the fungicide boscalid (PC Code 

128008, CAS Number 188425-85-6). The problem formulation describes the methods to be used 

during the completion of drinking water and ecological risk assessments in support of registration 

review and provides an overview of the environmental fate, ecological effects, and potential risks 

associated with the use of boscalid. It describes uncertainties which may be encountered in the 

risk assessment and identifies additional studies and other information that would be beneficial to 

its conduct. Below is a summary of data needs and uncertainties. 
3 

x The fate database is incomplete based on the environmental fate data requirements outlined in 

the Code of Federal Regulations Title 40 Part 158 (40CFR158) Subpart N1

 and data are needed 

to reduce uncertainty in risk assessments. Additional data on the following fate parameters are 

recommended. Requested fate studies should be conducted using the technical grade active 

ingredient (TGAI). 

x Anaerobic aquatic metabolism data for one sediment (OCSPP2

 Guideline 835.4400)3 to 

reduce uncertainty in whether unextracted residues are an exposure concern; 

x Aerobic soil metabolism data to reduce uncertainty in whether unextracted residues are an 

exposure concern (OCSPP Guideline 835.41004

); and 

x Environmental Chemistry Methods (OCSPP Guideline 850.61005

) for water, sediment, and 

soil6

. An Environmental Chemistry Method for soil is needed with an LOQ of 0.02 μg 

a.i./kg soil or lower, in anticipation of a possible definitive vegetative vigor toxicity test 

result for cabbage of as low as 0.00004 lb a.i./A. 

x The following ecotoxicity studies are recommended, based on the most current ecological data 

requirements (40 CFR Part 158.6307 et seq.) and risk assessment guidance8

: 

x Acute toxicity to the waterflea (Daphnia magna) (OCSPP Guideline 850.1010)9

; 

x Acute toxicity to the waterflea (OCSPP Guideline 850.1010) using typical end-use 

products that contain other active ingredients (representative TEPs containing boscalid + 

pyraclostrobin + lambda-cyhalothrin, boscalid+pyraclostrobin, and boscalid + 

chlorothalonil); 

x Acute toxicity to estuarine/marine mysid shrimp (Americamysis bahia) (OCSPP Guideline 

850.1035); 

x Early life stage toxicity in estuarine/marine fish (OCSPP Guideline 850.1400); 

x Chronic toxicity to estuarine/marine invertebrates (OCSPP Guideline 850.1350); 

 

1

 CFR. 2013. Title 40 (Protection of the Environment), Chapter 1 (Environmental Protection Agency), Subchapter E (Pesticide Programs), Part 

158 (Data Requirements for Pesticides), Subpart N (Environmental Fate) http://www.ecfr.gov/cgi-bin/textidx?c=ecfr&SID=ff5c7fef3645e7cd5abceca0b597bccb&tpl=/ecfrbrowse/Title40/40cfr158_main_02.tpl

2

 The Series 835 Fate Guidelines were completed when the Office of Chemical Safety and Pollution Prevention (OCSPP) was known as the 

Office of Prevention, Pesticides, and Toxic Substances (OPPTS). 

3

 USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.4300 Aerobic Aquatic Metabolism; OPPTS 835.4400 Anaerobic 

Aquatic Metabolism. EPA 712-C-08-018 & E. 712-C-08-019. October 2008. Office of Prevention, Pesticides, and Toxic Substances. United 

States Environmental Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed 

August 6, 2014). 

4

 USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.4100 Aerobic Soil Metabolism; OPPTS 835.4200 Anaerobic Soil 

Metabolism. EPA712-C-08-016 & E. 712-C-08-017. October 2008. Office of Prevention, Pesticides, and Toxic Substances. U.S. Environmental

Protection Agency. Available at http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series835.htm (Accessed August 22, 2014). 5

 USEPA. 2012. Ecological Effects Test Guidelines. OCSPP 850.6100: Environmental Chemistry Methods. EPA 712-C-001. January 2012. 

Office of Chemical Safety and Pollution Prevention. U.S. Environmental Protection Agency. Available at 

http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series850.htm (Accessed August 10, 2014). 

6

 Environmental chemistry methods (ECM) are recommended when there is a potential for a risk concern in an environmental media (USEPA, 

2012b). The limit of quantitation (LOQ) should be low enough to detect concentrations that could result in adverse effects to organisms. 

Currently, there is a risk concern for terrestrial plants and effects were observed for dicotyledonous plants at the lowest application rate tested; 

therefore additional data are being recommended. If new plant data are submitted and the definitive endpoint results in effects at an application 

rate lower than the current LOQ for the ECM for soil, an ECM with a lower LOQ may be needed. However, the current ECM for soil may have a 

low enough LOQ to cover a new definitive terrestrial plant endpoint. Therefore, an ECM for soils may not be necessary at this time. 7

 CFR. 2014. Title 40 (Protection of the Environment), Part 158 (Data Requirements for Pesticides) Subpart G (Ecological Effects) §158.630 

(Terrestrial and aquatic non-target organism data requirements table). http://www.ecfr.gov/cgi-bin/textidx?SID=b89b30110740e33a25b44c51806f0f62&node=40:25.0.1.1.9.7.1.1&rgn=div8 (last accessed 03/26/14). 8

 Requested ecotoxicity studies should be conducted using TGAI, unless otherwise indicated. 

9

 USEPA. 1996. Ecological Effects Test Guidelines OPPTS 850.1010. Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids. EPA 

712-C-96.114. April 1996. 

http://www.epa.gov/opptsmnt/pubs/frs/publications/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines/Drafts/850-1010.pdf (last 

accessed 03/26/14).
4 

x Fish full-life cycle data with freshwater fish (OCSPP Guideline 850.1500; protocol 

submission recommended); 

x Chronic Sediment toxicity data for three species of aquatic invertebrates (protocol 

submission recommended)10; and, 

x Tier II terrestrial plant vegetative vigor data (OCSPP Guideline 850.4150) using TEP. The 

previously submitted study did not yield a definitive endpoint for cabbage. 

Additionally, the initial boscalid registration was accompanied by a data call-in for freshwater 

mollusc toxicity data. These data were not submitted. In response to a subsequent BASF waiver 

request (DP Barcode D312672, 2005), EFED noted the following: 

... mollusk biology differs greatly from other invertebrates, which precludes the use of nonmolluskan toxicity studies for assessing risks to mollusks. Further supporting concerns for 

freshwater mollusks is that review of the toxicity test on eastern oysters indicated that 

effects of boscalid on eastern oysters is likely biologically significant. These results 

suggest that risks to freshwater mollusks are possible for some current and proposed uses 

of boscalid. A study on the toxicity of boscalid to freshwater mollusks would reduce some 

uncertainty in evaluating risks to freshwater mollusks although, in the absence of data on 

freshwater mollusks, risks will be assumed for instances where RQs exceed the LOC using 

the eastern oyster toxicity endpoints for future proposed uses of boscalid. 

In the absence of toxicity data with a freshwater mollusc species, risk conclusions for 

estuarine/marine molluscs will continue to apply to freshwater molluscs. 

2. Introduction 

Boscalid is a carboxamide fungicide11 that degrades slowly in soil (time to 50% decline, DT50, 

ranges from 108 to 578 days) and aquatic systems (DT50 ranges from 385 days to stable). It is 

practically nontoxic to terrestrial vertebrates and the honey bee (Apis mellifera) on an acute 

exposure basis; it is at least moderately toxic to aquatic organisms on an acute exposure basis at 

concentrations approaching its water solubility limit. Chronic exposure to animals may reduce 

growth. Terrestrial plants vary in sensitivity to boscalid exposure, with dicotyledonous (dicot) 

plants generally being most sensitive to growth inhibition; a “no observed adverse effect” level 

(NOAEL) has not been established for this effect in dicot plants. 

In fungal cells, the target mode of action is the inhibition of mitochondrial adenosine triphosphate 

(ATP) production. Specifically, boscalid inhibits the succinate-ubiquinone oxidoreductase system 

in Complex III of the mitochondrial electron transfer chain (Wharton, 2010). This mode of action 

is shared with other pesticide active ingredients, including carboxin (CAS Number 5234-68-4) and 

flutolanil (CAS Number 66332-96-5), and more recently registered compounds such as 

fluxapyroxad (CAS Number 907204-31-3). 

 

10 40 CFR Part 156.630 does not specify the sediment species that are recommended for testing. Testing on all three species (Chironomus dilutus, 

Hyalella azteca, and Leptocheirus plumulosus) is recommended based on differences in the in life histories (infaunal versus epibenthic) and 

differences observed in sensitivities of different species for different chemical classes. A protocol is recommended to be submitted for review 

prior to test initiation. 

11 Group 7 according to the classification system of the Fungicide Resistance Action Committee (Fungicide Resistance Action Committee, 2012).
5 

The use on ornamentals reflects both the maximum single and annual application rates (0.7 lbs 

a.i./A and 2.1 lbs a.i./A/year, respectively) for use in standard exposure calculations. The use on 

golf course turf also allows a maximum single application rate of 0.35 lbs a.i./A with a 14-day 

minimum retreatment interval (MRI) and a maximum annual application of 2.1 lbs a.i./A/year; the 

turf use has historically resulted in the highest estimated drinking water concentrations (EDWCs) 

for human health exposure assessment. For uses where the annual maximum application rate is 

not specified on the label, or there are multiple crop cycles or rotations or differences in applicator 

practices, the annual application rate may be higher than rates that have been assumed in prior risk 

assessments. 

Boscalid was first registered in the United States under the synonym, nicobifen; its first risk 

assessment was completed in 2003 (USEPA, 2003, D278387+12). To determine if additional data 

are needed to support Registration Review, EFED examined the more recent environmental fate 

and ecological risk assessments for proposed new uses of boscalid (USEPA, 2010, D363523, 2013, 

D405817+, 2014c). EFED evaluated the full body of relevant ecotoxicity, environmental 

exposure, and usage information available to the Agency for boscalid, including ecological 

incident reports. The latest Agency science policies and risk assessment methodologies were used 

to inform the analysis plan and data recommendations. 

3. Use Characterization 

Most registered boscalid products are water dispersable granules (dry flowable) which may be 

applied via aerial spray, chemigation, ground spray, or airblast application. Certain products are 

designed for handsprayers (water soluble granules), as greenhouse foggers (aerosol), or as seed 

treatments (flowable concentrate). Terrestrial food uses of boscalid include artichoke, bulb 

vegetables, bushberry, caneberry, canola (including rapeseed), carrot (including tops), celery, 

citrus, crops grown for oil, cucurbit vegetables, dried beans, dried peas, endive, fruiting vegetables, 

grapes, head and stems brassica, hops, leafy brassica, leafy greens, lettuce, low growing berries 

(excluding cranberries), peanuts, persimmon, pome fruit, potato, root vegetables, small fruit and 

climbing vines (except kiwi), soybeans, spinach, stone fruits, strawberry, subtropical/tropical fruit, 

succulent beans, succulent peas, sunflower, tomato, tree nuts, tuberous and corm vegetables, and 

turnip greens. Boscalid may be used on ornamentals (outdoor residential, greenhouse, and 

terrestrial non-food uses) and on greenhouse tomato. Boscalid is registered for terrestrial feed 

(animal) or non-food use on many of these sites and on alfalfa, cotton, legume vegetables, and golf 

course turf. There are no registered indoor (other than greenhouse and on endive) or aquatic uses 

for boscalid. 

 

The maximum single and annual application rates for boscalid are as a root treatment for endive 

(one application at 0.02 lbs a.i./1000 lbs roots prior to cold storage and 0.03 lbs a.i./70 square feet 

of forcing tray 17.7 lbs a.i./A of forcing tray); however, this is an indoor use13 and has less 

relevance for calculating field-based EECs. The next-highest single application rates are for 

ornamentals (0.7 lbs a.i./A) and tomato (0.55 lbs a.i./A). The maximum labeled annual application 

 

12 Throughout this document, a “+” symbol following a Data Package (DP) Barcode indicates that multiple DP Barcodes are 

associated with that review. 

13 Endive is typically grown during the summer for root growth, harvested and put into cold storage until winter. The roots are planted and 

‘forced’ to grow new greens (typically in a dark barn). Therefore, this is considered an indoor use.
6 

rate is 2.1 lbs a.i./A for uses on ornamentals and golf course turf (Emerald Fungicide, EPA Reg. 

No. 7969-196). For uses where the annual maximum application rate is not specified on the label, 

the occurrence of multiple crop cycles or rotations, or differences in applicator judgment, may 

result in an annual application rate that is higher than rates that have been assumed in prior risk 

assessments. 

Boscalid has fifteen active registrations, including one technical grade product. Active 

registrations are listed in Appendix A. Some boscalid end-use products are co-formulated with 

one or more additional active ingredients: the strobilurin14 fungicide, pyraclostrobin (CAS 

Number 175013-18-0), the pyrethroid insecticide lambda-cyhalothrin (CAS Number 91465-08-

6), and the aromatic or chloronitrile fungicide chlorothalonil15. Similar to boscalid, the strobilurin 

fungicides also inhibit mitochondrial respiration but through action on a different molecular site 

(Wharton, 2010). 

A Screening Level Usage Analysis (SLUA) was prepared for boscalid in 2014 by the Biological 

and Economic Analysis Division (BEAD) (USEPA, 2014b). The SLUA summarizes agricultural 

usage information reported for boscalid during 2004-2012. These reports indicate that, on average 

during that time, most boscalid was applied on almonds, grapes, and potatoes (70,000 lbs a.i. each 

per year). Of these, almonds had the greatest percent crop treated, with an average of 40% and a 

maximum of 60% of almond crops being treated with boscalid among the states surveyed. The 

percent of crops treated with boscalid was slightly greater for strawberry (average: 60% and 

maximum: 80% treated with an average of 20,000 lbs a.i./year, in total), cherries (average: 45% 

and maximum: 70% with 20,000 lbs a.i./year, total) and caneberries (average: 45% and maximum: 

60% with 5,000 lbs a.i./year, total).

The chemical profile produced by BEAD discusses use patterns for the current uses of boscalid 

(USEPA, 2014a). In the risk assessment, EFED will use results from application scenarios that 

generate maximum exposures for a given, labeled use, unless otherwise specified. Additionally, 

in order to be protective, EFED will utilize the use information that results in maximum exposure 

(e.g., concentration) estimates for a given use pattern for the drinking water and ecological risk 

assessments. If the labels (and consequently the BEAD chemical profile) do not include all 

information needed to enable estimation of maximal exposures, such as the maximum single 

application rate, minimum application interval, annual maximum rate allowed (lbs a.i./ year), and 

application method, EFED will make conservative assumptions regarding these use parameters. 

Some boscalid use patterns are not sufficiently characterized to permit ready calculation of a 

maximum application rate per acre. More information on the following items would reduce 

uncertainty regarding such uses in the risk assessment: 

x Some labels (Reg. # 7969-197, 7969-199, SD090006) provide a maximum single application 

rate and a maximum number of applications per crop cycle or season; however, a maximum 

application rate per acre per year is not provided. It is uncertain whether the chemical may be 

applied over multiple seasons in the same year for these labels. A maximum annual application 

rate per acre or a maximum number of seasons per year is needed to permit estimation of the 

 

14 Group 11 according to the classification system of the Fungicide Resistance Action Committee (FRAC, 2012). 

15 Chlorothalonil has multi-site activity and complexes with sulphhydryl-containing proteins, leading to depletion of glutathione, a nonenzymatic 

antioxidant critical to the function of several enzymes important in detoxification and cellular respiration (Elskus, 2012).
7 

maximum amount that may be applied to a given field during one year. 

x Some labels do not include a minimum retreatment interval. 

x Some use instructions are provided on a product basis rather than an a.i. basis. Therefore, 

another product containing boscalid could be applied to the same use site. EFED recommends 

that use limitations based on an a.i. basis be included on labels. 

4. Conclusions from Previous Risk Assessments 

Previous risk assessments for boscalid have identified both acute and chronic risks to federally 

listed threatened/endangered (“listed”) and non-listed species that exceed Agency levels of 

concern (LOCs). Generally, risks from targeted (e.g., handheld) and seed treatment applications 

were determined to result in less exposure potential and thus lower risk than the more broad-scale 

agricultural and turf uses. Risks for indoor uses (greenhouse and endive) are generally addressed 

qualitatively. 

a. Ecological Risk Assessment 

Boscalid has the potential to reach surface water and groundwater, and to be transported in air via 

the vapor phase or on particles in air16. It has been measured in all of these matrices through 

monitoring. It is also characterized as persistent to very persistent, and residues are expected to 

remain in the environment for months to years. Based on boscalid’s 1) octanol-water partition 

coefficient (Kow) near 1000; 2) its organic-carbon normalized Freundlich solid-water distribution 

coefficients (KFOC) values greater than or near 1000 (mg/L)(mg/kg)-1/n; 3) previously identified 

risk concerns for sediment-dwelling organisms such as molluscs and hyallela (MRID 45405009); 

4) increased sensitivity of some sediment dwelling aquatic invertebrates as compared to aquatic 

invertebrates in the water-column; and 5) pore-water and water-column estimated environmental 

concentrations (EECs) being similar, exposure in sediment is an important exposure pathway. 

Previous ecological risk assessments for boscalid have identified acute risk to listed species of 

freshwater fish (and by extension to aquatic-phase amphibians for which fish serve as surrogates) 

and to listed species of molluscs. Chronic risk was identified for non-listed and listed freshwater 

fish and aquatic-phase amphibians and for mammals. Risks have also been identified for listed 

species of terrestrial and semi-aquatic plants and for certain non-listed species of plants (dicots). 

Adverse effects seen in chronic exposure studies with animals and with terrestrial plants generally 

reflect reductions in growth parameters following exposure to boscalid. 

A seed treatment use was assessed in 2010 (USEPA, D379809); the assessment identified chronic 

risk to mammals, contingent upon seed availability and noted uncertainties regarding the risk of 

sublethal effects in listed species of birds (and by extension to terrestrial-phase amphibians and 

reptiles for which birds serve as surrogates). 

 

16 Although boscalid is classified as non-volatile under field conditions (according to the classification system in Guideline 835.6100) (USEPA, 

2008), based on monitoring data it still has the potential to be transported in air or on particles in air. Boscalid was measured in air monitoring 

studies and was associated with particles in air (Schumer et al., 2010). Based on results of the Screening Tool for Inhalation Risk model, 

exposure through inhalation is not a potential pathway of concern for either avian or mammalian species on an acute basis. 
8 

The major environmental fate and ecological risk conclusions identified in previous assessments 

are summarized in Error! Reference source not found. and 2. 

Table 1. Potential for direct effects identified in previous assessments for boscalid1

Listed/or 

non-listed Birds2 Mammals Terrestrial Invertebrates 

Aquatic 

Vertebrates3

Aquatic 

Invertebrates 

Terrestrial 

Plants 

Aquatic 

Plants 

Non-listed C C Potential5 A*, C* A*, C* Potential* --

Listed A4, C C Potential5 A*, C* A*, C* Potential* --

A = Acute risk; C = Chronic risk; -- = Risk below LOC; * indicates a full data set is not available 

1

 Risk concerns were identified when the RQ exceeded the corresponding level of concern in a previous risk assessment or were identified as a 

potential concern based on weight of evidence. 

2

 Birds serve as surrogates for terrestrial-phase amphibians and reptiles. 3

 Fish serve as surrogates for aquatic-phase amphibians. 

4 Acute risk of sublethal effects in listed species of birds, and therefore in reptiles and terrestrial-phase amphibians, could not be precluded based 

on the submitted ecotoxicity data; however, acute risk of mortality was considered unlikely. 

5

 Based on incident data 

Table 2. Potential environmental concerns identified in previous assessments for boscalid 

Bioaccumulation1 Groundwater 

Contamination2 Sediment Persistence Residues of Concern Volatilization 

No,

log Kow<3 Yes

Yes4,

1 KFOC>1000 

L/kg 

KOW near 

1000

Yes3

Boscalid and 

Unextracted 

Residues

No

1 Based on whether previous assessments indicated this was a risk concern or if previous assessments ran Kow Based Aquatic Bioaccumulation 

Model (KABAM) for chemicals with a log Kow >3. 2 Previous risk assessments indicated that boscalid has the potential to reach groundwater; however, it did not result in drinking water concentrations 

high enough to cause a concern for human health. Boscalid has also been found in groundwater based on monitoring data. Boscalid may be both 

an exposure concern for groundwater and sediment because of its moderate mobility. 

3

 Chemicals with half-lives greater than 60 days in soil, water, and sediment are classified as “persistent” (by EPA’s Toxic Release Inventory 

Program classifications), and chemicals with half-lives greater than 180 days are considered “very persistent” (USEPA, 2012a). 4

 In previous assessments, sediment pore-water and water-column EECs were similar and a potential for risk to sediment dwelling organisms was 

identified based on the potential effects to molluscs, hyallela, and other sediment dwelling organisms. Some sediment-dwelling aquatic 

invertebrates were more sensitive than aquatic invertebrates tested in the water-column. 

b. Drinking Water Exposure Assessments 

For drinking water, Estimated Drinking Water Concentrations (EDWCs) were previously based 

on the use of boscalid on turf (USEPA, 2013, D409880; Table 3). The Health Effects Division’s 

(HED) Metabolism Assessment Review Committee (MARC) reported that the residue of concern 

for boscalid in human health drinking water is boscalid alone (Nelson et al., 2003). Unextracted 

residues were also considered a residue of concern in the drinking water assessments because a 

range of polar and nonpolar solvents used for extracting residues were not explored to determine 

if the amount of unextracted residues could potentially be available for exposure. Additionally, 

the extent to which unextracted residues consist of parent compound and/or degradate(s) is 

unknown. In 2013, surface- and groundwater-based EDWCs for boscalid plus unextracted 

residues were below the level of concern (LOC) for human health. If additional information 

becomes available that changes EFED’s understanding of the use pattern, fate inputs, residues of 

concern, or any other factors likely to result in changes to EDWCs, a new drinking water 

assessment will be conducted. If a new drinking water assessment is conducted that results in 

significant changes from previously-calculated EDWCs, HED may wish to conduct a new dietary 

exposure and/or risk assessment. 
9 

Table 3. Tier I EDWCs for residues of boscalid and unextracted residues based on use on 

turf1

Source of Drinking 

Water (Model)

Boscalid and unextracted residue concentrations in drinking water (μg/L) 

Acute Annual Average or Post Breakthrough 

Average 

Surface water (FIRST) 97.3 26.4 

Groundwater (PRZMGW) 773 697 

1 These are the highest EDWCs for the proposed and relevant previously evaluated use scenarios; see USEPA, 2013, D409880 for additional 

information (USEPA, 2013, D409880, 2014c). 

c. Clean Water Act Programs 

Boscalid is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act.17 No Total Maximum Daily Loads (TMDL) or section 

304(a) ambient water quality criteria have been developed for boscalid.18 Aquatic life 

benchmarks19 have been established for boscalid; however, any data submitted or otherwise 

located as part of the Registration Review process that indicate greater sensitivity than data 

currently available may be used to revise aquatic life benchmarks if applicable. 

5. Environmental Fate and Transport 

Boscalid has demonstrated systemic activity (translaminar and locally systemic)20 and residues are 

persistent and stable to metabolism in plants, based on available residue data reviewed by the HED. 

Boscalid has the potential to reach aquatic environments, including surface and groundwater, for 

several months or more following terrestrial application. The available data indicate that boscalid 

is likely to dissipate to some extent through various mechanisms, including runoff, erosion, and 

leaching to groundwater. Because boscalid degrades slowly in soil and aquatic systems, the 

compound may persist in soil, in water, and in benthic sediment, once transported or partitioned 

to these environmental compartments. Boscalid has a moderate mobility, coupled with its 

persistence, it has the potential to both leach and partition into sediment. 

Table 4 summarizes the physical-chemical properties of boscalid, along with the submitted 

environmental fate data (see bibliography in Appendix B). Boscalid does not dissociate at 

environmentally relevant pH, has a moderate log Kow (2.96), and is considered non-volatile from 

dry surfaces, water, and moist soil according to classification schemes in guideline OCSPP 

835.6100 (USEPA, 2008). While boscalid is classified as non-volatile based on the classification 

scheme in the terrestrial field dissipation guideline (OCSPP 835.610021) and its vapor pressure and 

 

17 Specific state causes of impairment that make up the national pesticides cause of impairment group are listed at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885. 18 Specific state pollutants that make up the National Pesticides Pollutant Group and have TMDLs are listed at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PESTICIDES. 19 Aquatic Life Benchmarks are available at http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm. 20 Lewis, J. Raspberry Cane and Fruit Rot Fungicides. Available at 

http://www.perennia.ca/Fact%20Sheets/Horticulture/Fruit/Raspberry/Raspberry%20Cane%20and%20Fruit%20Rot%20Fungicides.pdf (Accessed 

August 22, 2014). 

21 USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.6100 Terrestrial Field Dissipation. EPA 712-C-08-020. October 

2008. Office of Prevention, Pesticides, and Toxic Substances. U.S. Environmental Protection Agency. Available at 

http://www.epa.gov/opptsfrs/publications/835_6100.pdf (Accessed July 30, 2009). 
10 

air-water partition coefficient; it has been measured in air monitoring studies both in the vapor 

phase and associated with particles at low concentrations (Schumer et al., 2010). Based on its log 

Kow, it is considered unlikely to bioconcentrate in terrestrial and aquatic organisms. 

The range of half-lives for boscalid indicate that it is persistent to very persistent.22 Metabolism 

in soil under aerobic conditions is the primary route of degradation. Based on submitted studies 

boscalid is stable to abiotic routes of degradation and some biotic routes including hydrolysis, 

aqueous photolysis, soil photolysis (based on 1 soil), aerobic aquatic metabolism (based on 2 pond 

systems), and anaerobic aquatic metabolism (based on 1 pond system). 

Aerobic soil metabolism half-lives for parent alone ranged from 182 to 578 days in four soils 

(MRID 45643802). Aerobic soil metabolism rates are uncertain because 1) there were high 

amounts of unextracted residues observed in the studies (up to 45% of applied radioactivity), 2) it 

is not known whether unextracted residues have toxicity similar to that of the parent compound, 

and/or 3) a range of polar and nonpolar solvents was not explored in the extraction procedure to 

determine whether the residues are available for exposure. Therefore, degradation rates were 

estimated for parent alone and for summed residues of parent plus unextracted residues. Half-lives 

calculated by summing parent and unextracted residues ranged from 848 to 2,553 days. The same 

issue with unextracted residues was present in the anaerobic aquatic metabolism study, wherein 

unextracted residues reached a maximum of 62% of applied radioactivity (MRID 45405213). The 

half-life for parent only was 385 days and for parent plus unextracted residues there was no 

detectable degradation. 

Terrestrial field dissipation studies have been conducted at fourteen different sites for bare ground 

applications and applications to turf, peach, and almonds. Dissipation half-lives ranged from 1 

day to greater than 360 days, and carryover of residues from application to application and from 

year to year was observed at all 14 sites. There was uncertainty in the DT50 of 1 day due to the 

high variability in the measured residues. Most boscalid was observed in the top soil layer; 

however, boscalid was also observed in the lowest depth sampled (45 cm) at 3 of 14 sites. 

Boscalid is classified as moderately mobile using the FAO classification system (FAO, 2000). 

Organic-carbon normalized Freundlich distribution coefficients (KFOCs) range from 507 to 1110 

(mg/L)(mg/kg)-1/n measured in six soils (MRID 45405216).23 Boscalid may be transported to 

surface water and groundwater via runoff, leaching, and spray drift and it may also be present in 

sediment at amounts high enough to trigger the need to conduct a risk assessment for sedimentdwelling organisms24. It may be found in both surface water and sediment. Sorption coefficients 

tend to be higher in aquatic sediment than in surface soils (Allen-King et al., 2002). Mobility 

tends to decrease (i.e., sorption to increase) as organic-carbon increases in soils and sediments. 

 

22 Chemicals with half-lives greater than 60 days in soil, water, and sediment are classified as “persistent” (by EPA’s Toxic Release Inventory 

Program classifications), and chemicals with half-lives greater than 180 days are considered “very persistent” (USEPA, 2012a). 23 Soil-water distribution coefficients and organic-carbon normalized soil-water distribution coefficients were not calculated. 

24 Previoius risk assessment have indicated that pore-water and water-column EECs are similar. The potential for exposure in the water column 

and in sediment is similar. Additionally, the 40 CFR § 158.630 states that sediment data are recommended if the “...half-life of the pesticide in 

the sediment is ≤10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist: 

A. The soil partition coefficient (Kd) is ≥ 50

B. The log KOW is ൒ ͵ 

C. The KOC is ≥ 1000.”

Finally, previous risk assessments have identified risk concerns for sediment-dwelling organisms and some sediment-dwelling aquatic 

invertebrates are more sensitive than aquatic invertebrates in the water-column.
11 

Table 4. Chemical properties and environmental fate parameters of boscalid (unless 

otherwise specified) 

Parameter Value and Units Description/Comments1,2 Source (Study 

Classification)

Selected Physical/Chemical Parameters 

Chemical Class Anilide and pyridine -- -- 

PC Code 128008 -- -- 

Molecular Mass 

(g/mole) 343.21 g/mole -- -- 

Molecular Formula C18H12Cl2N2O -- -- 

Vapor pressure 2×10-6 Pa at 25o

C 

2×10-8 Torr at 25oC Non-volatile under field conditions (Mathur, 2002, 

D285692) 

Aqueous solubility 

(20o

C) 4.64 mg/L ± 0.06 mg/L at 20o

C (Mathur, 2002, 

D285692) 

Henry’s Law Constant 1×10-9 atm-m3/mol Estimated from vapor pressure at 25o

C 

and water solubility at 20o

C 

Dissociation Constant 

pKa (20o

C) 

No dissociation at environmental 

relevant pH 4 to 9 

(Mathur, 2002, 

D285692) 

Log octanol-to-water 

partition coefficient 

(Log KOW)* 

2.96 Not likely to bioconcentrate 

(Mathur, 2002, 

D285692) 

Air-water partition 

coefficient (KAW) 6 × 10-8 (log KAW = -7) Non-volatile from water surface. 

Estimated from vapor 

pressure at 25oC 

and water solubility 

at 20o

C. 

Octanol-air partition 

coefficient (KOA) 2×1010 (log KOA = 10) Estimated from KAW and KOW. 

Persistence3

Hydrolysis half-life 

25oC:

Stable, pH 5

Stable, pH 7

Stable, pH 9 

Does not hydrolyze. MRIDs 45405205

Atmospheric Half-life Hydroxyl radical reaction rate:

1 day (estimated) 

Assumed 12-hour day; 1.5×106 OH 

molecules/cm3 using EPIweb version 4.1 

(USEPA, 2009a). Boscalid is not 

expected to undergo long range transport 

in the vapor phase.2

Estimated Using 

EPIWeb Version 4.1 

Aqueous photolysis 

half-life 

22±1oC, pH 5

Stable 

Adjusted for sunlight intensity at 40qN 

latitude. 

MRIDs 45405206 

Soil photolysis halflife 22±1oC, pH 7.3:

Stable, sandy loam 

Adjusted for sunlight intensity at 40qN 

latitude. 

MRIDs 45405207
12 

Parameter Value and Units Description/Comments1,2 Source (Study 

Classification)

Aerobic soil 

metabolism half-life 

(10-30°C) 

SFO linear reg, temperature 27oC:

Parent Only (Parent+Unextracted 

Residues): 

182 (848) days, clay loam 

578 (1609) days, clay loam 

408 (1000) days, silt loam 

289 (2553) days, loam 

-- MRID 45643802 

SFO nonlinear reg, temp 20oC: 

Chloronicotinic acid 

3.3 days, sandy loam 

-- MRID 45405209 

same as 46715226 

SFO nonlinear reg, temp 20oC: 

Parent Only: 

108.3 days, sandy loam 

Not for use in modeling because only 

one replicate was used in the study. MRID 45405208 

Anaerobic soil 

metabolism half-life No Data -- -- 

Aerobic aquatic 

metabolism half-life 

19-21oC 

Stable, loamy sand sediment, pond 

water 

Stable, Loam sediment, pond area 

-- MRID 45405214 

Anaerobic aquatic 

metabolism half-life 

SFO nonlinear reg, 20oC: 

Parent (parent+unextracted residues): 

385 days (stable), sediment, North 

Dakota pond water 

-- MRID 45405213 

Acceptable

Mobility4

Organic-carbon 

normalized Freundlich 

solid-water 

distribution 

coefficient (KFOC) in 

(mg/L)(mg/kg)-1/n

Freundlich solid-water 

distribution 

coefficient (KF) in 

(mg/L)(mg/kg)-1/n 

Freundlich Exponent 

(1/n)

Soil Source 

or texture KFOC KF 1/n The relative standard deviation for KF

values (88%) was higher than the 

relative standard deviation for KFOC

values (30%). Solid-water distribution 

coefficient (Kd) and organic-carbon 

normalized solid-water distribution 

coefficients (KOC) values were not 

previously calculated. 

MRID 45405216 

Boscalid 

German 1110 27.76 0.875 

German 507 7.61 0.87 

German 594 6.5 0.84 

U.S. 987 3.9 0.89 

U.S. 655 3.28 0.86 

Canada 776 26.39 0.85 

2-chloronicotinic Acid 

MRID 45405217 

Silt loam 6 0.078 0.94 

Sandy 

loam No sorption observed 

Loamy 

sand 1 0.01 0.93 

Field Dissipation
13 

Parameter Value and Units Description/Comments1,2 Source (Study 

Classification)

Terrestrial field 

dissipation 

State/ 

Province Crop Half-life (days) 

% 

Carryover 

ON bare 30 19.8 

Highly variability in measured 

concentrations. MB bare 316 31.4 MRID 45405222 

AB bare 372 48.8 

ND bare 1 13.4 Highly variability in measured 

concentrations. MRID 45405221 

CO bare 119 24.2 

CA bare 77 19.9 

ID bare 333 52.3 -- MRID 45405220 

FL bare 27 11.9 

NJ 

bare 108 15.6 

-- MRID 45405219 

turf 44 11.8 

IL 

bare 244 16.7 

turf 155 20.1 

TX 

bare 143 21.0 

turf 108 9.1 

GA peach 282 6.2 Applications were made 

direction to the bare soil 

between orchard/vineyard 

rows at all three test sites 

(bareground plots) and to the 

orchard canopy at the Georgia 

and California test sites.

MRID 45405218 

bare 264 18.5 

NY bare 356 33.1 

CA 

almond >360 16.9 

bare 150 20.2 

Fish Bioconcentration

Fish bioconcentration 

factors (steady-state); 

depuration rate 

70x (based on total radioactivity) 

Based on total radioactivity. Value is 

not specific to boscalid. Rapid 

depuration with half-life of 1 day. 

MRID 45405007 

Analytical Methods 

ECM/ILV: Water No ILV Studies without supporting ILVs are not 

reviewed. MRID 45405227 

ECM/ILV: Soil

Residues: Parent, 2-chloronicotinic 

acid, 2-hydroxy-N-(4'-chlorobiphenyl2-y1)nicotinamide 

Solvents: Methanol followed by 50:50 

methanol:water 

Quantitation: HPLC-MS/MS

LOQ=0.01 mg/kg 

Adequate (as reviewed in DER for 

MRID 45405218) 

MRID 45405225 

(ECM) 

MRID 45405226 

(ILV) 

Storage Stability Freezer storage stability of parent, 2-

chloronicotinic acid, and 2-HydroxyN-(4'-Chlorobiphenyl-2-

yl)Nicotinamide in Soil 

Adequate (as reviewed in DER for 

MRID 45405220) 

MRID 45405223, 

45405224 
14 

Parameter Value and Units Description/Comments1,2 Source (Study 

Classification)

Stability in acetonitrile Not reviewed MRID 45405104 

AR=applied radioactivity; ECM=environmental chemistry method; ILV=independent laboratory validation; LOQ=limit of quantitation;

DER=data evaluation record; 

* Temperature or pH not reported. 

1

All estimated values were estimated according to “Guidance for Reporting on the Environmental Fate and Transport of the Stressors of Concern 

in Problem Formulations for Registration Review, Registration Review Risk Assessments, Listed Species Litigation Assessments, New Chemical 

Risk Assessments, and Other Relevant Risk Assessments” (USEPA, 2010). 2

Volatility classifications are based on classifications on the Terrestrial Field Dissipation Guideline OCSPP 835.6100 (USEPA, 2008). 3

Degradation kinetics were calculated using the single first order decay equation using either nonlinear regression of non-transformed data or 

linear regression of log-transformed data. Persistence classification are based on criteria established for the Toxic Release Inventory, which 

considers chemicals persistent if the half-life in water, soil, or sediment is greater than 60-days and very persistent if the half-life is greater than 

180-days (USEPA, 2012a). A half-life in air greater than 2-days is also considered persistent The minutes of the Scientific Advisory Panel 

examining issues related to persistent, bioaccumulative, and toxics states, “To protect against long range transport, a two-day degradation halflife in air is used internationally in regulations that identify persistent chemicals.” (USEPA, 2009b). 3

 MRID 45405210, 45405211, 454052012 are considered unacceptable. 

4

 Mobility classifications are based on Food & Agriculture Organization of the United Nations (FAO) Mobility criteria (FAO, 2000; USEPA, 

2006). 

Boscalid has been detected in surface water, groundwater, and air or associated to particles in air 

(Reilly et al., 2012; Schumer et al., 2010). Concentrations measured through monitoring studies 

were not high enough to result in a risk concern in previous risk assessments. The maximum 

boscalid concentration in surface water detected was 36 μg/L (Smalling and Orlando, 2011) and 

the maximum boscalid concentration in groundwater was 2.1 μg/L (Reilly et al., 2012). However, 

only limited data are available and those data are unlikely to have captured peak concentrations. 

Targeted surface water and groundwater monitoring data from the same areas show groundwater 

samples having similar to or higher concentrations as those observed in surface water (Reilly et 

al., 2012). 

Atmospheric samples were collected in an intensive farming area (Strasbourg, France) in April 

and May in 2007 and analyzed for 71 current-use pesticides. Boscalid was detected in 10 of 10 

samples at concentrations ranging from 0.35 to 0.81 ng/m3

 air (Schumer et al., 2010). Boscalid 

residues were associated with both atmospheric particles and the gas phase. Schumer (2010) 

reported that approximately 33% of boscalid residues were in the gas phase and 67% were in the 

particle phase. Thus, it will likely have a longer half-life in the atmosphere and may undergo long 

range transport (Schumer et al., 2010). 

a. Transformation Products 

Table 5 summarizes the transformation products observed in environmental fate studies. One 

major degradate (2-hydroxy-N-(4’-chlorobiphenyl-2-yl)nicotinamide))25 and one minor degradate 

(2-chloronicotinic acid)26 were observed in aerobic soil metabolism studies. 2-chloronicotinic acid 

is similar to a degradate (6-chloronicotinic acid) that occurs with the neonicotinoid insecticides 

(acetamiprid and imidacloprid), and a butenolide insecticide (flupyradifurone). The two 

degradates observed in the aerobic soil metabolism studies were also found in most terrestrial field 

dissipation studies. The degradate M510F49 (2-hydroxy-N-(4’-chlorophenyl-2-yl)-nicotonamide) 

was classified as a major degradate in one soil sample with a maximum amount of applied 

radioactivity associated with it being 14.4%; its aerobic soil metabolism half-life was estimated as 

 

25 Observed in all five soils. 

26 Observed in four of five soils. 
15 

1.7 days. All other boscalid degradates were classified as minor degradates. Known degradates 

were not included in the exposure calculations in previous risk assessments because they occurred 

in small amounts and were not expected to significantly alter EECs. 
16 

Table 5. Boscalid and its known environmental degradates1

Code Name/ Synonym Chemical Structure Study Type Ref. (MRID) Maximum %AR (day) Final %AR (study length) 

PARENT

Boscalid, Nicobifen, BAS 510 F IUPAC: 2-chloro-N-(4’-chlorobiphenyl-2-

yl)-nicotinamide 

CAS Number: 188425-85-6 SMILES:C1=CC=CC(=C1C2=CC=C(Cl)C=C2)NC(=O)C3=CC=CN=C3ClMW: 343.21 g/mol 

TRANSFORMATION PRODUCTS 

2-chloronicotinic acid; M510F47 CAS Number: 2942-59-8Formula: C H6 ClNO 4 2MW: 157.55 g/mol Smile string: N1=CC=CC(=C1Cl)C(=O)O 

Aerobic Soil 45643802 3.1 (371 d) 3.1 (371 d)

Terrestrial Field 45405218 <0.01 <0.01 mg/kg (360 d) Terrestrial Field 45405219 <0.01 <0.01 mg/kg (359 d) Terrestrial Field 45405220 0.04 mg/kg (21 d) <0.01 mg/kg (345 d) Terrestrial Field 45405221 0.022 mg/kg (1 d) <0.01 mg/kg (429 d) Terrestrial Field 45405222 0.019 mg/kg (1 d) <0.01 mg/kg (358 d) 

(2-hydroxy-N-(4’-chlorobiphenyl-2-yl)-

nicotonamide); M510F49

Formula: C18H13ClN O2 2MW: 324.77 g/molSMILES:C1=CC=CC(=C1C2=CC=C(Cl)C=C2)NC(=O)C3=CC=CN=C3O

Aerobic Soil 45405208 0.2 (364 d) 0.2 (364 d) Aerobic Soil 45643802 14.4 (371 d) 14.4 (371 d) 

Aerobic Aquatic 45405214 0 0 

Anaerobic 

Aquatic 45405213 0 0 

Terrestrial Field 45405218 0.02 mg/kg (13 d) <0.01 mg/kg (316 d) Terrestrial Field 45405219 0.02 mg/kg (121 d) <0.01 mg/kg (359 d) Terrestrial Field 45405220 0.03 mg/kg (7 d) 0.02 mg/kg (345 d) Terrestrial Field 45405221 0.005 mg/kg (3 d) <0.01 (429 d) Terrestrial Field 45405222 0.01 (358 d) 0.01 (358 d) 
17 

Code Name/ Synonym Chemical Structure Study Type Ref. (MRID) Maximum %AR (day) Final %AR (study length) M510F50 Unknown 2

Aerobic Soil 45405208 0.2 (364 d) 0.2 (364 d)

Anaerobic 

Aquatic 45405213 0 0 

Unextracted Residues Not Applicable 

Aerobic Soil 45405208 62.7 (266 d) 60.0 (364 d) Aerobic Soil 45643802 44.8 (371 d) 44.8 (371 d) 

Aerobic Aquatic 45405214 13.4 (100 d) 13.4 (100 d) 

Anaerobic 

Aquatic 45405213 55.1 (361 d) 55.1 (361 d) 

1 When a study is not listed for a residue, that residue was present at less than the detection limit or was not looked for in the study.
18 

6. Receptors 

A detailed description of the available ecotoxicity data for boscalid is provided in the risk 

assessment for uses on alfalfa and citrus (USEPA, 2010, D363523). Higher-tier studies 

with honey bees have been subsequently submitted and are included as lines of evidence 

in this problem formulation. Toxicity endpoints used in risk estimation for boscalid are 

summarized in Error! Reference source not found. 6 and Error! Reference source not 

und.7. These endpoints represent the most sensitive endpoints available from suitable, 

guideline toxicity studies. 

Based on the available data, boscalid is characterized as moderately toxic to freshwater fish 

(and aquatic-phase amphibians for which freshwater fish serve as surrogates) and is at least 

moderately toxic to freshwater invertebrates on an acute exposure basis, at concentrations 

approaching the chemical’s water solubility limit (4.64 mg/L at 20o

C); however, the 

submitted acute test with freshwater invertebrates (MRID 45405001) is not used 

quantitatively for risk estimation because it may have overestimated the actual exposure 

concentrations of the test organisms and thus underestimated the toxicity endpoint (see DP 

Barcode D363523 for discussion). Non-definitive toxicity endpoints indicate that boscalid 

is moderately toxic to benthic invertebrates, estuarine/marine fish and to non-mollusc 

estuarine/marine invertebrates on an acute exposure basis. However, it is highly toxic to 

estuarine/marine molluscs based on reductions in shell growth. 

Chronic exposure to boscalid resulted in reduced survival for freshwater fish, and in 

reduced survival and growth (decreased length and dry weight) and impaired reproduction 

(reduced number of young) for freshwater invertebrates (i.e., waterflea; Daphnia magna). 

Acceptable chronic toxicity data for other aquatic animals, including benthic freshwater 

invertebrates and estuarine/marine fish and invertebrates, are unavailable. Specifically, the 

chronic study for benthic freshwater invertebrates (i.e., midge; Chironomus riparius) was 

inadequate because sediment was not spiked. However, the available supplemental data 

indicate that boscalid can reduce emergence and development in the midge and reduce 

growth (decreased dry weight) in the freshwater amphipod Hyalella azteca. No chronic 

studies were submitted for estuarine/marine fish or invertebrates. 

Exposure of nonvascular aquatic plants, i.e., freshwater green algae (Pseudokirchneriella 

subcapitata) to boscalid resulted in a 50% inhibition (IC50) of cell growth at 1.34 mg/L; 

exposure of aquatic vascular plants (Lemna gibba; duckweed) to boscalid at 3.9 mg/L did 

not result in sufficient inhibition of frond growth or biomass to estimate an IC50. 

Table 6. Toxicity endpoints used in risk estimation and risk description for aquatic 

organisms exposed to boscalid residues 

Aquatic Animals (Acute Toxicity)

Study Type Species Endpoints1

(mg a.i./L)

Toxicity Classification 

(MRID) 

Acute toxicity to freshwater fish Rainbow trout

(Oncorhynchus mykiss) 96-hr LC50 = 2.7 Moderately toxic(45404927)
19 

Acute toxicity to freshwater 

invertebrate2

Waterflea

(Daphnia magna) 48-hr EC50 < 5.33 At least moderately toxic(45405001)

Acute toxicity to 

estuarine/marine fish 

Sheepshead minnow

(Cyprinidon variegatus) 96-hr LC50 > 3.86 Moderately toxic(45405004)

Acute toxicity to 

estuarine/marine invertebrates 

Mysid shrimp

(Americamysis bahia 

formerly Mysidopsis 

bahia)

48-hr LC50 > 3.81 Moderately toxic

(45405002)

Toxicity to estuarine/marine 

molluscs – shell deposition 

Eastern oyster

(Crassostrea virginica)

48-hr EC50 = 1.02

(Slope 2.14, 95% CI 

0.89 - 3.39)

Highly toxic

(45405003)

Aquatic Animals (Chronic Toxicity)

Study Type Species 

NOAEC & 

LOAEC 

(mg a.i./L) 

Effects 

(MRID) 

Early life stage toxicity to 

freshwater fish 

Rainbow trout

(Oncorhynchus mykiss) 0.116 & 0.241 Mortality(45405006)

Chronic toxicity to freshwater 

invertebrates 

Waterflea

(Daphnia magna) 0.79 & 1.54 Reduced number of young 

(46351406)

10-day sediment toxicity to 

freshwater invertebrates 

Freshwater amphipod

(Hyalella azteca)

EC50 > 1.066

NOAEC = 0.298

(pore water)

Dry weight

Moderately toxic

(45405009)

Chronic toxicity to sedimentdwelling invertebrates (spiked 

water) 

Freshwater midge

(Chironomus riparius)

2.0 & 4.0 nominal 

(overlying water)

Reduced emergence

(45405008)

Aquatic Plants 

Study Type Species Endpoints 

(mg a.i./L) Effects (MRID) 

Toxicity to vascular aquatic 

plants 

Duckweed

(Lemna gibba)

IC50 > 3.9

NOAEC = 0.99

Frond number, necrosis 

(45405013)

Toxicity to nonvascular aquatic 

plants 

Freshwater alga

(Pseudokirchneriella 

subcapitata)

IC50 = 1.34

NOAEC = 0.49

Growth rate, biomass

(45405017)

1

 Dose-response slope values for the estuarine/marine mollusc are indicated in parentheses (value, 95% confidence interval). For other 

studies, where slope data are not available, the default value of 4.5 (with 95% confidence intervals of 2.0 and 9.0) is used to derive the 

probability of an individual effect for aquatic animals (Urban and Cook 1986). 

2

 The acute toxicity data for freshwater invertebrate (MRID 45405001) are not used quantitatively in risk estimation because they likely 

underestimate toxicity (see DP Barcode D363523 for discussion). 

Based on the available data, boscalid is practically non-toxic to terrestrial invertebrates 

(e.g., young adult honey bees) on both an acute contact and acute oral exposure basis. The 

compound is also practically non-toxic to birds on both an acute oral and subacute dietary 

exposure basis, and to mammals on an acute oral exposure basis. However, adverse effects 

on honey bee larval development (e.g., reduced queen cell development) have been 

reported in incident data following application of boscalid, specifically as the Pristine®

formulation (boscalid + pyraclostrobin), to almonds and other unspecified crops. EFED 

subsequently reviewed a series of special honey bee toxicity and foliar residue studies with 

boscalid and the Pristine® formulation, as follows (DP Barcode D927620 and D420653): 

x Bocksch, S. 2012. Determination of side-effects of BAS 510-01 F on brood 

development of the honeybee (Apis mellifera L.) in a feeding study (MRID 
20 

49009301); 

x Niederdrenk, S. and C. W. Schneider. 2012. Assessments of effects of BAS 516 

04 F on the production of honey bee queens (Apis mellifera L.) in a semi field study 

in Phacelia tanacetifolia (MRID 49009303); 

x Lawrence, J. and M. Riley. Determination of residues of Pristine fungicide 

(Pyraclostrobin + Boscalid) in royal jelly and pollen in almond tree in central 

California (MRID 49009304); and, 

x Royer, S. 2014. Effect of Reg. No. 300355 (BAS 510F) on survival and 

development of honey bee brood (Apis mellifera), using an in vitro rearing method 

(MRID 49361801). 

Generally, the current suite of higher-tier tests with boscalid and the Pristine® formulation 

does not support the claims regarding diminished honey bee queen cell production in 

colonies exposed to any one of these products alone. 

In birds and mammals, chronic exposure to boscalid was associated with reproductive and 

growth effects, including reduced number of eggs and embryo mortality in bobwhite quail 

(Colinus virginianus) and reduced body weight in second generation offspring (F2) in rats 

(Rattus norvegicus). Based on the results of the Tier II terrestrial plant studies, cabbage 

(Brassica oleracea) appears to be particularly sensitive to boscalid exposure, while other 

dicot species and all tested monocots are relatively insensitive to boscalid exposure. 

Table 7. Toxicity endpoints used in risk estimation and description for terrestrial 

organisms exposed to boscalid 

Terrestrial Animals (Acute Toxicity)

Study Type Species 

Endpoints1

(LD50 mg a.i./kg bw) 

(LC50 mg a.i./kg 

diet)

Toxicity Classification 

(MRID) 

Acute oral toxicity to 

upland game birds 

Bobwhite quail

(Colinus virginianus) LD50 > 2000 Practically nontoxic (45404922) 

Subacute dietary toxicity 

to upland game birds and 

waterfowl 

Bobwhite quail

(Colinus virginianus)

Mallard duck

(Anas platyrhynchos)

LC50 > 5000

Practically nontoxic 

(45404923) 

(45404924) 

Acute oral toxicity to 

mammals2

Norway rat

(Rattus norvegicus) LD50 > 5000 Practically nontoxic (45404814) 

Acute contact and oral 

toxicity to honey bees 

Honey bee

(Apis mellifera)

LD50 > 166 μg/bee

(oral)

LD50 > 200 μg/bee

(contact)

Practically non-toxic 

(45405019) 

Toxicity to soil dwelling 

invertebrates (14-day)3

Earthworm

(Eisenia foetida)

LD50 > 1000 mg 

a.i./kg dry weight 

soil (nominal)

NA 

(45405020) 

Terrestrial Animals (Chronic Toxicity)

Study Type Species 

NOAEC 

(mg a.i./kg diet) 

NOAEL 

(mg a.i./kg bw) 

Effects 

(MRID) 
21 

Avian reproduction with 

upland game birds

Bobwhite quail

(Colinus virginianus) 

NOAEC = 300

NOAEL = 25

Number of eggs laid, 

fertility rate, embryo 

mortality, and number 

of 14-day survivors 

(45404925) 

Chronic toxicity to 

mammals2 – twogeneration reproduction 

Norway rat 

(Rattus norvegicus) 

NOAEC = 100

NOAEL = 11.2

Decreased F2 body 

weight 

(45404906) 

Terrestrial Plants 

Study Type Most Sensitive 

Species 

IC25 & NOAEC 

(lbs a.i./A) Effects (MRID)

Tier II seedling emergence 

(Emerald, 69.9% a.i.) 

Monocot: Corn

Dicot: Cabbage

> 0.576 & 0.275

0.44 & 0.275

Seedling emergence 

Dry weight 

(47627401) 

Tier II vegetative vigor 

(Emerald, 69.9% a.i.) 

Monocot: Corn

Dicot: Cabbage

> 0.626 & 0.035

< 0.035 & <0.035

Shoot length 

Dry weight 

(47627402) 1

 Slope data were not available from the acute terrestrial animal studies. The default value of 4.5 (with 95% confidence intervals of 

2.0 and 9.0) is used to derive the probability of an individual effect (Urban and Cook 1986). 

2 Mammalian toxicity data provided and reviewed by OPP Health Effects Division (USEPA). 

3

 The submitted earthworm study was labeled as an acute test, although the duration (14 days) was considerably longer than most

acute toxicity tests with invertebrates. The guideline-recommended duration for a chronic test with earthworms is 28 days. 

a. Ecological Incidents 

The risk assessment will incorporate information from reports of ecological incidents 

associated with boscalid use. This information may come from sources such as the 

Agency’s Ecological Incident Information System (EIIS), OPP’s aggregate incident report

database, or external portals such as the Avian Incident Monitoring System (AIMS) or the 

National Pesticide Information Center (NPIC). 

The EIIS is an internal OPP database that houses ecological incidents that have been 

reported to the Agency. When available, EIIS includes date and location of an incident, 

type and magnitude of effects observed in various species, use(s) of pesticides known or 

suspected of contributing to the incident, and results of any chemical residue analysis or 

other analyses conducted during incident investigation. EIIS incidents are categorized 

according to the certainty that the incident resulted from pesticide exposure. A search of 

the EIIS for ecological incidents run on August 12, 2014, identified six incidents of adverse 

effects on honey bees potentially associated with exposure to boscalid; in several cases, 

residues of multiple pesticides, including insecticides, were detected in bee tissue and wax 

samples. Other incidents may have occurred due to boscalid exposures but may not have 

been reported due to various factors, such as a lack of reporting, or a lack of observation 

of effects. Therefore, the lack of incident reports does not necessarily indicate the absence 

of incidents. 

No plant or wildlife incidents have been reported through OPP’s aggregate incident report 

database and no avian incidents have been captured in the Avian Incident Monitoring 

System (AIMS; American Bird Conservancy 2013)27 as of August 12, 2014. The AIMS 

 

27 Available at: http://www.abcbirds.org/abcprograms/policy/toxins/aims/aims/index.cfm
22 

database contains publicly available reports on pesticide-related avian incidents through 

2005. 

7. Exposure Pathways of Concern 

For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically 

significant concentrations. An exposure pathway is the means by which a pesticide moves 

in the environment from a source to an ecological receptor. For an ecological pathway to 

be complete, it must include a source, a release mechanism, an environmental transport 

medium, a point of exposure for ecological receptors, and a feasible route of exposure. 

The environmental fate properties of boscalid indicate the following transport mechanisms 

for potential exposure to aquatic and terrestrial organisms: 

x Direct contact with residues on foliar and other surfaces 

x Spray drift28

x Runoff 

x Discharge of contaminated groundwater 

Terrestrial organisms may be exposed to boscalid in dietary items, in surface water, and 

sediment. Based on the results of screening tools29,30, inhalation and drinking water for 

non-target organisms are not, by themselves, expected to be significant exposure pathways 

for boscalid (Appendix D and Appendix E). 

8. Analysis Plan 

The uses, environmental fate, and ecological effects of boscalid are characterized and 

integrated to assess the risks. Risk is expressed using the ratio of exposure concentration 

to effects concentration, referred to as a Risk Quotient (RQ). Although risk is often defined 

as the likelihood and magnitude of adverse ecological effects, the RQ-based approach does 

not provide a quantitative estimate of likelihood and/or magnitude of an adverse effect. 

However, as outlined in the Overview Document (USEPA, 2004), the likelihood of effects 

to individual organisms from particular uses of boscalid is estimated using the probit doseresponse slope and either the level of concern (discussed below) or calculated RQ value. 

The analysis plan outlined in this problem formulation may be revised depending upon 

information submitted by the public in response to the opening of the Registration Review 

docket for boscalid. 

 

28 Boscalid has been detected in the vapor phase in air monitoring studies, but based on other data including its low acute toxicity to 

mammals and birds, volatilization is not considered to be a transport mechanism of concern. 

29 Screening Tool for Inhalation Risk (STIR v.1.0, November 19, 2010) 

30 Screening Imbibition Program (SIP v.1.0, released June 15, 2010)
23 

a. Stressors of Concern 

i. Ecological Risk Assessment 

The stressors of potential concern for non-target organisms are boscalid and unextracted 

residues given that the identity of the unextracted residues is uncertain. The only two 

transformation products observed in fate studies, that occurred at greater than 1% applied 

radioactivity, were 2-chloronicotinic acid and 2-hydroxy-N-(4’-chlorobiphenyl-2-yl)-

nicotonamide). Both of these residues were observed sporadically in fate studies and at 

very low levels at most sampling times. Including these residues in a total toxic residue 

approach, is not expected to significantly alter exposure estimates. Therefore, these 

residues were not considered residues of concern. Additionally, no available data on these 

degradates suggest that these residues would be more toxic than the parent. 

The residues of concern are boscalid and unextracted residues. EFED will use a total toxic 

residues (TTR) approach for assessing risk to boscalid and unextracted residues in water. 

EFED will also estimate exposure for residues of boscalid alone, to get a better 

understanding of the uncertainty in exposure due to inclusion of unextracted residues in 

exposure assessments. This is consistent with the approach taken in previous assessments 

completed for boscalid. 

ii. Drinking Water 

As discussed previously, the MARC reported that the residue of concern for boscalid in 

human health drinking water is boscalid only (Nelson et al., 2003). Unextracted residues 

were also considered a residue of concern in previously completed drinking water 

assessments because a range of polar and nonpolar solvents were not explored to determine 

if the amount of unextracted residues could be decreased and the identity of the unextracted 

residues is unknown. EFED will use a TTR approach for estimating drinking water 

concentrations for human health. EFED will also estimate exposure to residues of boscalid 

alone, to gain a better understanding of the uncertainty in exposure due to inclusion of 

unextracted residues. This is consistent with the approach taken in previous drinking water 

assessments for boscalid. 

b. Measures of Exposure 

EFED will use standard available models (identified in Table 8) to evaluate potential 

exposures to aquatic and terrestrial organisms as described at 

http://www.epa.gov/pesticides/science/models_db.htm. 

Since the times when most of the previous exposure assessments were completed, two main 

changes in standard procedures have been made: 

1) The North American Free Trade Agreement (NAFTA) Guidance for Evaluating and 

Calculating Degradation Kinetics in Environmental Media (NAFTA, 2012; USEPA, 
24 

2012c) was completed. Degradation kinetics may be recalculated consistent with the 

updated approach. 

2) A new model for estimating concentrations in surface water was developed called the 

Surface Water Concentration Calculator (SWCC) (USEPA, 2014d). This model is an 

updated version of the standard model used in EFED to estimate exposure to pesticides 

in the aquatic environment. 

The most up-to-date procedures and models will be used in the Registration Review 

exposure assessments. Nonstandard modeling procedures that may be used in the risk 

assessment are discussed below. In the absence of chemical-specific data, the T-REX 

model will employ the standard default 35-day foliar dissipation half-life. 

Aquatic Assessment for Uses in Residential Areas

At the present time, EFED considers the use of the impervious scenario (a Pesticide Root 

Zone Model (PRZM) modeling scenario) as the most suitable available modeling approach 

for impervious runoff. This procedure was originally developed for the assessments 

completed for listed species in California.31 The PRZM impervious scenario may be used 

in the SWCC along with a residential or other suitable scenario such as rights-of-way 

(ROW) to obtain EECs. The conceptual model for the residential scenario integrates 

simultaneous modeling of the individual use scenario with an impervious scenario. This 

approach assumes that no watershed is completely covered by either 1⁄4-acre lots (the basis 

for the residential scenario) or undeveloped land (the basis for the ROW scenario) for 

residential and ROW use patterns; therefore, differential amounts of runoff will occur 

within the watershed. The impervious scenario was developed to represent the paved areas 

within a watershed not including roads, parking lots, sidewalks, and buildings outside the 

1⁄4-acre lot (the 1⁄4-acre lot scenario accounts for impervious surfaces such as buildings 

within the represented area). By modeling a separate scenario for impervious surfaces, it 

is also possible to estimate that amount of exposure that could occur when the pesticide is 

over-sprayed onto this surface. Using two scenarios in tandem requires post-processing of 

the modeled output in order to derive a weighted EEC that represents the contribution of 

both the pervious (i.e., residential and ROW scenarios) and the impervious surfaces. The 

scenario assumes that a portion of the residential or ROW area is treated and a portion of 

impervious surface is treated. Exposure from both scenarios can also be weighted and 

aggregated. The daily time series from each SWCC model run for the residential and 

impervious surface scenarios are combined in a spreadsheet. The time-series data are 

weighted and summed based on assumed percentage of impervious surface, the percentage 

of the pervious surface treated, and percentage of each area treated. Exposures for the 

relevant durations (e.g., 1-day, 21-day and 60-day 1-in10 year return frequency 

concentrations) are then calculated from the composite time series in the standard fashion. 

Irrigation Water 

EFED does not currently have a standardized methodology for determining risk to nontarget plants from applications of irrigation water where surface or groundwater has been 

 

31 http://www.epa.gov/espp/litstatus/effects/redleg-frog/ 
25 

contaminated by a pesticide applied to crops. However, EFED anticipates that an irrigation 

water analysis will be conducted at the time of the risk assessment using exposure values 

generated from currently available models such as the SWCC or PRZM-Groundwater 

(PRZM-GW) for groundwater exposures. This approach will be used to determine a depth 

(in inches) of irrigation water on a one-acre field necessary to cause an LOC exceedance 

to terrestrial plants and compared with representative cultural practices to characterize the 

potential risk associated with this exposure scenario. 

Table 8. List of the various models and the related taxa for which the models will be 

used 

Environment Taxa of 

Concern 

Exposure 

Pathway 

Model(s) or 

Pathway Link

Aquatic

Fish/ 

Invertebrates/ 

Plants

Runoff and spray 

drift to water SWCC http://www.epa.gov/oppefed1/model

s/water/

Terrestrial

Vertebrate Residues in/on 

dietary items

T-REX (dietary 

item)

http://www.epa.gov/oppefed1/model

s/terrestrial/trex/trex_v1_5_webversi

on.xlsm

Plant

Runoff and spray 

drift to plants TerrPlant (Run-off) http://www.epa.gov/oppefed1/model

s/terrestrial/index.htm#terrplant

Residues in 

irrigation water 

Results from 

Aquatic Models

http://www.epa.gov/oppefed1/model

s/water/

Human Health 

EDWC Vertebrate 

Surface Water SWCC 

http://www.epa.gov/oppefed1/model

Groundwater s/water/ SCIGROW 

PRZM-GW 

All 

Environments All Spray Drift

AgDRIFT (Spray 

drift) 

http://www.agdrift.com/AgDRIFt2/D

ownloadAgDrift2_0.htm

AGDISP (Spray 

drift) 

http://www.continuumdynamics.com/pr-agdisp.html

Available Monitoring Data 

The Agency is aware of pesticide monitoring conducted by federal and state agencies. This 

information will be considered in the assessment, to the extent that data on boscalid are 

available. 

c. Measures of Effect 

Toxicity data presented in Section 3 of this problem formulation will be used to calculate 

RQ values. Any additional information submitted by the registrant or found in the open 

literature prior to conduct of the risk assessment and meeting the standards established by 

the Agency will also be considered. The open literature studies are identified using EPA’s 

ECOTOXicology database (ECOTOX)32, which employs a literature search engine for 

 

32 http://cfpub.epa.gov/ecotox/
26 

locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The 

evaluation of both sources of data can also provide insight into the direct and indirect 

effects of pesticides on biotic communities from loss of species that are sensitive to the 

chemicals and from changes in structure and functional characteristics of the affected 

communities. 

9. Endangered Species Assessments 

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the 

Agency will evaluate risks to listed species from registered uses of pesticides in 

Registration Review. The process for evaluating potential risks to listed species is further 

described at http://www.epa.gov/oppfead1/endanger/litstatus/riskasses.htm. 

10. Endocrine Disruptor Screening Program (EDSP) 

Boscalid was not included in the first group of 67 chemicals issued an order to conduct 

Tier 1 EDSP testing. For additional information on the EDSP, visit 

http://www.epa.gov/endo/. 

11. Preliminary Identification of Data Gaps 

a. Environmental Fate 

Table 9 identifies environmental fate studies by master record identification (MRID) 

number that offer data for each guideline requirement, as well as study classifications and 

whether or not further data are needed in order to support risk assessment. 

Whether unextracted residues may be available for exposure is unknown in a number of 

submitted fate studies in which unextracted residues made up greater than 10% of applied 

radioactivity (<1 to 63%). This creates significant uncertainty in the risk assessment. 

Due to the uncertainty regarding the identity of the unextracted residues and potential for 

exposure to unextracted residues, past assessments for boscalid have conservatively 

assumed that the unidentified residues are of toxicological concern when estimating halflives for use in aquatic modeling. Additionally, past assessments of boscalid have 

conservatively assumed that unextracted residues exhibit the same toxicity to aquatic 

organisms as the parent compound. Including the unextracted residues in the exposure 

estimate does change certain conclusions for ecological risk. Additionally, a range of 

polar and nonpolar solvents was not utilized in the extraction procedures, causing 

uncertainty as to whether the unextracted residues may be available for exposure to nontarget organisms. Additional aerobic soil metabolism data and anaerobic aquatic 

metabolism data are needed to better illuminate this uncertainty. Aerobic soil 

metabolism and anaerobic aquatic metabolism studies employing a range of polar and 

nonpolar solvents for extraction would address this concern. 
27 

Table 9. Submitted environmental fate data and study classifications for boscalid 

and transformation products1

OCSPP 

Guideline Data Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed to 

conduct risk 

assessment? 

Justification and Assumptions EPA 

will Make in Absence of Data

835.2120 Hydrolysis 45405205 Acceptable No -- 

835.2240 Aqueous photolysis 45405206 Acceptable No

835.2410 Soil photolysis 45405207 Acceptable No 

835.2370 Photodegradation 

in Air No Data -- No -- 

835.4100 Aerobic soil 

metabolism

45643802 

(4 soils) Acceptable

Yes

The most recently completed ecological 

risk assessment indicated that assuming 

that the unextracted residues were 

parent affected EECs and subsequent 

risk conclusions. Therefore, data to 

reduce this uncertainty would be useful 

in future risk assessments. See text 

above table for additional information 

on this uncertainty.

45405209 

same as 

46715226 

(Data for 2- 

CNA) 

Supplementalmay be used in 

modeling

45405208 

(1 soil)

MRID 45405208 

Supplemental –

not for use in 

modeling 

835.4200 Anaerobic soil 

metabolism 

45405211 Unacceptable No -- 45405212 Unacceptable 

835.4300 Aerobic aquatic 

metabolism 45405214 Supplemental No -- 

835.4400 Anaerobic aquatic 

metabolism 45405213 Acceptable Yes

The test guideline (OCSPP 835.4400) 

for anaerobic aquatic metabolism 

recommends data in two sediments; 

however, data are currently only 

available for one sediment. This data 

gap could result in underestimation or 

overestimation of typical half-lives in 

such media. To account for this 

uncertainty, standard EFED procedure 

is to multiply a single anaerobic aquatic 

metabolism half-life by three to derive a 

representative benthic half-life for use 

as a model input. Additionally, there is 

currently uncertainty in whether 

unextracted residues are available for 

potential exposure. This uncertainty 

could be minimized with additional data 

on another sediment using extraction 

techniques that explore a range of polar 

and nonpolar solvents. Including 

unextracted residues for the benthic 

metabolism in EECs doubles the EEC 

and can impact risk conclusions. 
28 

OCSPP 

Guideline Data Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed to 

conduct risk 

assessment? 

Justification and Assumptions EPA 

will Make in Absence of Data

835.1230

835.1240

Adsorption/ 

desorption and 

leaching

45405216 

(6 soils)

Supplementalmay be used in 

modeling 

No -- 

45405217 

(2-CNA, 2 

soils) 

Supplemental –

may be used in 

modeling 

No -- 

835.1410 Volatility –

laboratory No Data -- No

Not expected to be volatile under 

normal use conditions based on low 

vapor pressure and Henry’s Law 

Constant. While it has been observed in 

air in monitoring studies, the 

concentrations were below levels were 

effects could occur.2

835.6100 Terrestrial field 

dissipation

45405218 Supplemental 

No

-- 

45405219 Acceptable -- 

45405220 Acceptable -- 

45405221 Acceptable -- 

45405222 Supplemental -- 

835.6200 Aquatic field 

dissipation 45405215 Unacceptable No No direct applications to water.
29 

OCSPP 

Guideline Data Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed to 

conduct risk 

assessment? 

Justification and Assumptions EPA 

will Make in Absence of Data

850.6100

Analytical method 

for soil

45405225 

(ECM) 

45405226 

(ILV) 

 Yes 

Submitted studies are inadequate to 

serve as the analytical method for soil. 

The LOQ of 0.01 mg/kg-soil (0.02 lbs 

a.i./A) is insufficient to cover the lowest 

measured terrestrial plant endpoint of 

0.0004 lbs a.i./A (0.0002 mg/kg-soil) 

assuming a 1.5 g/mL soil density and 

six-inch soil depth (MRID 47627402) 

(USEPA, 2012b). However, the lowest 

available endpoint is a greater than (>) 

value and nondefinitive. The final 

endpoint may be lower than 0.0004 lbs 

a.i./A. Assuming that it may be as 

much as an order of magnitude lower, 

an analytical method with an LOQ of 

0.02 μg a.i./kg soil is needed. 

Analytical method 

for water

45405227 

(ECM) 

Not reviewable 

because an ILV 

is not available. 

Yes 

The lowest aquatic endpoint is 0.298 

mg/L for sediment pore-water (MRID 

45405009). An ECM in water with an 

LOQ less than 0.298 mg/L is 

recommended to be available for 

monitoring because a potential for risk 

to aquatic organisms have been 

identified in previous risk assessments 

(USEPA, 2012b). In addition, the ILV 

component of this data requirement is 

needed.

Analytical method 

for sediment Not submitted -- Yes 

An ECM and ILV are needed to 

facilitate monitoring of residues of 

boscalid in sediment because there is a 

potential risk to sediment dwelling 

organisms in previous risk assessments 

(USEPA, 2012b). 

850.1730 Fish 

bioconcentration 45405007 Acceptable No -- 

ILV=independent laboratory validation; ECM=environmental chemistry method; 2-CNA=2-chloronicotinic acid 

1

 The study was conducted on the parent unless otherwise specified. 

2

 Based on the results of the STIR model. 

b. Effects 

Table 10 identifies ecological effects studies with boscalid, by MRID (or Accession 

number), for each guideline requirement, as well as study classifications and whether or 

not additional data are needed in order to support risk assessment. The rationale for any 

additional data requested is presented below the tables. 
30 

Table 10. Submitted ecological effects data for boscalid

Guideline Description—Test 

Substance

MRID or 

Acc. No. 

Study 

Classification 

Are data 

Needed for 

Risk 

Assessment? 

Comments 

(Justification and Assumptions 

EPA will Make in Absence of 

Data) 

Avian and Mammalian Testing 

71-1

(850.2100) 

Avian acute oral 

toxicity, waterfowl 

—TGAI 

None N/A No

Other lines of evidence (data 

subacute dietary exposure and 

avian reproduction) suggest that 

waterfowl are no more sensitive 

to boscalid exposure than the 

upland game species tested. 

71-1

(850.2100) 

Avian acute oral 

toxicity, upland 

game bird species 

—TGAI 

45404922 Acceptable No

850.2100 

Avian acute oral 

toxicity, passerine 

species—TGAI 

None N/A No

Open literature data described in 

D405817+ indicate that acute risk 

of mortality to passerine birds is 

likely low. 

Nonguideline 

Avian acute 

inhalation toxicity, 

most sensitive 

species from oral 

toxicity tests -- 

TGAI 

None N/A No

Inhalation is not identified by 

STIR as a significant exposure 

route for boscalid. 

850.2200 

Avian dietary 

toxicity, waterfowl 

species—TGAI 

45404924 Supplemental No

Classified as supplemental due to 

poor rearing conditions and small 

sample size. However, the LC50

was greater than the highest test 

concentration (LC50>5,000 mg 

a.i./kg diet), and new data would 

be unlikely to impact the risk 

assessment. 

Avian dietary 

toxicity, upland 

game bird—TGAI 

45404923 Supplemental No

Classified as supplemental due to 

poor rearing conditions and small 

sample size. However, the LC50

was greater than the highest test 

concentration (LC50>5,000 mg 

a.i./kg diet), and new data would 

be unlikely to impact the risk 

assessment.

71-4

(850.2300) 

Avian reproduction, 

waterfowl 

species—TGAI 

45404925 Acceptable No

71-4

(850.2300) 

Avian reproduction, 

upland game bird 

species—TGAI 

45404925 Acceptable No
31 

Guideline Description—Test 

Substance

MRID or 

Acc. No. 

Study 

Classification 

Are data 

Needed for 

Risk 

Assessment? 

Comments 

(Justification and Assumptions 

EPA will Make in Absence of 

Data) 

850.2400 Wild mammal 

toxicity—TGAI None N/A No

EFED is not currently 

recommending a wild mammal 

toxicity test per OCSPP 

850.2400. Instead, EFED will 

evaluate risk to mammals based 

on toxicity data for laboratory rat 

or other mammals tested. EFED 

will consult with HED to identify 

the most appropriate acute and 

chronic toxicity endpoints. 

850.2500 Simulated or actual 

field testing—TEP None N/A No

Not triggered based on 

ecotoxicity data, predicted EECs, 

fate properties, and use pattern 

criteria. 

Aquatic Animal Testing 

72-2

(850.1010) 

Freshwater 

invertebrate, acute 

toxicity—TGAI 

45405001 Supplemental Yes

Precipitate not 

filtered/centrifuged; water 

quality; uncertainty with 

measured concentrations. Data 

are not suitable for quantitative 

use in risk assessment.

72-2

(850.1010) 

Freshwater 

invertebrate, acute 

toxicity—TEP 

None N/A 

Yes

(TEP 

containing

boscalid + 

pyraclostrobin)

Rat acute oral studies indicate 

that when boscalid is coformulated with pyraclostrobin 

and/or lambda-cyhalothrin, the 

LD50 values measured for the coformulated products are lower 

than the LD50 for boscalid alone. 

Therefore, EPA recommends 

data on a representative typical 

end-use product containing 

boscalid+pyraclostrobin. In the 

absence of data, EFED may 

assume that hazard and risk is 

greater from exposure to this type 

of end product than from 

exposure to boscalid alone. 
32 

Guideline Description—Test 

Substance

MRID or 

Acc. No. 

Study 

Classification 

Are data 

Needed for 

Risk 

Assessment? 

Comments 

(Justification and Assumptions 

EPA will Make in Absence of 

Data) 

72-2

(850.1010) 

Freshwater 

invertebrate, acute 

toxicity—TEP 

None N/A 

Yes

(TEP 

containing

boscalid + 

pyraclostrobin

+ lambdacyhalothrin)

As noted in D398874, lambdacyhalothrin is a pyrethroid, a 

class of chemicals that is known 

to exhibit greater than additive 

toxic effects when applied with 

other chemicals. Additionally, 

rat acute oral studies indicate that 

when boscalid is co-formulated 

with pyraclostrobin and/or 

lambda-cyhalothrin, the LD50

values measured for the coformulated products are lower 

than the LD50 for boscalid alone. 

Therefore, EPA recommends 

data on a representative typical 

end-use product containing 

boscalid+lambacyhalothrin+pyraclostrobin. In 

the absence of data, EFED may 

assume that hazard and risk is 

greater from exposure to this type 

of end product than from 

exposure to boscalid alone. 

72-2

(850.1010) 

Freshwater 

invertebrate, acute 

toxicity—TEP 

None N/A 

Yes

(TEP 

containing

boscalid + 

chlorothalonil)

EPA recommends data on a 

representative typical end-use 

product containing 

boscalid+chlorothalonil. In the 

absence of data, EFED may 

assume that hazard and risk is 

greater from exposure to this type 

of end use product than from 

exposure to boscalid alone. 

72-3

(850.1025) 

Estuarine/Marine 

Mollusc acute 

toxicity—TGAI 

45405003 Acceptable No

72-3

(850.1035) 

Estuarine/Marine 

crustacean acute 

toxicity—TGAI 

45405002 Acceptable Yes

The study yielded a nondefinitive 

endpoint (LC50 > 3,810 μg a.i./L); 

the ratio of the highest 

concentration tested to previously 

calculated EECs is not high 

enough to evaluate risk to listed 

species for some uses.

850.1075 

Freshwater fish, 

acute toxicity, 

warm water 

species—TGAI 

45404928 Supplemental No

Classified as supplemental due to 

water quality deviations and 

uncertainty with measured 

concentrations. New data are not 

recommended at this time 

because they are unlikely to 

impact the risk assessment.
33 

Guideline Description—Test 

Substance

MRID or 

Acc. No. 

Study 

Classification 

Are data 

Needed for 

Risk 

Assessment? 

Comments 

(Justification and Assumptions 

EPA will Make in Absence of 

Data) 

850.1075 

Freshwater fish, 

acute toxicity, cold 

water species—

TGAI 

45404927 Supplemental No

Classified as supplemental due to 

absence of measured 

concentrations. New data are not 

recommended at this time. 

850.1075 

Estuarine/Marine 

fish acute 

toxicity—TGAI 

45405004 Acceptable No

The study yielded a nondefinitive 

endpoint (LC50 > 3,860 ug a.i./L); 

the ratio of the highest 

concentration tested to previously 

calculated EECs is not high 

enough to evaluate risk to listed 

species for some uses. In the 

absence of additional data on 

acute toxicity to estuarine/marine 

fish, EPA may use an acute-tochronic ratio for freshwater fish 

to assess acute risk to 

estuarine/marine fish.

72-4

(850.1300) 

Freshwater 

invertebrate, 

reproduction test—

TGAI 

46351406 Acceptable No

850.1350 

Estuarine/marine 

invertebrate, 

reproduction test—

TGAI 

None N/A Yes

In the absence of data, EPA will 

be unable to assess chronic risk to 

estuarine/marine invertebrates. 

Risk may be assumed. 

850.1400 

Freshwater fish, 

early life stage 

test—TGAI 

45405006 Supplemental No

Classified as supplemental due to 

water quality deviations and 

uncertainty with measured 

concentrations. New data are not 

recommended at this time 

because they are unlikely to 

impact the risk assessment

850.1400 

Estuarine/marine 

fish, early life stage 

test—TGAI 

None N/A Yes

In the absence of data, EPA will 

be unable to assess chronic risk to 

estuarine/marine fish. Risk may 

be assumed. 

850.1500 Freshwater fish life 

cycle test None N/A Yes

Aquatic EECs (up to 152 ug a.i./L 

in D416697+) exceed the FW fish 

early life-stage (ELS) NOAEC 

(116 μg a.i./L); a full life cycle 

test is recommended when the 

EEC is at least one-tenth the 

NOAEC. A protocol should be 

submitted for review prior to test 

initiation.
34 

Guideline Description—Test 

Substance

MRID or 

Acc. No. 

Study 

Classification 

Are data 

Needed for 

Risk 

Assessment? 

Comments 

(Justification and Assumptions 

EPA will Make in Absence of 

Data) 

Estuarine/marine 

fish life cycle test None N/A No

This data recommendation may 

be triggered in the future 

depending on results of the e/m 

early life stage test. 

850.1950 

Simulated or actual 

field testing for 

aquatic organisms 

None N/A No

Not triggered based on 

ecotoxicity data, predicted EECs, 

fate properties, and use pattern 

criteria. 

Sediment Testing

850.1735 

Whole sediment 10-

d freshwater 

invertebrate—

TGAI 

45405009 Supplemental No

Classified as supplemental 

because boscalid recoveries 

varied substantially based on 

analytical method; solvent 

controls sig. different from 

negative controls. Given 

boscalid’s persistence, a chronic 

study is recommended (see 

below).

850.1740 

Whole sediment 10-

d estuarine/marine 

invertebrate—

TGAI 

None N/A No

Given boscalid’s persistence, it is 

recommended that the registrant 

proceed directly to a chronic 

sediment test (see below).

Agency-wide 

guideline 

Whole sediment 

chronic freshwater 

estuarine/marine 

invertebrate (three 

species) —TGAI 

45405008 Supplemental Yes

Earlier submission classified as 

supplemental because boscalid 

was applied to overlying water 

and not directly to sediment and 

because measured concentrations 

were not provided. In the 

absence of data, EPA may 

assume that hazard and risk to 

invertebrates exposed to boscalid 

residues in sediment are greater 

than those from exposure in the 

water column. It is 

recommended that the registrant 

conduct tests with three species 

(including freshwater and 

estuarine/marine) and to submit a 

protocol for review prior to test 

initiation.

Insect Pollinator Testing

850.3020 

Honey bee acute 

contact toxicity—

TGAI and TEP 

45405019 

48470202 

Acceptable 

Supplemental No

Nonguideline 

Honeybee acute 

oral toxicity 

study—TGAI and 

TEP 

45405019 

48470202

Acceptable 

Supplemental No
35 

Guideline Description—Test 

Substance

MRID or 

Acc. No. 

Study 

Classification 

Are data 

Needed for 

Risk 

Assessment? 

Comments 

(Justification and Assumptions 

EPA will Make in Absence of 

Data) 

Nonguideline Larval Toxicity 

Test—TGAI 49361801 Supplemental No

850.3030 

Honeybee toxicity 

of residues on 

foliage—TEP 

None N/A No

850.3040 

Field testing for 

pollinators – TGAI 

and TEP 

49009301 

49009303 

48470201 

Supplemental 

Supplemental 

Supplemental

No

This guideline number 

(850.3040) was used as a 

placeholder to recommend higher 

tier (semi-field) studies

evaluating effects of boscalid a.i. 

and Pristine® exposure, 

respectively, on honey bee brood 

development; one study with 

Pristine® (MRID 49009303) also 

examined queen cell 

development.

Nonguideline 

Determination of 

residues in royal 

jelly and pollen –

TEP (Pristine®, 

boscalid + 

pyraclostrobin) 

49009304 Supplemental No

The formulated product 

(Pristine®) was not applied while 

bees were actively foraging and 

there is uncertainty as to the 

extent that residues may have 

differed had bees been actively 

foraging. Control colonies were 

not treated with adjuvant; ideally, 

the controls should be treated in 

the same manner as the treatment 

groups minus the use of 

Pristine®.

Terrestrial Plant Testing 

850.4100 Seedling emergence 

(10 species)—TEP 47627401 Acceptable No Measured treatment rates were not reported.

850.4150 Vegetative vigor 

(10 species)—TEP 47627402 Supplemental 

Yes

(cabbage 

only)

Treatment rates were too high to 

establish definitive endpoints for 

the most sensitive dicot 

(cabbage). In the absence of 

data, EPA may conclude risk to 

listed and nonlisted species of 

dicot plants.

Aquatic Plant Testing

850.4400 

Aquatic plant 

growth, vascular 

plant 

—TGAI 

45405013 Acceptable No
36 

Guideline Description—Test 

Substance

MRID or 

Acc. No. 

Study 

Classification 

Are data 

Needed for 

Risk 

Assessment? 

Comments 

(Justification and Assumptions 

EPA will Make in Absence of 

Data) 

850.4500*

Aquatic Plant, 

freshwater green 

alga species—

TGAI 

45405017 Supplemental No

Classified as supplemental 

because study conditions were 

poorly described. New data are 

not recommended at this time 

because they are unlikely to 

impact the risk assessment

Aquatic Plant, 

freshwater diatom 

—TGAI 

45405014 Acceptable No

Aquatic Plant, 

marine diatom 

—TGAI 

45405016 Acceptable No

850.4550†

Aquatic Plant, 

cyanobacterium—

TGAI 

45405015 Supplemental No

Classified as supplemental 

because of uncertainty with 

measured concentrations. The 

EC50 and IC50 were greater than 

the highest concentration tested 

(i.e, > 4 mg/L nominal). New 

data are not recommended at this 

time because they are unlikely to 

impact the risk assessment. 

Other

Nonguideline 

14-day toxicity to 

soil-dwelling 

invertebrates 

(earthworm)

45405020 Supplemental No

Classified as a supplemental, 

nonguideline study; deficiencies 

included an insufficient 

acclimation period and the 

absence of measured 

concentrations and stability data. 

For earthworms, a 28-day study 

is generally preferred, though 

there is no active EPA guideline 

requirement for this.

TGAI = Technical Grade Active Ingredient 

TEP = typical end-use product 

* Algal toxicity tests are now under guideline OCSPP 850.4500 (formerly 850.5400) 

†

 Cyanobacterium tests are now under guideline 850.4550 (formerly 850.5400) 

12. References 

Allen-King, R. M., Grathwohl, P., & Ball, W. P. 2002. New modeling paradigms for the 

sorption of hydrophobic organic chemicals to heterogenous carbonaceous matter 

in soils, sediments, and rocks. Advances in Water Resources, 25, 985-1016. 

Elskus, A. 2012. Toxicity, Sublethal Effects, and Potential Modes of Action of Select 

Fungicides on Freshwater Fish and Invertebrates. Open-File Report 2012-2013. 

U.S. Department of the Interior. U.S. Geological Survey. Available at 
37 

http://pubs.usgs.gov/of/2012/1213/pdf/ofr2012-1213_report_508_rev092712.pdf

(Accessed August 8, 2014). 

FAO. 2000. Appendix 2. Parameters of pesticides that influence processes in the soil. In 

FAO Information Division Editorial Group (Ed.), Pesticide Disposal Series 8. 

Assessing Soil Contamination. A Reference Manual. Rome: Food & Agriculture 

Organization of the United Nations (FAO). Available at 

http://www.fao.org/DOCREP/003/X2570E/X2570E06.htm (Accessed July 10, 

2009). 

Fungicide Resistance Action Committee. 2012. FRAC code list fungicides sorted by 

mode of action including FRAC code numbering. Available at 

http://www.frac.info/frac/index.htm (Accessed August 23, 2012). 

Mathur, S. 2002.D285692. Secondary Product Chemistry Review of MP. D. B. 

3285692. October 31, 2002. Registration Division. Office of Pesticide Programs. 

United States Environmental Protection Agency. 

NAFTA. 2012. Guidance for Evaluating and Calculating Degradation Kinetics in 

Environmental Media. December 2012. NAFTA Technical Working Group on 

Pesticides. Available at 

http://www.epa.gov/oppfead1/international/naftatwg/guidance/degradationkin.pdf (Accessed April 11, 2014). 

Nelson, H., Bietlot, H., & Levy, A. 2003. BAS 510F in/on Various Plant and Animal 

Commodities. HED Metabolism Assessment Review Committee (MARC) Memo. 

D286786. January 9,2003. Health Effects Divison. Office of Pesticide Programs. 

United States Environmental Protection Agency. 

Reilly, T., Smalling, K., Orlando, J. L., & Kuivila, K. M. 2012. Occurrence of boscalid 

and other selected fungicides in surface water and groundwater in three targeted 

use areas in the United States. Chemosphere, 89, 228-234. 

Schumer, C., Mothiron, E., Appenzeller, B. M. R., Rizet, A., Wennig, R., & Millet, M. 

2010. Temporal variations of concentrations of currently used pesticides in the 

atmosphere of Strasbourg, France. Environmental Pollution, 158, 576-584. 

Smalling, K., & Orlando, J. L. 2011. United States Geological Survey. Occurrence of 

Pesticides in Surface Water and Sediments from Three Central Califorina Coastal 

Watersheds, 2008-09. Data Series 600. Available at Occurrence of Pesticides in 

Surface Water and Sediments from Three Central Califorina Coastal Watersheds, 

2008-09 (Accessed March 11, 2013). 

USEPA. 2003.D278387+. EFED Risk Assessment for Section 3 Registration of BAS 510 

F (Nicobifen). D. D278387, D278389, D278390, D278418. May 28, 2003. 

Environmental Fate and Effects Division. Office of Prevention, Pesticides, and 

Toxic Substances. U.S. Environmental Protection Agency. 

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of 

Pesticide Programs. Environmental Fate and Effects Division. Office of 

Pesticide Programs. U.S. Environmental Protection Agency. Available at 

http://www.epa.gov/espp/consultation/ecorisk-overview.pdf (Accessed June 19, 

2009). 

USEPA. 2006. Standardized Soil Mobility Classification Guidance. Memorandum From 

S. Bradbury to E. F. a. E. Division. April, 21, 2006. Environmnental Fate and 
38 

Effects Division. Office of Pesticide Programs. Office of Prevention, Pesticides, 

and Toxic Substances. United State Environmental Protection Agency. 

USEPA. 2008. Fate, Transport, and Transformation Guidelines. OPPTS 835.6100 

Terrestrial Field Dissipation. EPA 712-C-08-020. October 2008. Office of 

Prevention, Pesticides, and Toxic Substances. U.S. Environmental Protection 

Agency. Available at http://www.epa.gov/opptsfrs/publications/835_6100.pdf

(Accessed July 30, 2009). 

USEPA. 2009a. Estimation Program Interface (EPI) Suite: United States Environmental 

Protection Agency. Available at 

http://www.epa.gov/oppt/exposure/pubs/episuite.htm (Accessed August 24, 

2012). 

USEPA. 2009b. SAP Minutes No. 2009-01. A set of Scientific Issues Being Considered 

by the Environmental Protection Agency Regarding: Selected Issues Associated 

with the Risk Assessment Process for Pesticides with Persistent, Bioaccumulative, 

and Toxic Characteristics. October 28-31, 2008. January 29, 2009. FIFRA 

Scientific Advisory Panel. Office of Science Coordination and Policy. Available 

at http://www.epa.gov/scipoly/sap/meetings/2008/102808_mtg.htm (Accessed 

July 9, 2009). 

USEPA. 2010.D363523. Boscalid Section 3: Environmental Fate and Ecological Risk 

Assessment for the Proposed New Uses on Alfalfa and Citrus (Group 10). 

D363523. February 19, 2010. Environmental Fate and Effects Division. Office of 

Prevention, Pesticides, and Toxic Substances. U.S. Environmental Protection 

Agency. 

USEPA. 2010. Guidance for Reporting on the Environmental Fate and Transport of the 

Stressors of Concern in the Problem Formulation for Registration Review, 

Registration Review Risk Assessments, Listed Species Litigation Assessments, 

New Chemical Risk Assessments, and Other Relevant Risk Assessments. January 

25, 2010. Environmental Fate and Effects Division. Office of Chemical Safety 

and Pollution Prevention. U.S. Environmental Protection Agency. Available at 

http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endan

gered_species_reregistration_workgroup/esa_reporting_fate.htm (Accessed July 

5, 2012). 

USEPA. 2012a. Criteria Used by the PBT Profiler. September 4, 2012. Office of 

Chemical Safety and Pollution Prevention. United States Environmental 

Protection Agency. Available at http://www.pbtprofiler.net/criteria.asp (Accessed 

September 7, 2012). 

USEPA. 2012b. Environmental Chemistry Method Guidance. Memorandum From D. 

Brady to Environmental Fate and Effects Division. December 20, 2012. 

Environmental Fate and Effects Division. Office of Pesticide Programs. Office of 

Chemical Safety and Pollution Prevention. U.S. Environmental Protection 

Agency. 

USEPA. 2012c. Standard Operating Procedure for Using the NAFTA Guidance to 

Calculate Representative Half-life Values and Characterizing Pesticide 

Degradation. November 30, 2012. Environmental Fate and Effects Division. 

Office of Pesticide Programs. U.S. Environmental Protection Agency. Available 

at 
39 

http://www.epa.gov/oppefed1/ecorisk_ders/degradation_kinetics/NAFTA_Degrad

ation_Kinetics.htm (Accessed December 16, 2013). 

USEPA. 2013.D405817+. Environmental Fate and Ecological Risk Assessment for the 

Proposed New Uses of Boscalid for Various Agricultural Crops, Ornamentals, 

and Residential Gardens. D405817+. August 13, 2013. Environmental Fate and 

Effects Division. Office of Pesticide Programs. U.S. Environmental Protection 

Agency. 

USEPA. 2013.D409880. Tier I Drinking Water Exposure Assessment for the Section 3 

New Use of Boscalid on Various Agricultural Crops and Homeowner Uses. 

D409880. April 30, 2013. Environmental Fate and Effects Division. Office of 

Pesticide Programs. U.S. Environmental Protection Agency. 

USEPA. 2014a. BEAD Chemical Profile for Registration Review: Boscalid (128008). 

Memorandum From L. Yourman, J. Alsadeck & M. RAnville to M. Piansay. 

Biological and Economic Analysis Division. Office of Pesticide Programs. U.S. 

Environmental Protection Agency. 

USEPA. 2014b. Boscalid: Screening Level Usage Analysis. February 14, 2014. 

Biological and Economic Analysis Division. Office of Pesticide Programs. U.S. 

Environmental Protection Agency. 

USEPA. 2014c. Drinking Water and Ecological Risk Assessment in Support of the 

Boscalid Section 3 New Use on Stone Fruit Group 12-12, Tree Nut Group 14-12, 

Herb Subgroup Subgroup 19A, and Dill Seed. D416697+. August 2014. 

Environmental Fate and Effects Division. Office of Pesticide Programs. U.S. 

Environmental Protection Agency. 

USEPA. 2014d. Surface Water Concentration Calculator User Manual. USEPA/OPP 

734F14001. July 1, 2014. Environmental Fate and Effects Division. Office of 

Pesticide Programs. U.S. Environmental Protection Agency. Available at 

http://www.epa.gov/oppefed1/models/water/#swcc (Accessed August 11, 2014). 

Wharton, P. S. 2010. Fungicides - A practical approach to resistance management for 

potato diseases. Available at http://www.potatodiseases.org/pdf/FungicideResistance-Management.pdf (Accessed August 11, 2014). 
40 

Appendix A. Summary of registered products containing boscalid 

Registration 

# Name Status 

Percent 

Active 

Ingredient 

Active Ingredient(s) 

4-488 BONIDE FT09 Registered (16-May- 2013) 

5.622 boscalid 

0.5 lambda-Cyhalothrin 

3.06 Pyraclostrobin 

499-553 TC-308 

Conditionally 

Registered (20-Dec2011) 

1.75 Pyraclostrobin 

3.5 boscalid 

7969-196 EMERALD FUNGICIDE Registered (23-Jul- 2003) 70 boscalid 7969-197 ENDURA FUNGICIDE Registered (23-Jul- 2003) 70 boscalid 7969-198 BOSCALID TECHNICAL Registered (23-Jul- 2003) 99 boscalid 7969-199 PRISTINE FUNGICIDE Registered (23-Jul- 2003) 25.2 boscalid 12.8 Pyraclostrobin 7969-248 BAS 516 ST SEED TREATMENT FUNGICIDE Conditionally Registered (30-May- 2007) 25.2 boscalid 12.8 Pyraclostrobin 7969-251 PAGEANT INTRINSIC BRAND FUNGICIDE Conditionally Registered (28-Feb- 2008) 25.2 boscalid 12.8 Pyraclostrobin 7969-255 HONOR INTRINSIC BRAND FUNGICIDE Conditionally Registered (03-Jul- 2007) 11.2 boscalid 16.8 Pyraclostrobin 
41 

7969-274 CORONET FUNGICIDE SEED TREATMENT Conditionally Registered (22-May- 2008) 18 boscalid 9 Pyraclostrobin 7969-348 Encartis Fungicide Registered (01-Nov- 2012) 54.14 Chlorothalonil 2.2 boscalid 7969-353 Homeowner Garden Spray Fungicide Registered (20-Nov- 2013) 18 boscalid 9 Pyraclostrobin 

OR070001 ENDURA FUNGICIDE Under Review (02- May-2007) 70 boscalid 

SD090006 PRISTINE FUNGICIDE Registered (22-Jan- 2010) 25.2 boscalid 12.8 Pyraclostrobin SD090007 EMERALD FUNGICIDE Registered (22-Jan- 2010) 70 boscalid 
42 

Appendix B. Submitted Environmental Fate Studies 

MRID Citation Reference 

63-0 Reports of Multiple phys/chem Characteristics 

45404803 Kastel, R. (2001) Physical and Chemical Properties of PS 300 355 (BAS 510 F): Final Report: Lab Project 

Number: PCF 01895: Unpublished study prepared by BASF Aktiengesellschaft. 15 p. (OPPTS 830.6302, 

830.6303, 830.6304, 830.6313, 830.7000, 830.7200, 830.7300) 

45438501 Sears, L. (2001) BAS 510 F Active Ingredient: Comprehensive Data Summary: Lab Project Number: M11: 2001/5001183: 1998/10640. Unpublished study prepared by BASF Canada. 522 p. 

45438502 Sears, L. (2001) BAS 510 02F Active Ingredient: BAS 510F: Comprehensive Data Summary End Use 

Product: Lab Project Number: M-111: 2001/5001185. Unpublished study prepared by BASF Canada. 160 

p. 

45438503 Sears, L. (2001) BAS 510 02F Active Ingredient: BAS 510F Pyraclostrobin: Comprehensive Data 

Summary End Use Product: Lab Project Number: M-111: 2001/5001186. Unpublished study prepared by 

BASF Canada. 82 p. 

63-3 Physical State 

45404802 Daum, A. (2001) Determination of the Melting Point and the Appearance of BAS 510 F: Final Report: Lab 

Project Number: PCP05375: 1999/10991. Unpublished study prepared by BASF Aktiengesellschaft. 9 p. 

(OPPTS 830.7200) 

45405311 Yacoub, R. (2000) BAS 516 02F: Determination of Physical State, Bulk Density, and pH: Lab Project 

Number: 48146: 2000/5255. Unpublished study prepared by BASF Corporation. 10 p. (OPPTS 830.6303, 

830.7000, 830.7300) 

45405321 Yacoub, R. (2000) BAS 510 02F: Determination of Physical State, Bulk Density, and pH: Final Report: 

Lab Project Number: 44129: 2000/5211. Unpublished study prepared by BASF Corporation. 10 p. (OPPTS 

830.6303, 830.7000, 830.7300) 

47285603 Horsler, C. (2007) Physical and Chemical Properties of Pyraclostrobin/Boscalid 100/200 g/L FS, BAS 516 

09 F: Storage Stability for Up to 8 Weeks at 40 Degrees Celsius in Commercial Packs. Project Number: 

MX/06/034/1, 2006/1024716. Unpublished study prepared by Battelle UK Ltd. 22 p. 

48311301 Reed, L. (2010) Physical and Chemical Characteristics of TC-308 [BAS 516 HA F]. Project Number: 

09/0529, 2516. Unpublished study prepared by Whitmire Micro-Gen Research Laboratories, Inc. 11 p. 

63-5 Melting Point 

45404802 Daum, A. (2001) Determination of the Melting Point and the Appearance of BAS 510 F: Final Report: Lab 

Project Number: PCP05375: 1999/10991. Unpublished study prepared by BASF Aktiengesellschaft. 9 p. 

(OPPTS 830.7200) 

63-7 Density 

45404806 Kastel, R. (1999) Physical Properties of 300 355 (PAI): Lab Project Number: PCF 01962: 199/10203. 

Unpublished study prepared by BASF Aktiengesellschaft. 13 p. (OPPTS 830.7950) 

45405311 Yacoub, R. (2000) BAS 516 02F: Determination of Physical State, Bulk Density, and pH: Lab Project 

Number: 48146: 2000/5255. Unpublished study prepared by BASF Corporation. 10 p. (OPPTS 830.6303, 

830.7000, 830.7300) 

45405321 Yacoub, R. (2000) BAS 510 02F: Determination of Physical State, Bulk Density, and pH: Final Report: 

Lab Project Number: 44129: 2000/5211. Unpublished study prepared by BASF Corporation. 10 p. (OPPTS 

830.6303, 830.7000, 830.7300) 

47285603 Horsler, C. (2007) Physical and Chemical Properties of Pyraclostrobin/Boscalid 100/200 g/L FS, BAS 516 

09 F: Storage Stability for Up to 8 Weeks at 40 Degrees Celsius in Commercial Packs. Project Number: 

MX/06/034/1, 2006/1024716. Unpublished study prepared by Battelle UK Ltd. 22 p. 
43 

48311301 Reed, L. (2010) Physical and Chemical Characteristics of TC-308 [BAS 516 HA F]. Project Number: 

09/0529, 2516. Unpublished study prepared by Whitmire Micro-Gen Research Laboratories, Inc. 11 p. 

63-8 Solubility 

45404804 Daum, A. (1998) Determination of the Solubility of BAS 510 F in Water at 20 Degrees C by Column 

Elution Method and by HPLC: Final Report: Lab Project Number: PCP04888: 1998/10961. Unpublished 

study prepared by BASF Aktiengesellschaft. 16 p. (OPPTS 830.7840) 

45404805 Daum, A. (1998) Determination of the Solubility of BAS 510 F Pure Active Ingredient (PAI) in Organic 

Solvents at 20 Degrees Celsius: Final Report: Lab Project Number: PCP048676: 1998/10953. Unpublished 

study prepared by BASF Aktiengesellschaft. 13 p. (OPPTS 830.7840) 

63-9 Vapor Pressure 

45404806 Kastel, R. (1999) Physical Properties of 300 355 (PAI): Lab Project Number: PCF 01962: 199/10203. 

Unpublished study prepared by BASF Aktiengesellschaft. 13 p. (OPPTS 830.7950) 

63-10 Dissociation Constant 

45404807 Daum, A. (1998) Determination of the pKa of BAS 510.F in Water at 20 Degrees Celsius: Lab Project 

Number: PCP04896: 1998/10967. Unpublished study prepared by BASF Aktiengesellschaft. 13 p. (OPPTS 

830.7370) 

63-11 Oct/Water partition Coef. 

45404809 Daum, A. (1998) Determination of the Octanol/Water-Partition Coefficient of BAS 510 F by HPLC: Final 

Report: Lab Project Number: PCP05017: 1998/11082. Unpublished study prepared by BASF 

Aktiengesellschaft. 17 p. (OPPTS 830.7570) 

132-1 Dissipation of Dislodgeable Foliar & Soil Residues 

45405301 Haughey, D.; Jones, J. (2001) BAS 510 UCF Turf Transferable Residue Study: Final Report: Lab Project 

Number: 2001/5001157. Unpublished study prepared by BASF Agro Research. 54 p. (OPPTS 875.2100) 

45405302 Haughey, D.; Jones, J. (2001) BAS 510 UCF Dislodgeable Foliar Residue Study in Tomatoes: Final 

Report: Lab Project Number: 64150: 2001/5000837. Unpublished study prepared by BASF Agro Research 

and Crop Management Strategies, Inc. 61 p. (OPPTS 875.2100) 

45405303 Haughey, D.; Jones, J. (2001) BAS 510 UCF Dislodgeable Foliar Residue Study in Grapes: Final Report: 

Lab Project Number: 2001/5000839: 64078. Unpublished study prepared by BASF Agro Research. 73 p. 

(OPPTS 875.2100) 

45405304 Haughey, D.; Jones, J. (2001) BAS 510 UCF Dislodgeable Foliar Residue Study in Peaches: Final Report: 

Lab Project Number: 63916: 1999/5191. Unpublished study prepared by BASF Agro Research and 

Research for Hire. 72 p. (OPPTS 875.2100) 

45405305 Haughey, D.; Jones, J. (2001) BAS 510 UCF Dislodgeable Foliar Residue Study in Strawberries: Final 

Report: Lab Project Number: 1999/5193: 63914. Unpublished study prepared by BASF Agro Research and 

Research for Hire. 72 p. (OPPTS 875.2100) 

45672102 Haughey, D. (2002) Response to PMRA Request for Clarification for: BAS 510 02F Crop Fungicide and 

BAS 510 02F Turf Fungicide: Lab Project Number: 2002/5002770: 64150: 200281. Unpublished study 

prepared by BASF Agro Research. 271 p. (OPPTS 875.2100) 

161-1 Hydrolysis 

45405205 von Gotz, N. (1999) Hydrolysis of BAS 510 F: Lab Project Number: 41874: 1999/11285. Unpublished 

study prepared by BASF Aktiengesellschaft. 21 p. 

161-2 Photodegradation-water 

45405206 von Gotz, N. (1999) Aqueous Photolysis of BAS 510 F: Final Report: Lab Project Number: 41875: 

1999/111804. Unpublished study prepared by BASF Aktiengesellschaft. 28 p. 

161-3 Photodegradation-soil 

45405207 von Goetz, N. (2000) Soil Photolysis of BAS 510 F: Final Report: Lab Project Number: 41859: 

2000/1014989. Unpublished study prepared by BASF Aktiengesellschaft. 37 p. 

162-1 Aerobic soil metabolism 
44 

45405208 Stephan, A. (1999) Metabolism of BAS 510F (Carbon 14-Diphenyl and Carbon 14-Pyridin) in Soil Under 

Aerobic Conditions: Lab Project Number: 42381: 1999/11807. Unpublished study prepared by BASF 

Aktiengesellschaft. 105 p. 

45405209 Ebert, D.; Harder, U. (2000) Degradation of (Carbon 14)-Chloronicotinic Acid in Soil under Aerobic 

Conditions: Lab Project Number: 54518: 2000/1013280. Unpublished study prepared by BASF 

Aktiengesellschaft. 31 p. 

45405210 Paulick, R. (2001) Aerobic Soil Metabolism of (Carbon 14)-BAS 510 F: Lab Project Number: 64052: 

2001/5001022. Unpublished study prepared by BASF Corporation. 63 p. 

45643802 Paulick, R. (2002) Aerobic Soil Metabolism of (Carbon 14)-BAS 510 F: Lab Project Number: 

2002/5002772: 64052. Unpublished study prepared by BASF Agro Research. 93 p. 

162-2 Anaerobic soil metabolism 

45405211 Staudenmaier, H. (2000) Anaerobic Metabolism of BAS 510 F in Soil (Carbon 14-Pyridine Label): Final 

Report: Lab Project Number: 41858: 2000/1014990. Unpublished study prepared by BASF 

Aktiengesellschaft. 50 p. 

45405212 Staudenmaier, H.; Schafer, C. (2000) Anaerobic Metabolism of BAS 510 F in Soil (Carbon 14-Diphenyl 

Label): Final Report: Lab Project Number: 42382: 2000/1014986. Unpublished study prepared by BASF 

Aktiengesellschaft. 57 p. 

162-3 Anaerobic aquatic metab. 

45405213 Paulick, R.; Baucom, M. (2001) Anaerobic Aquatic Metabolism of (Carbon 14)-BAS 510 F: Lab Project 

Number: 42385: 2001/5001021. Unpublished study prepared by BASF Corporation and AgVise 

Laboratories. 80 p. 

162-4 Aerobic aquatic metab. 

45405214 Ebert, D. (2000) Degradation of BAS 510 F in Aerobic Aquatic Environment: Final Report: Lab Project 

Number: 2000/1000135: 41856. Unpublished study prepared by BASF Aktiengesellschaft. 85 p. 

163-1 Leach/adsorp/desorption 

45405216 Seher, A. (1998) BAS 510 F-Soil Adsorption / Desorption Study of 300 355: Lab Project Number: 

1998/10513: PI970023. Unpublished study prepared by BASF Aktiengesellschaft. 64 p. 

45405217 Seher, A. (2001) Adsorption/Desorption-Study of 107371 (M510f47) on 3 US Soils: Final Report: Lab 

Project Number: 2001/1000967: 9100031. Unpublished study prepared by BASF Aktiengesellschaft. 39 p. 

164-1 Terrestrial field dissipation 

45405218 Oliver, G.; Saha, M.; Jackson, S. (2001) 1999 Field Dissipation of BAS 510..F in Orchard/Vineyard Use 

Patterns: Lab Project Number: 47616: 2000/5277. Unpublished study prepared by AgriScope, LLC., 

Research For Hire and ACDS Research, Inc. 400 p. 

45405219 Jackson, S.; Saha, M.; McDonell, J. et al. (2001) 1999 Field Dissipation of BAS 510..F in Turf Use 

Patterns: Lab Project Number: 46626: 2001/5000833. Unpublished study prepared by Crop Management 

Strategies, Inc., Alvey Ag Research, and South Texas Ag Research. 559 p. 

45405220 Jackson, S.; Saha, M.; McDonell, J. (2001) 1999 Field Dissipation of BAS..F in Raw Crop Use Patterns: 

Lab Project Number: 46699: 2001/5000936. Unpublished study prepared by Research For Hire, Smith 

Biological Services, and Research Options, Inc. 399 p. 

45405221 Jackson, S.; Saha, M.; McDonell, J. (2001) 1999 Field Dissipation of BAS 510..F in Terrestrial Use 

Patterns: Lab Project Number: 46767: 2001/5000937: ADPEN-903-2K-B46767-001. Unpublished study 

prepared by BASF Agro Research, Northern Plaines Ag Research, and Agrisan, Inc. 243 p. 

45405222 Jackson, S.; Saha, M.; McDonell, J. (2001) 1999 Field Dissipation of BAS 510..F in Terrestrial Use 

Patterns for Canada: Lab Project Number: 58847: 2001/5000938: ADPEN-903-2K-D58647-001. 

Unpublished study prepared by BASF Agro Research, Vaughn Agricultural Research Services, and ICMS, 

Inc. 285 p. 

45405223 Gooding, R. (2001) Freezer Storage Stability Study of BAS 510 F, 2-Chloronicotinic Acid, and 2-

Hydroxy-N-(4'-Chlorobiphenyl-2-yl)Nicotinamide in Soil Using LC-MS/MS: Lab Project Number: 46656: 

2001/5000904. Unpublished study prepared by BASF Corporation. 62 p. 
45 

45405224 Stephan, A. (2000) Storage Stability of BAS 510 F in Soil: Final Report: Lab Project Number: 41865: 

2000/1000136. Unpublished study prepared by BASF Aktiengesellschaft. 43 p. 

45405225 Saha, M. (2001) Validation of BASF Method No. D0004 and D0004/1: The Determination of Residues of 

BAS 510 F and its Metabolites in Soil Using LC-MS/MS: Lab Project Number: 46625: 2001/5000881. 

Unpublished study prepared by BASF Corporation. 137 p. 

45405226 Saha, M.; South, N. (2001) Independent Method Validation of BASF Analytical Method D0004/1: 

Amended Final Report: Lab Project Number: AG000097: 43695: 2001/5000882. Unpublished study 

prepared by Battelle Memorial Institute. 41 p. 

45405227 Saha, M. (2001) Analytical Method CP-No. 327: The Determination of BAS 510 F in Water: Lab Project 

Number: 2001/5001127. Unpublished study prepared by Wildlife International, Ltd. 20 p. 

165-1 Confined rotational crop 

45405204 Hamm, R.; Veit, P. (2001) Confined Rotational Crop Study with (Carbon 14)-BAS 510 F: Lab Project 

Number: 41838: 2000/1014862: Unpublished study prepared by BASF Aktiengesellschaft. 257 p. (OPPTS 

860.1850) 

165-2 Field rotational crop 

45405203 Haughey, D.; Abdel-Baky, S. (2001) Limited Rotational Crop Study for the Use of BAS 510 F: Final 

Report: Lab Project Number: 46697: 2001/5000966. Unpublished study prepared by BASF Corporation. 88 

p. (OPPTS 860.1900) 

45623409 Versoi, P.; Abdel-Baky, S. (2002) Magnitude of the Residue of BAS 510 F in Peas and Beans Planted As 

Rotational Crops and of BAS 500 F In Peas and Beans When Applied as a Foliar Spray: Final Report: Lab 

Project Number: 130001: 2001/5003311: 66690. Unpublished study prepared by BASF Agro Research. 

118 p. (OPPTS 860.1900 and 860.1500)

45623411 Jordan, J. (2002) Field Rotational Study for BAS 510 F on Grasses, Alfalfa and Clover As Livestock Feed 

Crops: Final Report: Lab Project Number: 2002/5002063: 66692: F-96/1. Unpublished study prepared by 

BASF Agro Research. 105 p. (OPPTS 860.1900) 

45623412 Jordan, J. (2002) Cereal Grains and Soybean Field Rotational Crop Study for BAS 510 F: Final Report: 

Lab Project Number: 2002/5001341: 64382: RCN 2001129. Unpublished study prepared by BASF Agro 

Research. 231 p. (OPPTS 860.1900) 

45623413 Jordan, J. (2002) Cotton Field Rotational Crop Study for BAS 510 F: Final Report: Lab Project Number: 

2002/5002425: 66690: BAS 510 UCF. Unpublished study prepared by BASF Agro Research. 51 p. 

(OPPTS 860.1900) 

165-4 Bioaccumulation in fish 

45405007 Chapelo, S.; Caley, C. (2000) Bioaccumulation and Metabolism of (Carbon 14) BAS 510 Rainbow Trout: 

Final Report: Lab Project Number: 18219: 2000/1017222: 394178. Unpublished study prepared by 

Inveresk Research. 176 p. 

171-4B Residue Analytical Methods 

45405027 Jones, J. (2001) Method for Determination of BAS 500 F, BF 500-3, and BAS 510 F Residues in Plant 

Matrices Using LC/MS/MS: Final Report: Lab Project Number: 64692: 2001/5001020: D9908. 

Unpublished study prepared by BASF Agro Research. 79 p. (OPPTS 860.1340) 

45405028 Jordan, J. (2001) Independent Method Validation of BASF Analytical Method D0008 Entitled "Method for 

Determining BAS 510 F in Plant and Turf Cloth Matrices Using GC/MS and Dislodgeable Foliar Sample 

Using HPLC/UV": Lab Project Number: 2001/5000880: 64954: D0008. Unpublished study prepared by 

BASF Corporation. 61 p. (OPPTS 860.1340)

45405101 Adbel-Baky, S.; Jones, J. (2001) Validation of BASF Analytical Method D0008, Method for Determining 

BAS 510 F in Plant and Turf Cloth Matrices Using GC/MS and Dislodgeable Foliar Samples Using 

HPLC/UV: Final Report: Lab Project Number: 64276: 2001/5000977: D0008. Unpublished study prepared 

by BASF Agro Research. 97 p. (OPPTS 860.1340)
46 

45405103 Class, T. (2001) Assessment and Validation of the Adapted Multi-Residue Method DFG S19 

Determination of BAS 510 F and its Metabolite M510F01 in Animal Matrices: Final Report: Lab Project 

Number: P/B 453 G: 2000/1017227: DFG S19. Unpublished study prepared by PTRL Europe. 88 p. 

(OPPTS 860.1340) 

45405105 Fabian, E. (2001) The Validation of BASF Method 476/0: The Determination of BAS F Residues (as 

M510F53) in Liver and Milk by Microwave Treatment: Final Report: Lab Project Number: 96997: 476/0: 

2000/1017224. Unpublished study prepared by BASF Aktiengesellschaft. 42 p. (OPPTS 860.1340) 

45405106 Grosshans, F. (2001) The Validation of BASF Method 471/0: The Determination of BAS 510F and the 

Metabolite M510F01 in Animal Matrices: Final Report: Lab Project Number: 42392: 471/0: 

2000/1017223. Unpublished study prepared by BASF Aktiengesellschaft. 74 p. (OPPTS 860.1340) 

45405107 Fomenko, J. (2001) PAM I Multiresidue Testing for BAS 510 F and its Hydroxy Metabolite (M 510 F01): 

Lab Project Number: A054.006: 2001/5000875: 46647. Unpublished study prepared by Maxim 

Technologies, Inc. 89 p. (860.1360) 

171-4C Magnitude of the Residue [by commodity] 

45405102 Kampke-Thiel, K. (2001) Independent Laboratory Validation of the Adapted Multi-Residue Method DFG 

S19 for the Determination of BAS 510 F and its Metabolite M510F01 in Animal Matrices: Final Report: 

Lab Project Number: 42397: 2000/1017226: P453G. Unpublished study prepared by BASF 

Aktiengesellschaft. 127 p. (OPPTS 860.1340)

45405108 Grosshans, F. (2001) Investigation of the Stability of Residues of BAS 510 F and MF510F01 in Sample 

Material of Animal Origin Under Usual Storage Conditions: Final Report: Lab Project Number: 42403: 

2000/1017229. Unpublished study prepared by BASF Aktiengesellschaft. 47 p. (OPPTS 860.1380) 

45405109 Funk, H.; Mackenroth, C. (2001) Investigation of the Stability of Residues of BAS 510 F in Matrices under 

Normal Storage Conditions: Lab Project Number: 41851: 200/1014855. Unpublished study prepared by 

BASF Aktiengesellschaft. 33 p. (OPPTS 860.1380) 

45405111 Haughey, D.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Almonds: Final Report: 

Lab Project Number: 63902: 2000/5226: 99135. Unpublished study prepared by BASF Corporation. 53 p. 

(OPPTS 860.1500) 

45405112 Versoi, P.; Adbel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Dry Bulb and Green Onions: 

Final Report: Lab Project Number: 2000/5207: 63894: 99171 (PA/1). Unpublished study prepared by 

BASF Corporation. 55 p. (OPPTS 860.1500) 

45405113 Versoi, P.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Carrots: Final Report: Lab 

Project Number: 63896: 2000/5208: 99180 (FL/3). Unpublished study prepared by BASF Corporation. 50 

p. (OPPTS 860.1500) 

45405114 Haughey, D.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Strawberries: Final Report: 

Lab Project Number: 63910: 2000/5227: 99157 (PA/1). Unpublished study prepared by BASF Corporation. 

50 p. (OPPTS 860.1500) 

45405115 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Pistachios: Final Report: 

Lab Project Number: 63898: 2000/5229: 99337 (CA/10). Unpublished study prepared by BASF 

Corporation. 42 p. (OPPTS 860.1500) 

45405116 Versoi, P.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Canola: Final Report: Lab 

Project Number: 58645: 2001/5000048: 2000110 (ND/5). Unpublished study prepared by BASF Agro 

Research. 69 p. (OPPTS 860.1500) 

45405117 Haughey, D.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Grapes: Final Report: Lab 

Project Number: 63892: 2000/5228: 2000110 (ND/5). Unpublished study prepared by BASF Corporation. 

56 p. (OPPTS 860.1500) 

45405118 Versoi, P.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Red Raspberries and 

Highbush Blueberries: Final Report: Lab Project Number: 2000/5195: 63912: 99277/NY/1. Unpublished 

study prepared by BASF Corporation. 53 p. (OPPTS 860.1500) 
47 

45405119 Haughey, W.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Tomatoes: Final Report: 

Lab Project Number: 46786: 2001/5000832: 2000204. Unpublished study prepared by BASF Agro 

Research. 54 p. (OPPTS 860.1500) 

45405120 Haughey, D.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Dry, Snap, and Lima 

Beans: Final Report: Lab Project Number: 2001/5000905: 46764: 2000177. Unpublished study prepared by 

BASF Agro Research. 89 p. (860.1500) 

45405121 Wofford, T.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Stone Fruit: Amended Final 

Report: Lab Project Number: 63904: 2001/5000831: 99101. Unpublished study prepared by BASF 

Corporation. 80 p. (OPPTS 860.1500) 

45405122 Wofford, J.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Peanut Raw Agricultural 

Commodities and Peanut Process Fractions: Final Report: Lab Project Number: 64106: 2001/5000870: 

2000148. Unpublished study prepared by BASF Agro Research. 116 p. (OPPTS 860.1500. 860.1520) 

45405123 Wofford, J.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Potato: Final Report: Lab 

Project Number: 64126: 2001/5000879: 2000161. Unpublished study prepared by BASF Agro Research. 

63 p. (OPPTS 860.1520, 860.1500) 

45405124 Versoi, P.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Canola Seed Processed 

Fractions: Amended Final Report: Lab Project Number: 58646: 2001/5001064: 2000111. Unpublished 

study prepared by BASF Agro Research. 98 p. (OPPTS 860.1520) 

45405125 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Grape Processed Fractions: 

Final Report: Lab Project Number: 46650: 2001/500065: MG6176. Unpublished study prepared by BASF 

Corporation. 75 p. (OPPTS 860.1520) 

45405126 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Tomato Processed 

Fractions: Final Report: Lab Project Number: 46788: 2001/5000967: 2000210. Unpublished study prepared 

by BASF Corporation. 133 p. (OPPTS 860.1520) 

45405127 Versoi, P.; Abdel-Baky, S. (2000) The Magnitude of BAS 510 F Residues in Bell and Chili Peppers: Final 

Report: Lab Project Number: 63918: 2000/5209: 99345 (GA/2). Unpublished study prepared by BASF 

Corporation. 57 p. (OPPTS 860.1500) 

45405128 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Head and Leaf Lettuce: 

Final Report: Lab Project Number: 64114: 2001/5000051: 2000132. Unpublished study prepared by BASF 

Agro Research. 71 p. (OPPTS 860.1500) 

45405201 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Pecans: Final Report: Lab 

Project Number: 63900: 2000/5230. Unpublished study prepared by BASF Corporation. 47 p. (OPPTS 

860.1500) 

45405202 Wofford, J.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Plum Processed Fractions: 

Final Report: Lab Project Number: 63906: 2000/5275. Unpublished study prepared by BASF Corporation. 

70 p. (OPPTS 860.1520) 

45623401 Wofford, J.; Abdel-Baky, S. (2002) The Magnitude of BAS 510 F Residues in Cabbage: Final Report: Lab 

Project Number: 66704: 2001/5002617: F-96/1. Unpublished study prepared by BASF Agro Research. 51 

p. (OPPTS 860.1500) 

45623402 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Radishes: Final Report: 

Lab Project Number: 2001/5002572: 6694: 2001/5000848. Unpublished study prepared by BASF Agro 

Research. 50 p. (OPPTS 860.1500) 

45623403 Haughey, D.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F Residues in Cucurbits: Final Report: 

Lab Project Number: 2001/5002593: 66698: BAS 510 UCF. Unpublished study prepared by BASF Agro 

Research. 51 p. (OPPTS 860.1500) 

45623404 Wofford, J.; Abdel-Baky, S. (2002) The Magnitude of BAS 510 F Residues in Broccoli: Final Report: Lab 

Project Number: 2001/5002616: 66702: FR0108. Unpublished study prepared by BASF Agro Research. 43 

p. (OPPTS 860.1500) 
48 

45623405 Haughey, D.; Abdel-Baky, S. (2002) Magnitude of BAS 510 F and BAS 500 F Residues in Dry and 

Succulent Peas: Final Report: Lab Project Number: 2001/5003246: 66696: F200112. Unpublished study 

prepared by BASF Agro Research. 95 p. (OPPTS 860.1500) 

45623406 Wofford, J.; Abdel-Baky, S. (2002) Magnitude of BAS 510 F and BAS 500 F Residues in Mustard Greens-

-2001 Field Study: Final Report: Lab Project Number: 2001/5003339: 67080: CF-A 587. Unpublished 

study prepared by BASF Agro Research. 68 p. (OPPTS 860.1500) 

45623407 Versoi, P.; Abdel-Baky, S. (2002) The Magnitude of BAS 510 F and BAS 500 F Residues in Sunflower 

and Sunflower Processed Fractions: Final Report: Lab Project Number: 2001/5002552: 66710: RCN 

2001289. Unpublished study prepared by BASF Agro Research. 113 p. (OPPTS 860.1500 and 860.1520) 

45623408 Versoi, P.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F and BAS 500 F Residues in Mint and 

Mint Processed Fractions: Final Report: Lab Project Number: 66700: 2001/5002467: F200107. 

Unpublished study prepared by BASF Agro Research. 95 p. (OPPTS 860.1500 and 860.1520) 

45623409 Versoi, P.; Abdel-Baky, S. (2002) Magnitude of the Residue of BAS 510 F in Peas and Beans Planted As 

Rotational Crops and of BAS 500 F In Peas and Beans When Applied as a Foliar Spray: Final Report: Lab 

Project Number: 130001: 2001/5003311: 66690. Unpublished study prepared by BASF Agro Research. 

118 p. (OPPTS 860.1900 and 860.1500)

45623410 Versoi, P.; Abdel-Baky, S. (2001) The Magnitude of BAS 510 F and BAS 500 F Residues in Soybean 

Processed Fractions: Final Report: Lab Project Number: 2001/5002529: 66714: RCN 2001214. 

Unpublished study prepared by BASF Agro Research. 108 p. (OPPTS 860.1520) 

45623412 Jordan, J. (2002) Cereal Grains and Soybean Field Rotational Crop Study for BAS 510 F: Final Report: 

Lab Project Number: 2002/5001341: 64382: RCN 2001129. Unpublished study prepared by BASF Agro 

Research. 231 p. (OPPTS 860.1900) 

45623413 Jordan, J. (2002) Cotton Field Rotational Crop Study for BAS 510 F: Final Report: Lab Project Number: 

2002/5002425: 66690: BAS 510 UCF. Unpublished study prepared by BASF Agro Research. 51 p. 

(OPPTS 860.1900) 

45643801 Stewart, J. (2002) A Meat and Egg Magnitude of the Residue Study with BAS 510 F in Laying Hens: Final 

Report: Lab Project Number: 2002/5002466: 130019. Unpublished study prepared by BASF Agro 

Research. 202 p. (OPPTS 860.1480) 

45903601 Jordan, J. (2002) Magnitude of BAS 500 02 F and BAS 510 02 F Residues in Citrus: Final Report: Lab 

Project Number: 2002/5002446: 64978: 2001339(FL). Unpublished study prepared by BASF Agro 

Research. 129 p. (OPPTS 860.1500) 

45903602 Leonard, R. (2003) Magnitude of BAS 500 F and BAS 510 F Residues in Soybean: Final Report: Lab 

Project Number: 2002/5004272: 140578: 2002191(GA). Unpublished study prepared by BASF Agro 

Research. 157 p. (OPPTS 860.1500) 

860.1340 Residue analytical method 

46351401 Grosshans, F. (2001) The Validation of BASF Method 471/0: The Determination of BAS 510F and the 

Metabolite M510F01 In Animal Matrices: Amended Final Report. Project Number: 42392, 2004/5000681, 

471/0. Unpublished study prepared by BASF Ag Research Station (Basf Aktieng). 92 p. 

46351402 Fabian, E. (2001) The Validation of BASF Method 476/0: The Determination of BAS 510 F Residues (as 

M510F53) in Liver and Milk by Microwave Treatment: Amended Final Report. Project Number: 96997, 

2004/5000682, 476/0. Unpublished study prepared by BASF Ag Research Station (Basf Aktieng). 61 p. 

46351403 Class, T. (2001) Assessment and Validation of the Adapted Multi-Residue Method DFG S19 

Determination of BAS 510 F and its Metabolite M510F01 in Animal Matrices: Amended Final Report. 

Project Number: P/B/453/G, 2004/5000683, DFG/S19. Unpublished study prepared by BASF Ag Research 

Station (Basf Aktieng). 90 p.

46351405 Sasturain, J. (2000) Technical Procedure: Method for the Determination of BAS 480 F, BAS 490 F, BAS 

500 F and BAS 510 F in Plant Matrices: Final Report. Project Number: 445/0, 2000/1014864. Unpublished 

study prepared by BASF Ag Research Station (Basf Aktieng). 16 p. 
49 

47020701 Willard, T. (2006) Magnitude of the Residue of Pyraclostrobin and Boscalidin Cotton Raw Agricultural 

Commodities Resulting from Seed Treatment with BAS 500 UKF and BAS 510 04F: Final Report. Project 

Number: 2006/7007191, AA030704. Unpublished study prepared by BASF Agro Research and American 

Agricultural Services Inc. 151 p. 

860.1380 Storage stability data 

46351404 Funk, H.; Mackenroth, C. (2001) Investigation of the Stability of Residues of BAS 510 F in Plant Matrices 

Under Normal Storage Conditions. Project Number: 41851, 2001/1015028. Unpublished study prepared by 

BASF Ag Research Station (Basf Aktieng). 46 p. 

860.1900 Field accumulation in rotational crops 

46210606 Leonard, R. (2004) Sugar Beet, Garden Beet and Turnip Field Rotational Crop Study for BAS 510 02 F 

Residues: Final Report. Project Number: 130727, 2002/5004273, F/96/1. Unpublished study prepared by 

BASF Agro Research. 74 p. 

 Non-Guideline Study 

45405215 Fent, G. (2001) Degradation and Distribution of BAS 510 F in a Water-Sediment System Under Outdoor 

Conditions: Final Report: Lab Project Number: 2000/1017038: BAS37. Unpublished study prepared by 

BASF Aktiengesellschaft. 42 p. 

 
50 

Appendix C. Submitted Ecological Effects Studies 

72-1 Acute Toxicity to Freshwater Fish 

MRID Citation Reference 

 

48600214 Salinas, E. (2011) BAS 640 00 F - Acute Toxicity Study in the Fathead Minnow 

(Pimephales promelas). Project Number: 2011/1173957/OCR, 381191, 19F0047/10E129. 

Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 

45p.

141-1 Honey bee acute contact 

MRID Citation Reference 

 

48470201 Noe, J.; Lueckmann, J. (2010) Assessment of Potential Side-Effects of Pristine (BAS 516 

04 F) on the Honeybee (Apis mellifera L.) in a Bee Brood Study under Semi-Field 

Conditions in Germany 2009. Project Number: 2010/1007154, 373826. Unpublished study 

prepared by BASF SE Aktiengesellschaft. 82 p.

850.1075 Fish acute toxicity test, freshwater and marine 

MRID Citation Reference 

 

48600214 Salinas, E. (2011) BAS 640 00 F - Acute Toxicity Study in the Fathead Minnow 

(Pimephales promelas). Project Number: 2011/1173957/OCR, 381191, 19F0047/10E129. 

Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 

45p.

850.1300 Daphnid chronic toxicity test 

MRID Citation Reference 

 

46351406 Jatzek, J. (2004) BAS 510 F: Determination of the Chronic Effect on the Reproduction of 

the Water Flea Daphnia magna Straus: Final Report. Project Number: 51E0618/003004, 

2004/7007516, 2004/1015009. Unpublished study prepared by BASF Aktiengesellschaft. 

42 p.
51 

850.3020 Honey bee acute contact toxicity 

MRID Citation Reference 

 

48470201 Noe, J.; Lueckmann, J. (2010) Assessment of Potential Side-Effects of Pristine (BAS 516 

04 F) on the Honeybee (Apis mellifera L.) in a Bee Brood Study under Semi-Field 

Conditions in Germany 2009. Project Number: 2010/1007154, 373826. Unpublished study 

prepared by BASF SE Aktiengesellschaft. 82 p.

48470202 Bocksch, S. (2003) Assessment of Side Effects of BAS 516 04 F to the Honey Bee, Apis 

mellifera L. in the Laboratory. Project Number: 2003/1012075, 20091103/01/BLEU. 

Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 29 p.

48580701 Becker, R.; Lueckmann, J. (2011) Response of BASF Regarding EFED Review: Review 

(DP Barcode D363523) of Formulated Product Pollinator Toxicity Tests of Pristine 

(Boscalid (PC Code 128008) and Pyraclostrobin (PC Code 099100): Assessment of 

Potential Side-Effects of Pristine (BAS 516 04 F) on the Honeybee (Apis mellifera L.) in a 

Bee Brood Study under Semi-Field Conditions in Germany 2009.2 (MRID 484702-01). 

Project Number: 2011/1209608. Unpublished study prepared by BASF Corporation. 17p. 

48600218 Kling, A. (2011) BAS 640 00 F - Acute Oral and Contact Toxicity to the Honey Bee Apis 

mellifera L. in the Laboratory. Project Number: 2011/1232121/OCR, S11/03380, 381192. 

Unpublished study prepared by Eurofins - GAB GmbH. 36p. 

850.3040 Field testing for pollinators 

MRID Citation Reference 

 

48727101 Lawrence, J. (2012) Determination of Residues of Pristine Fungicide (Pyraclostrobin + 

Boscalid) in Royal Jelly and Pollen in Almond Trees in Central California. Project 

Number: 373827, 2012/7000038, S12/00011. Unpublished protocol prepared by EurofinsAgrisearch Americas, Inc. 31p.

49009301 Bocksch, S. (2012) Determination of Side-effects of BAS 510 01 F on Brood Development 

of the Honeybee (Apis mellifera L.) in a Feeding Test. Project Number: 411272, 

S11/02725, S11/02725/01. Unpublished study prepared by Eurofins AgroScience Services 

EcoChem GmbH. 286p.

49009302 Schneider, C.; Becker, R. (2012) Risk Perspective of Boscalid and its Potential Effects on 

Honey Bee Brood. Project Number: 2012/1166152. Unpublished study prepared by BASF 

SE. 18p.
52 

49009303 Niederdrenk, S.; Schneider, C. (2012) Assessments of Effects of BAS 516 04 F on the 

Production of Honey Bee Queens (Apis mellifera L.) in a Semi Field Study in Phacelia 

tanacetifolia. Project Number: 2012/1261980. Unpublished study prepared by BASF SE. 

74p.

49009304 Lawrence, J.; Riley, M. (2012) Determination of Residues of Pristine Fungicide 

(Pyraclostrobin + Boscalid) in Royal Jelly and Pollen in Almond Trees in Central 

California: Final Report. Project Number: 373827 S12/00011 2012/7005408. Unpublished 

study prepared by Eurofins-Agrisearch Americas Inc. 242p. 

850.4100 Terrestrial plant toxicity, Tier 1 (seeding emergence) 

MRID Citation Reference 

 

47627401 Martin, J.; Holmes, C. (2008) BAS 510 04 F - Seedling Emergence Test. Project Number: 

986/6181, 321609, 2008/7014468. Unpublished study prepared by Springborn Smithers 

Laboratories. 171 p.

850.4150 Terrestrial plant toxicity, Tier 1 (vegetative vigor) 

MRID Citation Reference 

 

47627402 Martin, J.; Holmes, C. (2008) BAS 510 04 F - Vegetative Vigor Test. Project Number: 

986/6182, 321610, 2008/7014469. Unpublished study prepared by Springborn Smithers 

Laboratories. 162 p.

850.4225 Seedling emergence, Tier II 

MRID Citation Reference 

 

47627401 Martin, J.; Holmes, C. (2008) BAS 510 04 F - Seedling Emergence Test. Project Number: 

986/6181, 321609, 2008/7014468. Unpublished study prepared by Springborn Smithers 

Laboratories. 171 p.

850.4250 Vegetative vigor, Tier II 

MRID Citation Reference 

 
53 

47627402 Martin, J.; Holmes, C. (2008) BAS 510 04 F - Vegetative Vigor Test. Project Number: 

986/6182, 321610, 2008/7014469. Unpublished study prepared by Springborn Smithers 

Laboratories. 162 p.

850.1735 Whole sediment: acute freshwater invertebrates 

MRID Citation Reference 

 

48600216 Domer, S. (2011) Acute Toxicity of BAS 640 00 F to Daphnia magna Straus in a 48 Hour 

Static Test. Project Number: 2011/1125619/OCR, 381190. Unpublished study prepared by 

BASF SE. 25p.

81-1 Acute oral toxicity in rats 

MRID Citation Reference 

 

46210601 Gamer, A.; Hellwig, J. (2004) BAS 516 02F - Acute Oral Toxicity Study in Wister (sic) Rats - 

UDP Method: Final Report. Project Number: 2003/1007136, 10A0657/001152. Unpublished study 

prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology. 23 p.

47285606 Gamer, A.; Landsiedel, R. (2007) BAS 516 09 F: Acute Oral Toxicity Study in Rats. Project 

Number: 10A0421/061132, 2007/1018931. Unpublished study prepared by BASF 

Aktiengesellschaft. 22 p.

81-2 Acute dermal toxicity in rabbits or rats 

MRID Citation Reference 

 

47285607 Remmele, M.; Landsiedel, R. (2007) BAS 516 09 F: Acute Dermal Toxicity Study in Rats. Project 

Number: 11A0421/061133, 2007/1018932. Unpublished study prepared by BASF 

Aktiengesellschaft. 26 p.

81-3 Acute inhalation toxicity in rats 

MRID Citation Reference 
54 

 

47285608 Ma-Hock, L.; Mellert, W. (2007) BAS 516 09 F: Acute Inhalation Toxicity Study in Wistar Rats: 

4-Hour Liquid Aerosol Dust Exposure. Project Number: 13I0421/067022, 2007/1045024. 

Unpublished study prepared by BASF Aktiengesellschaft. 43 p.

81-4 Primary eye irritation in rabbits 

MRID Citation Reference 

 

47285609 Remmele, M.; Landsiedel, R. (2007) BAS 516 09 F: Acute Eye Irritation in Rabbits. Project 

Number: 11H0421/062245, 2007/1018934. Unpublished study prepared by BASF 

Aktiengesellschaft. 23 p.

81-5 Primary dermal irritation 

MRID Citation Reference 

 

46242301 Manciaux, X. (2003) BAS 510 02 F Acute Dermal Irritation in Rabbits: Amended Final Report. 

Project Number: 20686/TAL, 18H0393/009023, 2004/5000275. Unpublished study prepared by 

Centre International de Toxicologie. 22 p.

46270101 Manciaux, X. (2003) BAS 510 02 F: Acute Dermal Irritation in Rabbits. Project Number: 

20886/TAL, 18H0393/009023, 2004/5000275. Unpublished study prepared by Centre International 

de Toxicologie. 22 p.

47285610 Landsiedel, R.; Remmele, M. (2007) BAS 516 09 F: Acute Dermal Irritation/Corrosion in Rabbits. 

Project Number: 2007/1018933, 18H0421/062244. Unpublished study prepared by BASF 

Aktiengesellschaft. 22 p.

870.1100 Acute oral toxicity 

MRID Citation Reference 

 
55 

46210601 Gamer, A.; Hellwig, J. (2004) BAS 516 02F - Acute Oral Toxicity Study in Wister (sic) Rats - 

UDP Method: Final Report. Project Number: 2003/1007136, 10A0657/001152. Unpublished study 

prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology. 23 p.

47013505 Gamer, A.; Landsiedel, R. (2006) BAS 516 08 F: Acute Oral Toxicity in Rats. Project Number: 

10A0301/051096, 2006/1010589. Unpublished study prepared by BASF Aktiengesellschaft, Labor 

fuer Oekotoxicologie. 23 p.

47285606 Gamer, A.; Landsiedel, R. (2007) BAS 516 09 F: Acute Oral Toxicity Study in Rats. Project 

Number: 10A0421/061132, 2007/1018931. Unpublished study prepared by BASF 

Aktiengesellschaft. 22 p. 

48311302 Durando, J. (2010) Acute Oral Toxicity Up and Down Procedure in Rats: TC-308. Project Number: 

29599, 2713, P320/UDP/WMG. Unpublished study prepared by Eurofins/Product Safety 

Laboratories. 18 p.

48600207 Cords, S.; Lammer, E. (2011) BAS 640 00 F - Acute Oral Toxicity Study in Rats. Project Number: 

2011/1072531/OCR, 11/BF/OT086, 10A0047/10X259. Unpublished study prepared by Bioassay 

Labor fuer Biologische Analytik GmbH. 26p.

48707803 Durando, J. (2011) Acute Oral Toxicity Up and Down Procedure in Rats: FT09. Project Number: 

P320/UDP, 30253. Unpublished study prepared by Eurofins/Product Safety Laboratories. 17p.

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical 

for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 

510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p. 

870.1200 Acute dermal toxicity 

MRID Citation Reference 

 

47013506 Gamer, A.; Landsiedel, R. (2006) BAS 516 08 F: Acute Dermal Toxicity Study in Rats. Project 

Number: 11A0301/051097, 2006/1010590. Unpublished study prepared by BASF 

Aktiengesellschaft, Labor fuer Oekotoxicologie. 25 p.

47285607 Remmele, M.; Landsiedel, R. (2007) BAS 516 09 F: Acute Dermal Toxicity Study in Rats. Project 

Number: 11A0421/061133, 2007/1018932. Unpublished study prepared by BASF 

Aktiengesellschaft. 26 p.
56 

48311303 Durando, J. (2010) TC-308: Acute Dermal Toxicity Study in Rats. Project Number: 29600, 

P322/RAT/WMG, 2714. Unpublished study prepared by Eurofins/Product Safety Laboratories. 16 

p.

48600208 Cords, S.; Lammer, E. (2011) BAS 640 00 F - Acute Dermal Toxicity Study in Rats. Project 

Number: 2011/1072532/OCR, 11/BF/DT087, 11A0047/10X260. Unpublished study prepared by 

Bioassay Labor fuer Biologische Analytik GmbH. 28p.

48707804 Durando, J. (2011) Acute Dermal Toxicity Study in Rats: FT09. Project Number: P322/RAT, 

30254. Unpublished study prepared by Eurofins/Product Safety Laboratories. 15p. 

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical 

for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 

510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p. 

870.1300 Acute inhalation toxicity 

MRID Citation Reference 

 

47013507 Ma-Hock, L.; Landsiedel (2006) BAS 516 08 F: Acute Inhalation Toxicity Study in Wistar Rats: 4-

Hour Dust Exposure. Project Number: 13I0301/057014, 2006/1007449. Unpublished study 

prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 30 p.

47285608 Ma-Hock, L.; Mellert, W. (2007) BAS 516 09 F: Acute Inhalation Toxicity Study in Wistar Rats: 

4-Hour Liquid Aerosol Dust Exposure. Project Number: 13I0421/067022, 2007/1045024. 

Unpublished study prepared by BASF Aktiengesellschaft. 43 p.

48311304 Durando, J. (2010) TC-308: Acute Inhalation Toxicity Study in Rats. Project Number: 

P330/WMG, 29601, 2709. Unpublished study prepared by Eurofins/Product Safety Laboratories. 

23 p.

48600209 Wittmer, E. ; Landsiedel, R. (2011) BAS 640 00 F - Acute Inhalation Toxicity Study in Wistar 

Rats - 4-Hour Liquid Aerosol Exposure (Head-Nose Only). Project Number: 2011/1223793/OCR, 

350935, 13I0047/10I106. Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer 

Oekotoxicologie. 89p.

48707805 Durando, J. (2011) Acute Inhalation Toxicity Study in Rats: FT09. Project Number: P330, 30255. 

Unpublished study prepared by Eurofins/Product Safety Laboratories. 23p. 
57 

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical 

for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 

510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p. 

870.2400 Acute eye irritation 

MRID Citation Reference 

 

47013508 Remmele, M.; Landsiedel, R. (2006) BAS 516 08 F: Acute Eye Irritation in Rabbits. Project 

Number: 11H0301/052238, 2006/1010592. Unpublished study prepared by BASF 

Aktiengesellschaft, Labor fuer Oekotoxicologie. 22 p.

47285609 Remmele, M.; Landsiedel, R. (2007) BAS 516 09 F: Acute Eye Irritation in Rabbits. Project 

Number: 11H0421/062245, 2007/1018934. Unpublished study prepared by BASF 

Aktiengesellschaft. 23 p.

47322901 Remmele, M.; Landsiedel, R. (2007) BAS 516 08 F - Acute Eye Irritation in Rabbits. Project 

Number: 2007/1050817, 11H0301/052348. Unpublished study prepared by BASF 

Aktiengesellschaft. 25 p.

48311305 Durando, J. (2010) TC-308: Primary Eye Irritation Study in Rabbits. Project Number: 29602, 

P324/WMG. Unpublished study prepared by Eurofins/Product Safety Laboratories. 16 p.

48600210 Wolf, T. (2011) BAS 640 00 F - Acute Eye Irritation / Corrosion in Rabbits. Project Number: 

2011/1072533/OCR, 11IH0047/10X258, SL/LT/099/11. Unpublished study prepared by 

Seibersdorf Labor GmbH. 26p.

48707806 Durando, J. (2011) Primary Eye Irritation Study in Rabbits: FT09. Project Number: P324, 30256. 

Unpublished study prepared by Eurofins/Product Safety Laboratories. 16p. 

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical 

for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 

510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p. 

870.2500 Acute dermal irritation 

MRID Citation Reference 
58 

 

46242301 Manciaux, X. (2003) BAS 510 02 F Acute Dermal Irritation in Rabbits: Amended Final Report. 

Project Number: 20686/TAL, 18H0393/009023, 2004/5000275. Unpublished study prepared by 

Centre International de Toxicologie. 22 p.

46270101 Manciaux, X. (2003) BAS 510 02 F: Acute Dermal Irritation in Rabbits. Project Number: 

20886/TAL, 18H0393/009023, 2004/5000275. Unpublished study prepared by Centre International 

de Toxicologie. 22 p.

47013509 Remmele, M.; Landsiedel, R. (2006) BAS 516 08 F: Acute Dermal Irritation/Corrosion in Rabbits. 

Project Number: 18H0301/052237, 2006/1010591. Unpublished study prepared by BASF 

Aktiengesellschaft, Labor fuer Oekotoxicologie. 20 p.

47285610 Landsiedel, R.; Remmele, M. (2007) BAS 516 09 F: Acute Dermal Irritation/Corrosion in Rabbits. 

Project Number: 2007/1018933, 18H0421/062244. Unpublished study prepared by BASF 

Aktiengesellschaft. 22 p.

48311306 Durando, J. (2010) TC-308: Primary Skin Irritation Study in Rabbits. Project Number: 29603, 

P326/WMG, 2711. Unpublished study prepared by Eurofins/Product Safety Laboratories. 16 p. 

48600211 Wolf, T. (2011) BAS 640 00 F - Acute Dermal Irritation / Corrosion in Rabbits. Project Number: 

2011/1072534/OCR, 18H0047/10X261, SL/LT/188/11. Unpublished study prepared by 

Seibersdorf Labor GmbH. 23p.

48707807 Durando, J. (2011) Primary Skin Irritation Study in Rabbits: FT09. Project Number: P326, 30257. 

Unpublished study prepared by Eurofins/Product Safety Laboratories. 16p.

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical 

for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 

510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p. 

870.2600 Skin sensitization 

MRID Citation Reference 

 
59 

49258106 Hastings, C. (2014) Support for Use of the Existing Toxicology Database on Boscalid Technical 

for Registration of Boscalid ISO Water Moist Manufacturing Use Product (Boscalid MP) (BAS 

510 09 F). Project Number: 2014/7000742. Unpublished study prepared by BASF Corporation. 7p. 

83-4 2-generation repro.-rat 

MRID Citation Reference 

 

45404906 

Schilling, K.; Gembardt, C.; van Ravenzwaay, B. (2001) BAS 510 F Two Generation Toxicity Study 

in Wistar Rats Continuous Dietary Administration: Final Report: Lab Project Number: 

70R0179/97136: 2001/1000117. Unpublished study prepared by BASF Aktiengesellschaft. 924 p. 

{OPPTS 870.3800}

 Non-Guideline Study 

MRID Citation Reference 

 

45405008 Holmes, C.; Aufderheide, J. (2001) Acute Toxicity of BAS 510 F in Whole Sediment to the 

Amphipod, Hyalella azteca: Lab Project Number: 2001/5000043: 64340: 46319. Unpublished study 

prepared by ABC Laboratories, Inc. 48 p. {OPPTS 850.1735}

45405009 Holmes, C.; Aufderheide, J. (2001) Acute Toxicity of BAS 510 F in Whole Sediment to the 

Amphipod, Hyalella azteca: Lab Project Number: 2001/5000043: 64340: 46319. Unpublished study 

prepared by ABC Laboratories, Inc. 48 p. {OPPTS 850.1735}

45405215 Fent, G. (2001) Degradation and Distribution of BAS 510 F in a Water-Sediment System Under 

Outdoor Conditions: Final Report: Lab Project Number: 2000/1017038: BAS37. Unpublished study 

prepared by BASF Aktiengesellschaft. 42 p.

48298805 Mullin, C.; Frazier, M.; Frazier, J.; et al. (2010) High Levels of Miticides and Agrochemicals in 

North American Apiaries: Implications for Honey Bee Health. PLoS ONE: 5(3): 1-19. 

48600215 Weltje, L. (2005) Chronic Toxicity of Boscalid (BAS 510 F) to the Non-Biting Midge Chironomus 

riparius Exposed via Spiked-Sediment. Project Number: 2005/1022464/OCR, 232363. Unpublished 

study prepared by BASF SE. 31p.
60 

48600217 Hoffmann, F. (2011) Effect of BAS 640 00 F on the Growth of the Green Alga Pseudokirchneriella 

subcapitata. Project Number: 2011/1150026/OCR, 381189. Unpublished study prepared by BASF 

SE. 35p.

48600219 Schoebinger, U. (2011) Acute Toxicity of BAS 640 00 F on Earthworms, Eisenia fetida in Artificial 

Soil with 5 % Peat. Project Number: 2011/1232120/OCR, S11/03381, S11/03381/L1/NLEF. 

Unpublished study prepared by Eurofins - GAB GmbH. 30p. 

48727201 Schneider, C. (2012) Assessments of Effects of BAS 516 04 F on the Production of Honeybee 

Queens (Apis mellifera L.) in a Semi Field Study in Phacelia tanacetifolia. Project Number: 

2012/7000030. Unpublished study prepared by BASF SE. 19p.

48727202 Schneider, C. (2012) An Overview of Potential Factors Influencing Honey Bee Queen Development. 

Project Number: 2012/1009644. Unpublished study prepared by BASF SE. 22p.

49361801 Royer, S. (2014) Effect of Reg. No. 300355 (BAS 510 F) on Survival and Development of Honey 

Bee Brood (Apis mellifera), Using an In Vitro Rearing Method. Project Number: 2013/1275399, 

428347. Unpublished study prepared by BASF SE. 35p.
Appendix D. Screening Tool for Inhalation Risk (v. 1.0) 

Boscalid TGAI (Based on Rat Inhalation Study, MRID 4540816) 

95.3% a.i. 
Pristine (Based on Rat Inhalation Study, MRID 4728560) 

Approx. 24% boscalid, 12% pyraclostrobin 

Endpoint adjusted for percent boscalid a.i. 
Appendix E. Results from Screening Imbibition Program (SIP)